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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: arm Recall Date to: 02/20/2015
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The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and... 2 06/26/2015 International Rehabilitative Sciences, Inc.
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive O... 2 02/19/2015 Mako Surgical Corporation
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgi... 2 02/13/2015 Intuitive Surgical, Inc.
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Sur... 2 02/13/2015 Intuitive Surgical, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-compon... 2 02/07/2015 Siemens Medical Solutions USA, Inc.
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 0... 1 02/06/2015 Teleflex Medical
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moi... 1 02/06/2015 Teleflex, Inc.
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and muscu... 2 01/13/2015 GE OEC Medical Systems, Inc
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musc... 2 01/13/2015 GE OEC Medical Systems, Inc
Harmony® vLED Surgical Lighting System, one unit packaged per box The Harmony® vLED Surgical Lighti... 2 01/07/2015 Steris Corporation
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/... 2 12/19/2014 Mindray DS USA, Inc. dba Mindray North America
Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures su... 1 12/16/2014 Customed, Inc
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a si... 2 12/16/2014 Medtronic Perfusion Systems
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commer... 2 12/16/2014 American Medical Systems, Inc.
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product... 2 12/16/2014 Snug Seat Inc
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nit... 2 12/12/2014 INO Therapeutics (dba Ikaria)
Dharma Cavity Varnish 15mL 2 12/01/2014 Dharma Research, Inc.
Dharma Cavity Varnish with Fluoride 2 12/01/2014 Dharma Research, Inc.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyC... 2 11/13/2014 Fisher & Paykel Healthcare, Ltd.
OEC® MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with ... 2 11/07/2014 GE OEC Medical Systems, Inc
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform pr... 2 10/29/2014 Tecan US, Inc.
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeab... 2 10/21/2014 Estill Medical Technologies, Inc
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M810... 2 10/21/2014 Philips Medical Systems, Inc.
StarMedTec LightTrail® Reusable Fibers, 365 um; Material/Part Number: 6453 2 10/08/2014 Boston Scientific Corporation
StarMedTec LightTrail® Reusable Fibers, 600 um; Material/Part Number: 6455 2 10/08/2014 Boston Scientific Corporation
StarMedTec LightTrail® Reusable Fibers, 800 um; Material/Part Number: 6457 2 10/08/2014 Boston Scientific Corporation
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert... 2 10/02/2014 Gendex Corp
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow sy... 2 09/25/2014 Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow ... 2 09/25/2014 Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision... 2 09/25/2014 Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precisio... 2 09/25/2014 Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow ... 2 09/25/2014 Vapotherm, Inc.
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow s... 2 09/25/2014 Vapotherm, Inc.
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or A... 2 09/25/2014 Spacelabs Healthcare Inc
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and t... 2 09/24/2014 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(e... 2 09/22/2014 Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene t... 2 09/22/2014 Peters Surgical
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim ... 2 09/16/2014 Advanced Photonic Systems, LLC
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRA... 1 08/29/2014 Customed, Inc
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend,... 2 08/27/2014 Thermedx LLC
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMO... 2 08/26/2014 Curbell Medical, Inc.
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled de... 2 08/14/2014 Nellcor Puritan Bennett Inc. (dba Covidien LP)
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controll... 2 08/14/2014 Nellcor Puritan Bennett Inc. (dba Covidien LP)
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, ... 2 08/07/2014 ICU Medical, Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the U... 2 08/01/2014 Carestream Health Inc.
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE® Redi-Code+... 1 07/22/2014 DIABETIC SUPPLY OF SUNCOAST, INC.
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To ... 2 07/16/2014 Excelsior Medical Corp
SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems... 2 07/15/2014 Stryker Communications
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom syste... 2 07/15/2014 Stryker Communications
SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head ... 2 07/15/2014 Stryker Communications
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom sys... 2 07/15/2014 Stryker Communications
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom sy... 2 07/15/2014 Stryker Communications
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.11... 2 07/02/2014 Synthes, Inc.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stat... 2 06/30/2014 Claymount Assembli
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stat... 2 06/30/2014 Claymount Assembli
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lig... 2 06/23/2014 Steris Corporation
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm condi... 2 06/23/2014 Spacelabs Healthcare Inc
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compo... 2 06/22/2014 Baxter Corporation Englewood
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethyl... 2 06/09/2014 Summit Medical, Inc.
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 G... 2 06/04/2014 Stryker Instruments Div. of Stryker Corporation
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS... 2 06/04/2014 Intuitive Surgical, Inc.
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The ... 2 06/03/2014 Spacelabs Healthcare Inc
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective W... 2 05/22/2014 Smiths Medical ASD, Inc.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is use... 2 05/16/2014 Philips Medical Systems, Inc.
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, disp... 2 05/13/2014 Mindray DS USA, Inc. dba Mindray North America
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for... 2 05/10/2014 Zimmer, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK 2 05/09/2014 Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK 2 05/09/2014 Medtronic Navigation, Inc.
Panda® Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neona... 2 05/06/2014 GE Healthcare
Panda® Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neo... 2 05/06/2014 GE Healthcare
Giraffe® Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who ar... 2 05/06/2014 GE Healthcare
Panda® iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who... 2 05/06/2014 GE Healthcare
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS ... 2 05/02/2014 INO Therapeutics (dba Ikaria)
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum V... 1 04/25/2014 Baxter Healthcare Corp.
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. ... 2 04/24/2014 Varian Medical Systems, Inc.
Smiths Medical HOTLINE® Fluid Warming Set L-80. Product Usage: intended for the delivery of wa... 2 04/09/2014 Smiths Medical ASD, Inc.
Smiths Medical HOTLINE® Fluid Warming Set L-70. Product Usage: intended for the delivery of warm... 2 04/09/2014 Smiths Medical ASD, Inc.
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Int... 2 04/04/2014 Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Int... 2 04/04/2014 Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Int... 2 04/04/2014 Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Int... 2 04/04/2014 Intuitive Surgical, Inc.
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk sur... 2 03/26/2014 Teleflex Medical
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders a... 2 03/14/2014 DeRoyal Industries Inc
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 T... 2 03/11/2014 GE Healthcare, LLC
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, a... 2 03/07/2014 Mindray DS USA, Inc. dba Mindray North America
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the... 2 03/06/2014 GE Healthcare, LLC
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's R... 2 03/04/2014 Mako Surgical Corporation
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The ... 2 02/28/2014 Medtronic Navigation, Inc.
XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Remo... 2 02/26/2014 Winco Mfg., LLC
DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Pa... 2 02/26/2014 Winco Mfg., LLC
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: Fo... 2 02/26/2014 Dako North America Inc.
PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar,... 2 02/26/2014 Winco Mfg., LLC
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitat... 1 02/25/2014 GE Healthcare, LLC
GE Healthcare - Giraffe® and Panda® iRes Infant Warmer Product Usage: The infant radiant warme... 1 02/25/2014 GE Healthcare, LLC
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) ... 2 02/25/2014 Instrumentarium Dental, PaloDEx Group Oy
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Steril... 2 02/20/2014 Medtronic Inc. Cardiac Rhythm Disease Management
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discover... 2 02/14/2014 GE Healthcare, LLC
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple a... 2 02/04/2014 GE Healthcare, LLC
Giraffe® Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road La... 2 02/03/2014 GE Healthcare
Panda iRes® Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568... 2 02/03/2014 GE Healthcare
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa... 2 02/03/2014 Nipro Diagnostics, Inc.
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa... 2 02/03/2014 Nipro Diagnostics, Inc.
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical p... 2 01/30/2014 Merit Medical Systems, Inc.
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a ... 2 01/28/2014 GE Healthcare, LLC
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of pat... 2 01/23/2014 Medrad Mr Inc
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D... 2 01/22/2014 GE Healthcare, LLC
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11... 2 12/29/2013 Baxter Healthcare Corp.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a m... 2 12/27/2013 Philips Medical Systems, Inc.
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imagin... 2 12/24/2013 Ziehm Imaging Inc
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging 2 12/24/2013 Ziehm Imaging Inc
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Pro... 1 12/17/2013 Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 ... 1 12/17/2013 Abbott Diabetes Care, Inc.
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K1222... 2 12/12/2013 GE Healthcare, LLC
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Se... 2 11/25/2013 Mindray DS USA, Inc. dba Mindray North America
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhyt... 2 11/18/2013 Spacelabs Healthcare, Llc
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monito... 2 11/08/2013 Spacelabs Healthcare, Llc
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision ... 2 11/08/2013 Baxter Healthcare Corp.
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equ... 2 11/06/2013 Steris Corporation
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Produc... 2 11/05/2013 Insulet Corporation
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) P... 2 11/05/2013 Insulet Corporation
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical ... 2 11/04/2013 Intuitive Surgical, Inc.
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illumina... 3 11/04/2013 Intuitive Surgical, Inc.
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxt... 2 10/30/2013 Baxter Healthcare Corp.
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Pos... 2 10/25/2013 Philips Medical Systems (Cleveland) Inc
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobi... 2 10/24/2013 GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical... 2 10/21/2013 Aesculap, Inc.
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array tran... 2 10/18/2013 SonoSite, Inc.
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human ... 2 09/24/2013 Stryker Endoscopy
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient mo... 2 09/19/2013 GE Healthcare, LLC
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. 2 08/28/2013 Siemens Medical Solutions USA, Inc
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5... 2 08/27/2013 Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. ... 2 08/14/2013 Medtronic Inc. Cardiac Rhythm Disease Management
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex f... 2 08/06/2013 ASO, LLC
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, pat... 2 08/06/2013 Arjo, Inc. dba ArjoHuntleigh
Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part... 2 07/20/2013 Philips Healthcare Inc.
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot... 2 07/01/2013 Surgical Instrument Service And Savings, Inc.
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT1... 2 07/01/2013 Surgical Instrument Service And Savings, Inc.
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm... 2 07/01/2013 Surgical Instrument Service And Savings, Inc.
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). ... 2 06/11/2013 Embla System Llc
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-a... 2 05/17/2013 Hologic, Inc.
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Flurosc... 2 05/17/2013 Hologic, Inc.
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produ... 2 05/01/2013 GE Healthcare, LLC
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device o... 2 05/01/2013 GE Healthcare, LLC
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC... 2 04/22/2013 Stellate Systems
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Gluco... 2 04/18/2013 Nipro Diagnostics, Inc.
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes pr... 2 04/13/2013 Intuitive Surgical, Inc.
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical Sys... 2 04/13/2013 Intuitive Surgical, Inc.
Giraffe OmniBed® and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healt... 1 04/05/2013 GE Healthcare, LLC
Smiths Medical, BCI® Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO... 1 03/29/2013 Smiths Medical ASD, Inc.
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable N... 2 03/28/2013 Cardinal Health
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable N... 2 03/28/2013 Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip... 2 03/28/2013 Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable ... 2 03/28/2013 Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable... 2 03/28/2013 Cardinal Health
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobil... 2 03/08/2013 Medtronic Navigation, Inc.
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns ... 2 02/14/2013 Philips Healthcare Inc.
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physi... 2 02/14/2013 Viterion TeleHealthcare Llc
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Phys... 2 02/14/2013 Viterion TeleHealthcare Llc
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological pati... 2 02/14/2013 Viterion TeleHealthcare Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical S... 2 01/17/2013 Spacelabs Healthcare, Llc
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigati... 2 01/09/2013 Stryker Communications, Inc.
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The... 2 01/09/2013 Zimmer, Inc.
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda ... 2 12/28/2012 Medtronic Inc. Cardiac Rhythm Disease Management
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Min... 2 12/17/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a requir... 1 12/14/2012 Bunnell, Inc.
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Ma... 2 12/11/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The in... 2 12/10/2012 Philips Healthcare Inc.
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cool... 1 11/30/2012 Natus Medical Incorporated
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulati... 2 11/29/2012 Kimberly-Clark Corporation
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs... 2 11/20/2012 Spacelabs Healthcare, Llc
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconst... 2 10/25/2012 Baxa Corporation
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood b... 2 10/22/2012 Ethicon, Inc.
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Ba... 2 10/16/2012 Terumo Cardiovascular Systems Corporation
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No... 2 10/10/2012 Winco Mfg., LLC
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***M... 2 10/10/2012 Winco Mfg., LLC
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vascu... 2 09/25/2012 Abbott Vascular
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device i... 2 09/25/2012 Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is ... 2 09/25/2012 Hologic, Inc.
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), P... 2 09/25/2012 Philips Medical Systems (Cleveland) Inc
STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table... 2 09/20/2012 Steris Corporation
A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. ... 2 09/17/2012 Steris Corporation
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated fo... 2 09/14/2012 Zoe Medical Incorporated
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various ... 2 09/14/2012 Spacelabs Healthcare, Llc
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme Gmb... 2 09/05/2012 Trumpf Medical Systems, Inc.
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277... 2 08/30/2012 Philips Healthcare Inc.
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufa... 2 08/24/2012 Cisco Systems Inc
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16... 2 08/22/2012 Philips Medical Systems (Cleveland) Inc
Medtronic O-arm® Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027... 2 08/22/2012 Medtronic Navigation, Inc.
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a f... 2 08/20/2012 Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully... 2 08/20/2012 Beckman Coulter Inc.
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a... 2 08/15/2012 Philips Healthcare Inc.
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming ... 2 08/09/2012 Kimberly-Clark Corporation
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm ... 2 08/01/2012 GE OEC Medical Systems, Inc
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3),... 2 07/31/2012 Sunrise Medical (US) LLC
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrumen... 2 07/27/2012 Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrumen... 2 07/27/2012 Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrumen... 2 07/27/2012 Intuitive Surgical, Inc.
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm dra... 2 07/27/2012 Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrume... 2 07/27/2012 Intuitive Surgical, Inc.
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm d... 2 07/27/2012 Intuitive Surgical, Inc.
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Imag... 1 07/24/2012 GE OEC Medical Systems, Inc
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer size... 2 07/20/2012 Westone Laboratories, Inc.
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is inte... 2 07/19/2012 Teleflex Medical
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to pr... 2 07/18/2012 GE OEC Medical Systems, Inc
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locat... 2 07/18/2012 GE OEC Medical Systems, Inc
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patien... 2 07/16/2012 Spacelabs Healthcare, Llc
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MO... 2 07/09/2012 Vital Signs Devices, a GE Healthcare Company
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Mic... 2 07/09/2012 Smiths Medical ASD, Inc.
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and B... 2 06/21/2012 Medtronic Navigation, Inc.
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopat... 2 06/20/2012 Natus Medical Incorporated
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the op... 2 06/14/2012 Stryker Instruments Div. of Stryker Corporation
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the o... 2 06/14/2012 Stryker Instruments Div. of Stryker Corporation
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- C... 1 06/13/2012 Baxter Healthcare Corporation
Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Moni... 2 06/05/2012 Spacelabs Healthcare, Llc
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feat... 2 05/30/2012 Siemens Medical Solutions USA, Inc.
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feat... 2 05/30/2012 Siemens Medical Solutions USA, Inc.
HPBLUE: HARMONIC® Blue Hand Piece; HP054: HARMONIC® Hand Piece; Non-Sterile products are individuall... 2 05/25/2012 Ethicon Endo-Surgery Inc
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass ... 2 05/24/2012 Cincinnati Sub-Zero Products Inc
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic ... 2 05/22/2012 Philips Medical Systems (Cleveland) Inc
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***... 2 05/21/2012 Diamedix Corporation
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***F... 3 05/10/2012 Diamedix Corporation
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. 2 05/09/2012 CaridianBCT, Inc.
Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Securit... 2 04/28/2012 Stanley Security Solutions, Inc.
UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal... 2 04/27/2012 Stanley Security Solutions, Inc.
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE ... 2 04/25/2012 Winco Mfg., LLC
ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE C... 2 04/25/2012 Winco Mfg., LLC
ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part: "***ELITE CARE... 2 04/25/2012 Winco Mfg., LLC
CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON... 2 04/25/2012 Winco Mfg., LLC
CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550... 2 04/25/2012 Winco Mfg., LLC
Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monit... 2 04/23/2012 Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Boa... 2 04/23/2012 Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Boa... 2 04/23/2012 Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial Monitor... 2 04/23/2012 Terumo Cardiovascular Systems Corporation
ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (1... 2 04/18/2012 Teva Pharmaceuticals USA, Inc.
Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & ... 2 04/16/2012 Ziehm Imaging Inc
Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of... 2 04/09/2012 Baxa Corporation
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutio... 2 04/05/2012 Baxa Corporation
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Di... 2 03/23/2012 Qrs Diagnostic
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component ... 2 03/21/2012 Leica Microsystems, Inc.
Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recordi... 2 03/01/2012 Philips Healthcare Inc.
Premier Care Recliner Model 5570. Brochure: "***Premier Care Recliner 5570/5574***Winco***ISO 90... 2 02/26/2012 Winco Mfg., LLC
Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***... 2 02/26/2012 Winco Mfg., LLC
V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an acc... 1 02/21/2012 Flight Medical Ltd.
ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless ste... 2 02/19/2012 Geomed Medizin-Technik Gmbh & Co.
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer Healt... 2 02/15/2012 Viterion TeleHealthcare Llc
Hemotherm 48®C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The ... 2 02/07/2012 Cincinnati Sub-Zero Products Inc
Blanketrol II 48®C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanke... 2 02/07/2012 Cincinnati Sub-Zero Products Inc
GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH T... 2 02/02/2012 Philips Medical Systems (Cleveland) Inc
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Man... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufac... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. ... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church ... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwigh... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dw... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for ... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured... 2 01/25/2012 Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church ... 2 01/25/2012 Church & Dwight Inc
Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 ®. 2010-04 The X-coa... 3 01/24/2012 Terumo Cardiovascular Corporation
SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Sto... 3 01/23/2012 Quest International, Inc.
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. 2 01/20/2012 Siemens Medical Solutions USA, Inc
Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using ... 2 01/18/2012 Medtronic Inc. Cardiac Rhythm Disease Management
Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. ... 2 01/11/2012 Varian Medical Systems, Inc. Oncology Systems
INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (n... 1 01/11/2012 Ino Therapeutics
HOTLlNE® Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Se... 2 01/11/2012 Smiths Medical ASD, Inc.
HOTLlNE® Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use ... 2 01/11/2012 Smiths Medical ASD, Inc.
HOTLlNE® Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use ... 2 01/11/2012 Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use S... 2 01/11/2012 Smiths Medical ASD, Inc.
HOTLlNE® Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use S... 2 01/11/2012 Smiths Medical ASD, Inc.
Level 1® Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Sing... 2 01/11/2012 Smiths Medical ASD, Inc.
Level 1® Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Sin... 2 01/11/2012 Smiths Medical ASD, Inc.
Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC... 2 01/11/2012 Stellate Systems
Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640.... 2 12/01/2011 Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped ... 2 12/01/2011 Philips Medical Systems (Cleveland) Inc
Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku,... 2 12/01/2011 Atom Medical Corporation
Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, T... 2 12/01/2011 Atom Medical Corporation
Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Intervention... 2 12/01/2011 Toshiba American Medical Systems Inc
Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiological... 2 11/23/2011 Draeger Medical, Inc.
Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring S... 1 11/22/2011 Draeger Medical, Inc.
DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR... 2 11/18/2011 Cooper Surgical, Inc.
Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RI... 2 11/01/2011 Mako Surgical Corporation
Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Softwar... 2 10/31/2011 Picis Inc.
GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is intend... 2 10/26/2011 GE Healthcare, LLC
Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring press... 2 10/20/2011 Medtronic Perfusion Systems
LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) ... 2 10/19/2011 Lemaitre Vascular, Inc.
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 6001... 2 09/23/2011 Baxter Healthcare Corp.
CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & sto... 2 09/23/2011 Picis Inc.
Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbe... 2 09/13/2011 Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbe... 2 09/13/2011 Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, ... 2 09/13/2011 Philips Medical Systems (Cleveland) Inc
Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M Th... 2 09/07/2011 Picis Inc.
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, a... 2 09/01/2011 Cincinnati Sub-Zero Products Inc
enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Di... 2 08/19/2011 Vital Signs Devices, a GE Healthcare Company
Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch scree... 2 08/18/2011 Spacelabs Healthcare, Llc
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or A... 2 08/17/2011 Spacelabs Healthcare, Llc
Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are ... 2 08/12/2011 Hologic, Inc.
AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated ... 2 08/12/2011 Carefusion 211 Inc
AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2... 2 08/01/2011 Axiobionics, LLC
AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", ... 2 08/01/2011 Axiobionics, LLC
GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. ... 2 08/01/2011 Philips Medical Systems (Cleveland) Inc
AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Ve... 2 08/01/2011 Axiobionics, LLC
AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electr... 2 08/01/2011 Axiobionics, LLC
WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent... 2 07/27/2011 Cincinnati Sub-Zero Products Inc
Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAi... 2 07/14/2011 Cincinnati Sub-Zero Products Inc
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***... 2 07/06/2011 Smith & Nephew Inc.
ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is intended to... 2 07/01/2011 Cincinnati Sub-Zero Products Inc
ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended ... 2 07/01/2011 Cincinnati Sub-Zero Products Inc
Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pack, Steril... 2 06/22/2011 Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, Sterile, ... 2 06/22/2011 Terumo Cardiovascular Systems Corporation
Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453... 2 06/17/2011 Philips Healthcare Inc.
Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, ... 2 06/17/2011 Philips Healthcare Inc.
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 6001... 2 05/25/2011 Baxter Healthcare Corp.
MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** W... 2 05/20/2011 Mako Surgical Corporation
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Informat... 2 05/19/2011 Philips Healthcare Inc.
PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. ... 2 05/19/2011 Philips Medical Systems North America Co. Phillips
BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MA... 2 05/13/2011 Becton Dickinson & Company
Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numb... 2 05/06/2011 Siemens Medical Solutions USA, Inc.
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, ... 2 05/03/2011 Spacelabs Healthcare, Llc
ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solutions USA... 2 04/29/2011 Siemens Medical Solutions USA, Inc.
ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical Solutions... 2 04/29/2011 Siemens Medical Solutions USA, Inc.
ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens Medical ... 2 04/29/2011 Siemens Medical Solutions USA, Inc.
ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical... 2 04/29/2011 Siemens Medical Solutions USA, Inc.
S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User inf... 2 04/25/2011 Philips Medical Systems Nederlands
Posterior Referencing Instrumentation for the NEXGEN® COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR ... 2 04/14/2011 Zimmer Inc.
GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient mon... 2 04/08/2011 GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter patient mon... 2 04/08/2011 GE Healthcare, LLC
GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a ... 2 04/08/2011 GE Healthcare, LLC
***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use*... 2 04/05/2011 Linvatec Corp. dba ConMed Linvatec
Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is a... 2 04/05/2011 Steris Corporation
TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15... 2 04/04/2011 Siemens Medical Solutions USA, Inc.
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with mul... 2 04/01/2011 Pharmaplast S.A.E.
ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed; ACUSON S2000:... 2 03/28/2011 Siemens Medical Solutions USA, Inc., Mountain View, CA
ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with c... 2 03/28/2011 Siemens Medical Solutions USA, Inc., Mountain View, CA
Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and... 2 03/08/2011 Philips Medical Systems North America Co. Phillips
Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluorosco... 2 03/08/2011 Philips Medical Systems North America Co. Phillips
Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoro... 2 03/08/2011 Philips Medical Systems North America Co. Phillips
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, ... 2 01/27/2011 Philips Healthcare Inc.
Video Cart Articulating Arm product labeling is as follows: REF, VP6504, QTY1, Video Cart Articulat... 2 01/04/2011 Linvatec Corp. dba ConMed Linvatec
Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circula... 2 12/29/2010 Galil Medical
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H ... 2 12/21/2010 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 ... 2 12/21/2010 Advanced Bionics Corporation
CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms. 2 12/10/2010 Berchtold Corp.
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with th... 3 11/26/2010 Sonosite, Inc.
Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Nu... 2 11/23/2010 Medtronic Navigation, Inc.
VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lum... 1 11/18/2010 Micromedics, Inc.
Innova 2000 The principle system components include a C-arm, image acquisition, processing and archi... 2 11/16/2010 GE Healthcare, LLC
B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shi... 1 11/05/2010 B. Braun Medical Inc
B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shi... 1 11/05/2010 B. Braun Medical Inc
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a di... 1 11/01/2010 Medtronic Perfusion Systems
Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N - XL Care... 2 10/27/2010 Winco, Inc.
Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharm... 3 10/26/2010 Ferndale Laboratories, Inc.
Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X... 2 10/25/2010 Philips Medical Systems North America Co. Phillips
Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-r... 2 10/25/2010 Philips Medical Systems North America Co. Phillips
Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals wheneve... 2 09/29/2010 Philips Healthcare Inc.
Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever... 2 09/29/2010 Philips Healthcare Inc.
Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sod... 2 09/29/2010 Stryker Endoscopy
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300)... 3 09/23/2010 Abbott Point of Care Inc.
BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and I... 2 09/22/2010 Philips Medical Systems North America Co. Phillips
MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/A... 2 09/22/2010 Philips Medical Systems North America Co. Phillips
Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device des... 2 09/03/2010 Vital Signs Inc
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patie... 2 08/25/2010 Spacelabs Healthcare, Incorporated
Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. T... 1 08/13/2010 Ikaria Holdings
Hudson RCI® AQUA+® Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/An... 1 08/13/2010 Teleflex Medical
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radi... 2 07/26/2010 AGFA Corp.
Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. St... 2 07/17/2010 Medtronic Cardiovascular Revascularization & Surgical Therap
O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical appli... 2 07/13/2010 Medtronic Navigation, Inc.
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Mo... 2 06/11/2010 Ge Healthcare, Llc
Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820... 2 05/21/2010 Stryker Communications Corp
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured ... 3 05/21/2010 Ferring Pharmaceuticals Inc
Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a... 2 05/14/2010 Stryker Communications Corp
Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acum... 2 05/14/2010 Acumed LLC
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 m... 2 04/29/2010 Baxter Healthcare Corp.
Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Driv... 2 04/27/2010 Medela Inc
Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An ... 2 04/16/2010 AliMed Corporation
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 50... 2 04/01/2010 Steris Corporation
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 70... 2 04/01/2010 Steris Corporation
Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B129... 2 04/01/2010 Steris Corporation
Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufacture... 2 03/31/2010 Ulti Med, Inc.
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used ... 2 03/01/2010 Arizant Inc
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used ... 2 03/01/2010 Arizant Inc
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used w... 2 03/01/2010 Arizant Inc
TempPad® Cold Therapy Pad. The device is used for localized temperature therapy including hand, e... 2 02/04/2010 Cincinnati Sub-Zero Products Inc
FilteredFlo® Cardiac Blanket. The device is used to distribute heated air around a patient (for p... 2 02/04/2010 Cincinnati Sub-Zero Products Inc
AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromed... 3 12/23/2009 Micromedical Technologies, Inc
Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 72714212... 2 12/01/2009 Nutech Manufacturing Corp
Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R 2 12/01/2009 Nutech Manufacturing Corp
Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001 2 12/01/2009 Nutech Manufacturing Corp
SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predi... 2 11/23/2009 Philips Healthcare Inc.
SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM mon... 2 11/23/2009 Philips Healthcare Inc.
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside P... 2 11/23/2009 Philips Healthcare Inc.
STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumina... 2 11/23/2009 Steris Corp
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. S... 2 11/13/2009 Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. S... 2 11/13/2009 Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. S... 2 11/13/2009 Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. S... 2 11/13/2009 Boston Scientific Corporation
HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible illumination for th... 2 11/12/2009 MAQUET Inc.
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.)... 2 10/29/2009 Cincinnati Sub-Zero Products Inc
Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilize... 2 09/24/2009 Boston Scientific Corporation
Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized usin... 2 09/24/2009 Boston Scientific Corporation
Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylen... 2 09/24/2009 Boston Scientific Corporation
GE, Innova® 2000 The principle system components include a C-arm, image acquisition, processing and ... 2 09/24/2009 GE Medical Systems, LLC
Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 ... 2 09/04/2009 Enginivity LLC
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMR... 2 08/26/2009 Draeger Medical Systems, Inc.
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000,... 1 08/25/2009 Draeger Medical Systems, Inc.
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAI... 2 08/14/2009 GE Medical Systems, LLC
Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic a... 2 07/30/2009 Welch Allyn Protocol, Inc
SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitori... 1 05/19/2009 Respironics, Inc.
Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maxi... 2 02/09/2009 Medtronic Inc
Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 2 02/04/2009 Medtronic Navigation, Inc
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech pr... 2 02/03/2009 Advanced Bionics LLC
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd.... 2 02/03/2009 Advanced Bionics LLC
Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Rework... 2 01/16/2009 Stryker Communications Corp
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. 2 01/15/2009 Mainline Technology, Inc.
Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLC... 2 01/13/2009 Sterilmed Inc
Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED7... 2 01/13/2009 Sterilmed Inc
Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, G... 2 01/13/2009 Philips Medical Systems
Giraffe OmniBed®, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.g... 2 11/21/2008 Datex Ohmeda, Inc. dba GE Healthcare
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 ... 2 11/21/2008 Lifescan Inc
Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns ... 2 11/07/2008 Terumo Cardiovascular Systems Corporation
Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navig... 2 10/22/2008 Stryker Communications Corp
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human a... 2 09/26/2008 Medtronic Navigation, Inc.
HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte i... 2 09/25/2008 Philips Medical Systems
Innova 2000 The principle system components include a C-arm, image acquisition, processing and archi... 2 09/21/2008 GE Healthcare
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah. 2 09/20/2008 OEC Medical Systems, Inc
Innova 2000; The principle system components include a C-arm, image acquisition, processing and arch... 2 09/20/2008 GE Healthcare
Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve. 2 09/19/2008 Ascent Healthcare Solutions, Inc.
Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile proced... 2 09/19/2008 Ascent Healthcare Solutions, Inc.
Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressible limb sle... 2 09/19/2008 Ascent Healthcare Solutions, Inc.
Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve. 2 09/19/2008 Ascent Healthcare Solutions, Inc.
VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve. 2 09/19/2008 Ascent Healthcare Solutions, Inc.
Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve. 2 09/19/2008 Ascent Healthcare Solutions, Inc.
Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 86... 2 09/16/2008 Philips Medical Systems
Innova 2000's principle system components include a C-arm, image acquisition, processing and archivi... 2 09/16/2008 GE Healthcare
Panda® iRes and Giraffe® Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, M... 2 09/11/2008 Datex Ohmeda, Inc. dba GE Healthcare
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. The Defini... 2 09/04/2008 GE Healthcare
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definiu... 2 09/04/2008 GE Healthcare
Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kit... 2 09/03/2008 Galil Medical
OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, O... 2 09/01/2008 OEC Medical Systems, Inc
OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy Syst... 2 09/01/2008 OEC Medical Systems, Inc
Corometrics® MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. ... 2 08/26/2008 Datex Ohmeda, Inc. dba GE Healthcare
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD,... 2 08/24/2008 Baxter Healthcare Corp.
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ing... 2 08/19/2008 Baxa Corporation
Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingre... 2 08/19/2008 Baxa Corporation
Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCa... 2 08/06/2008 Hospira Inc.
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Res... 2 07/24/2008 Medtronic Perfusion Systems
Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascular Cardiop... 2 07/24/2008 Medtronic Perfusion Systems
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Sur... 2 07/24/2008 Medtronic Perfusion Systems
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model... 2 04/24/2008 Respironics, Inc.
Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Ma... 2 03/25/2008 Siemens Medical Solutions USA, Inc
Siemens Magnetom Harmony syngo. Model Number: 7106714, Siemens Medical Solutions USA, Malvern PA, 19... 2 03/25/2008 Siemens Medical Solutions USA, Inc
Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19... 2 03/25/2008 Siemens Medical Solutions USA, Inc
Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167... 2 03/08/2008 Chattem Inc
Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the follow... 2 02/13/2008 Abbott Spine
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Li... 2 11/27/2007 Medtronic Navigation, Inc
Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2) 2 11/10/2007 Philips Medical Systems North America Co. Phillips
GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Supe... 2 11/10/2007 GE OEC Medical Systems, Inc
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Val... 3 10/02/2007 Heraeus Kulzer Inc., Dental Products Division
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml... 3 10/02/2007 Heraeus Kulzer Inc., Dental Products Division
OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare... 2 09/28/2007 GE OEC Medical Systems, Inc
OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt... 2 09/28/2007 GE OEC Medical Systems, Inc
Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Engle... 1 09/27/2007 Baxa Corporation
Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and... 2 08/18/2007 Arizant Healthcare, Inc
Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and... 2 08/18/2007 Arizant Healthcare, Inc
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. 2 07/12/2007 GE OEC Medical Systems, Inc
GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. 2 07/12/2007 GE OEC Medical Systems, Inc
Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture wit... 2 05/24/2007 C P Medical
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4... 2 04/26/2007 Smiths Medical MD, Inc.
Aspyra, Inc. CyberMED Version 2.1 Pharmacy Software 2 03/31/2007 Aspyra, Inc.
Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Pa... 2 03/29/2007 Intuitive Surgical, Inc.
OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, 2 03/22/2007 GE OEC Medical Systems, Inc
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C t... 3 02/17/2007 EMD Chemicals Inc
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aero... 3 02/17/2007 EMD Chemicals Inc
Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Ele... 2 01/11/2007 Fisher & Paykel Healthcare Ltd
BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This devic... 2 12/19/2006 Smiths Medical PM, Inc.
First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid items, all... 2 11/02/2006 First Aid Only Inc
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US 2 10/12/2006 Haemonetics Corporation
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical S... 2 10/03/2006 GE OEC Medical Systems, Inc
GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. 2 09/30/2006 GE OEC Medical Systems, Inc
GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. 2 09/30/2006 GE OEC Medical Systems, Inc
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system. 2 09/30/2006 GE OEC Medical Systems,Inc
Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cov... 2 06/17/2006 Abbott Spine
Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter... 2 05/25/2006 Instituto Grifols, S.A.
Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlle... 1 05/02/2006 Respironics California Inc
Storz Documentation Cart with Articulating Arm, Model Number 9601F 2 04/19/2006 Karl Storz Endoscopy America Inc
Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC de... 2 02/04/2006 Omron Healthcare, Inc.
Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30 2 01/24/2006 Instrumentation Industries Inc
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator... 2 01/06/2006 Respironics California Inc
Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M... 2 12/23/2005 Boston Scientific Scimed
Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. ... 2 12/23/2005 Boston Scientific Scimed
Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Ve... 1 12/20/2005 Boston Scientific
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices pa... 2 11/18/2005 Cardinal Health
Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3... 2 10/25/2005 Medrad Inc

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