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U.S. Department of Health and Human Services

Medical Device Recalls
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Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ559... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood o... 1 12/07/2023 Maquet Medical Systems USA
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus® Four-Lumen CVC, REF CDC-42854- PC... 1 10/05/2023 ARROW INTERNATIONAL Inc.
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VP... 1 10/05/2023 ARROW INTERNATIONAL Inc.
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS... 1 10/05/2023 ARROW INTERNATIONAL Inc.
Oxylog 3000 Plus emergency and transport ventilator 1 07/08/2023 Draeger Medical, Inc.
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ... 1 06/08/2023 BearCare, Inc.
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannul... 1 04/19/2023 Covidien
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software... 1 12/22/2021 Medtronic Navigation, Inc.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Applic... 1 10/14/2021 Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Appl... 1 10/14/2021 Abbott Molecular, Inc.
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, S... 1 06/11/2019 Edwards Lifesciences, LLC
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is... 1 03/28/2019 Maquet Cardiovascular Us Sales, Llc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrill... 1 02/26/2019 Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) i... 1 02/26/2019 Physio-Control Inc
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Gui... 1 12/29/2018 Medtronic Navigation, Inc.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor ... 1 01/11/2018 Physio-Control, Inc.
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0... 1 08/26/2017 Spectranetics Corporation
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family ... 1 04/10/2017 Newport Medical Instruments Inc
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 30... 1 08/04/2016 Draeger Medical, Inc.
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SF... 1 05/16/2016 Monteris Medical Corp
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume cont... 1 02/03/2016 Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numb... 1 02/03/2016 Draeger Medical, Inc.
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient ... 1 01/11/2016 Thornhill Research Inc
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electri... 1 01/11/2016 Thornhill Research Inc
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological mo... 1 08/26/2015 Ethicon Endo-Surgery Inc
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended fo... 1 07/09/2015 Covidien LP (formerly Nellcor Puritan Bennett Inc.)
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Ca... 1 03/02/2015 Boston Scientific Corp
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT50... 1 07/03/2014 Ventlab LLC
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT... 1 04/14/2014 Newport Medical Instruments Inc
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 1 04/10/2014 Draeger Medical Systems, Inc.
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitat... 1 02/25/2014 GE Healthcare, LLC
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed a... 1 10/01/2013 H & H Associates
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan® Syne... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan®... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan® Synergies plus... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan® Synergies plus... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan® Synergies ... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan® Synergies plus® Pane... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan® Synergies plus® Panels... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan® Synergies plus® P... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan® Synergies plus® Panels &... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan® Synergies plus® Panels... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan® Synergies plus®... 1 09/11/2013 Siemens Healthcare Diagnostics, Inc.
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Ve... 1 08/07/2013 Cordis Corporation
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [... 1 02/08/2013 GE Healthcare, LLC
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator,... 1 02/08/2013 GE Healthcare, LLC
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, ... 1 11/01/2012 Ventlab Corporation
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
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 88... 1 07/24/2012 GE OEC Medical Systems, Inc
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-st... 1 05/24/2012 Pharmaceutical Innovations, Inc.
Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-ste... 1 05/24/2012 Pharmaceutical Innovations, Inc.
Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Pow... 1 02/27/2012 Cardiac Science Corporation
Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp. 1 04/01/2011 Xoft Inc.
Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system con... 1 02/04/2011 Arstasis, Inc
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventil... 1 09/08/2010 Westmed Inc
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventil... 1 09/08/2010 Westmed Inc
Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respec... 1 04/27/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model require... 1 03/04/2010 Cardiac Science Corporation
NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires the user ... 1 03/04/2010 Cardiac Science Corporation
NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to... 1 03/04/2010 Cardiac Science Corporation
GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user ... 1 03/04/2010 Cardiac Science Corporation
GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user ... 1 03/04/2010 Cardiac Science Corporation
Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requires the u... 1 03/04/2010 Cardiac Science Corporation
Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the u... 1 03/04/2010 Cardiac Science Corporation
Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requires the u... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does ... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requ... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic model requir... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requir... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requir... 1 03/04/2010 Cardiac Science Corporation
Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic model does ... 1 03/04/2010 Cardiac Science Corporation
EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STER... 1 11/06/2009 Edwards Lifesciences Research Medical, Inc.
EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm... 1 11/06/2009 Edwards Lifesciences Research Medical, Inc.
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID... 1 11/04/2009 Unomedical
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #... 1 11/04/2009 Unomedical
Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID... 1 11/04/2009 Unomedical
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: ... 1 11/04/2009 Unomedical
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID... 1 11/04/2009 Unomedical
Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID... 1 11/04/2009 Unomedical
Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. Packa... 1 11/04/2009 Unomedical
Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Produ... 1 11/04/2009 Unomedical
Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergree... 1 11/04/2009 Unomedical
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ... 1 11/04/2009 Unomedical
Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer. 1 11/03/2008 VIBE Technologies
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defi... 1 09/16/2008 Physio Control, Inc.
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an a... 2 03/19/2024 Sarnova HC, Llc
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an... 2 03/19/2024 Sarnova HC, Llc
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU... 2 02/29/2024 Acumed LLC
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table 2 01/13/2024 Oakworks Inc
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultr... 2 01/13/2024 Oakworks Inc
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Sp... 2 01/13/2024 Oakworks Inc
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultr... 2 01/13/2024 Oakworks Inc
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD 2 01/03/2024 Covidien
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation T... 2 12/01/2023 Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sy... 2 12/01/2023 Elekta, Inc.
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radio... 2 11/08/2023 Philips North America Llc
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. 2 11/03/2023 B. Braun Medical, Inc.
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular 2 09/15/2023 ARROW INTERNATIONAL Inc.
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-V... 2 09/15/2023 ARROW INTERNATIONAL Inc.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG las... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG ... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared las... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared las... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits H... 2 07/21/2023 Boston Scientific Corporation
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG lase... 2 07/21/2023 Boston Scientific Corporation
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH R... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURG... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANG... 2 07/03/2023 DeRoyal Industries Inc
Exactech Ergo Impactor Handle, Catalog #321-09-05. 2 06/30/2023 Exactech, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; ... 2 05/30/2023 Elekta, Inc.
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which ... 2 04/18/2023 Boston Scientific Corporation
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitori... 2 04/04/2023 Moberg Research, Inc.
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-eme... 2 03/15/2023 Stryker Medical Division of Stryker Corporation
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Pla... 2 03/14/2023 Securitas Healthcare LLC
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01 2 03/01/2023 Unetixs Vascular, Inc.
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (S... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Materi... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Numb... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13 2 12/15/2022 DeRoyal Industries Inc
DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 2 12/15/2022 DeRoyal Industries Inc
DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 2 12/15/2022 DeRoyal Industries Inc
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbona... 2 07/12/2022 Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbona... 2 07/12/2022 Fresenius Medical Care Holdings, Inc.
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an e... 2 06/23/2022 Maquet Cardiovascular, LLC
Reliance Synergy Washer/Disinfector 2 06/09/2022 Steris Corporation
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adh... 2 06/09/2022 Medminder Systems, Inc.
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS 2 06/06/2022 Oakworks Inc
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 2 06/06/2022 Oakworks Inc
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 2 05/31/2022 Intuitive Surgical, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD® System Emergency Re... 2 05/17/2022 Heartware, Inc.
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi... 2 05/17/2022 Medtronic Inc
Voalte Nurse Call System provides a comprehensive communication and information system that place... 2 05/13/2022 Baxter Healthcare Corporation
NaviCare Nurse Call System provides a comprehensive communication and information system that pla... 2 05/13/2022 Baxter Healthcare Corporation
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #... 2 05/11/2022 Certified Safety Mfg Inc
Senior Living Arial Emergency and Nurse Call Systems 2 01/14/2022 Stanley Security Solutions Inc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration st... 2 01/10/2022 Philips North America Llc
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, ster... 2 10/19/2021 Bard Peripheral Vascular Inc
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accele... 2 10/14/2021 Elekta, Inc.
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 ... 2 09/15/2021 Quidel Corporation
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and d... 2 09/03/2021 Versea Diagnostics LLC
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2,... 2 09/03/2021 Versea Diagnostics LLC
Merge Hemo, Software packages 10.2, 10.3, and 10.4 2 08/28/2021 Merge Healthcare, Inc.
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic... 2 08/10/2021 Covidien Llc
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Ster... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with t... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg® MR I... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic T... 2 04/16/2021 AZURE BIOTECH INC
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to... 2 03/19/2021 CAIRE DIAGNOSTICS INC
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunod... 2 03/17/2021 Ortho-Clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Rea... 2 03/17/2021 Ortho-Clinical Diagnostics, Inc.
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needl... 2 03/16/2021 Merit Medical Systems, Inc.
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needl... 2 03/16/2021 Merit Medical Systems, Inc.
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV... 2 01/12/2021 VISBY MEDICAL INC
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr intro... 2 12/23/2020 Prytime Medical Devices, Inc.
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Mad... 2 12/04/2020 Shimadzu Medical Systems
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA... 2 11/13/2020 Ortho Clinical Diagnostics Inc
Merge LIS 2 10/23/2020 Merge Healthcare, Inc.
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical... 2 10/21/2020 Bien-Air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Us... 2 10/21/2020 Bien-Air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert elec... 2 10/21/2020 Bien-Air Surgery Sa
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as foll... 2 09/25/2020 North American Rescue LLC.
Merge PACS 2 09/09/2020 Merge Healthcare, Inc.
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect o... 2 09/02/2020 Siemens Medical Solutions USA, Inc.
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Produ... 2 09/02/2020 Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for per... 2 09/02/2020 Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Produc... 2 09/02/2020 Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for per... 2 09/02/2020 Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for pe... 2 09/02/2020 Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Pr... 2 09/02/2020 Stimwave Technologies Inc
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distrib... 2 08/27/2020 Siemens Medical Solutions USA, Inc.
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during di... 2 08/27/2020 Ge Healthcare
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17... 2 08/24/2020 Klarity Medical Products LLC
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COV... 2 08/14/2020 Precision Valve & Automation,Inc
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery... 2 08/14/2020 Philips North America, LLC
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the... 2 08/14/2020 Philips North America, LLC
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in... 2 08/14/2020 Philips North America, LLC
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan ... 2 08/12/2020 HF Acquisition Co., LLC
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Nar... 2 08/12/2020 HF Acquisition Co., LLC
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narc... 2 08/12/2020 HF Acquisition Co., LLC
HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC,... 2 08/12/2020 HF Acquisition Co., LLC
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians... 2 08/10/2020 HF Acquisition Co. LLC
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033... 2 08/07/2020 Ortho Clinical Diagnostics
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750... 2 08/07/2020 Ortho Clinical Diagnostics
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviol... 2 07/04/2020 Ra Medical Systems, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Worksta... 2 06/19/2020 Merge Healthcare, Inc.
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exam... 2 06/16/2020 Siemens Medical Solutions USA, Inc
Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPA... 2 06/11/2020 Physio-Control, Inc.
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibri... 2 06/11/2020 Physio-Control, Inc.
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D 2 05/09/2020 Becton Dickinson & Company
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the ... 2 04/29/2020 Philips North America, LLC
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112... 2 04/23/2020 Acutus Medical Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, ... 2 04/07/2020 Siemens Medical Solutions USA, Inc
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.0... 2 03/31/2020 Philips North America, LLC
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. sc... 2 03/25/2020 Skytron, Div. The KMW Group, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospital... 2 02/20/2020 Siemens Medical Solutions USA, Inc
Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-00... 2 12/16/2019 Teleflex Medical
Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-00... 2 12/16/2019 Teleflex Medical
Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-00... 2 12/16/2019 Teleflex Medical
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the foll... 2 11/26/2019 Boston Scientific Corporation
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the followin... 2 11/26/2019 Boston Scientific Corporation
Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1... 2 11/21/2019 Applied Medical Resources Corp
Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system inten... 2 11/14/2019 Galil Medical, Inc.
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B) 2 11/08/2019 Basic Reset Inc.
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is a... 2 11/06/2019 Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is a... 2 11/06/2019 Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is a... 2 11/06/2019 Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is a... 2 11/06/2019 Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is a... 2 11/06/2019 Western / Scott Fetzer Company
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM... 2 10/31/2019 POM Medical LLC
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, ... 2 10/29/2019 Hycor Biomedical LLC
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equ... 2 10/21/2019 Exactech, Inc.
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography ex... 2 10/18/2019 Siemens Medical Solutions USA, Inc
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightw... 2 09/06/2019 Philips North America, LLC
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly throug... 2 08/08/2019 Ra Medical Systems Inc
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 2 07/23/2019 Merge Healthcare, Inc.
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 2 07/23/2019 Merge Healthcare, Inc.
Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z 2 07/02/2019 Madison Polymeric Engineering
EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense... 2 06/26/2019 AtriCure, Inc.
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X... 2 05/08/2019 Siemens Medical Solutions USA, Inc
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The... 2 05/07/2019 Siemens Medical Solutions USA, Inc
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode... 2 05/03/2019 Siemens Medical Solutions USA, Inc
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), ... 2 04/27/2019 Philips Medical Systems Nederlands
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee ... 2 04/23/2019 Exactech, Inc.
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMU... 2 04/19/2019 Siemens Medical Solutions USA, Inc
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is i... 2 03/21/2019 Shimadzu Medical Systems Usa Com
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to ... 2 03/21/2019 Fujifilm Medical Systems U.S.A., Inc.
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut an... 2 03/18/2019 Covidien, PLC
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic... 2 02/28/2019 Madison Polymeric Engineering
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging S... 2 02/25/2019 Merge Healthcare, Inc.
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control o... 2 02/20/2019 Baxter Healthcare Corporation
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control ... 2 02/20/2019 Baxter Healthcare Corporation
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm 2 02/07/2019 Angiotech (Manan Medical Products, Inc.)
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usag... 2 01/11/2019 Volcano Corporation
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usag... 2 01/11/2019 Volcano Corporation
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This... 2 01/09/2019 Cardinal Health Inc.
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The... 2 10/24/2018 Terumo Cardiovascular Systems Corporation
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label ... 2 10/11/2018 Merge Healthcare, Inc.
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label ... 2 10/03/2018 Johnson & Johnson Surgical Vision Inc
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicat... 2 09/20/2018 Exactech, Inc.
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 2 08/17/2018 Philips Medical Systems Gmbh, DMC
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 2 08/17/2018 Philips Medical Systems Gmbh, DMC
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platf... 2 08/17/2018 Elekta, Inc.
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN... 2 08/14/2018 Nico Corp.
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide pos... 2 08/14/2018 Hamilton Medical AG
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ H... 2 08/08/2018 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from t... 2 07/02/2018 Philips Medical Systems (Cleveland) Inc
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machine... 2 06/19/2018 Draeger Medical, Inc.
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines... 2 06/19/2018 Draeger Medical, Inc.
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia mach... 2 06/19/2018 Draeger Medical, Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM121... 2 06/12/2018 St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, ... 2 06/12/2018 St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-c... 2 06/12/2018 St Jude Medical Inc.
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy 2 06/05/2018 Tosoh Bioscience Inc
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 2 05/30/2018 WRP Asia Pacific Sdn Bhd
Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Num... 2 05/18/2018 Madison Polymeric Engineering
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Syn... 2 05/16/2018 ConvaTec, Inc
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are... 2 05/15/2018 Visaris DOO
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are... 2 05/15/2018 Visaris DOO
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are i... 2 05/15/2018 Visaris DOO
IMMULITE ® 2000/IMMULITE ® 2000 XPi 3g Allergy specific IgE Universal Kit 2 05/04/2018 Siemens Healthcare Diagnostics, Inc.
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LO... 2 05/01/2018 Stryker Medical Division of Stryker Corporation
5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900... 2 05/01/2018 CooperSurgical, Inc.
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: T... 2 04/17/2018 Siemens Medical Solutions USA, Inc
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 5... 2 04/12/2018 Teleflex Medical Europe Ltd
First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM E... 2 04/11/2018 Certified Safety Mfg Inc
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an i... 2 04/05/2018 Phadia US Inc
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in v... 2 04/05/2018 Phadia US Inc
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser i... 2 03/29/2018 SIE AG, Surgical Instrument Engineering
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface o... 2 03/26/2018 Madison Polymeric Engineering
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard... 2 03/14/2018 Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+... 2 03/14/2018 Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard... 2 03/14/2018 Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow® CVC is indicated to prov... 2 03/14/2018 Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Featu... 2 03/14/2018 Arrow International Inc
ARROWg+ard Blue® Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow® CVC is indicated to pr... 2 03/14/2018 Arrow International Inc
ARROWg+ard Blue Product Usage: The Arrow® CVC is indicated to provide short-term (< 30 days) cen... 2 03/14/2018 Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow® CVC is indicated to prov... 2 03/14/2018 Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow® CVC is ... 2 03/14/2018 Arrow International Inc
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow® CVC is indicated to provi... 2 03/14/2018 Arrow International Inc
ARROWg+ard Blue® MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow® CVC is indic... 2 03/14/2018 Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow® CVC is i... 2 03/14/2018 Arrow International Inc
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS®... 2 03/14/2018 Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT® N-K FLX GSM POR FEM SZ 2 RT N-K FL... 2 03/14/2018 Zimmer Biomet, Inc.
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single ... 2 03/13/2018 ZOLL Medical Corporation
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administ... 2 03/09/2018 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Prod... 2 03/03/2018 Medtronic Neuromodulation
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are ... 2 03/01/2018 ZOLL Medical Corporation
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. I... 2 01/19/2018 Sorin Group Deutschland GmbH
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All... 2 01/18/2018 Exactech, Inc.
Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - ... 2 01/14/2018 Merge Healthcare, Inc.
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluo... 2 01/09/2018 Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoro... 2 01/09/2018 Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoro... 2 01/09/2018 Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoro... 2 01/09/2018 Orthoscan, Inc.
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. 2 12/13/2017 Elekta Inc
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distr... 2 11/16/2017 Siemens Medical Solutions USA, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distri... 2 11/16/2017 Siemens Medical Solutions USA, Inc.
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical ... 2 09/12/2017 Zimmer Biomet, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label ... 2 08/18/2017 Merge Healthcare, Inc.
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice... 2 08/16/2017 Baxter Healthcare Corporation
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Aut... 2 08/16/2017 Baxter Healthcare Corporation
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; M... 2 08/02/2017 Xintec Corp
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the M... 2 07/10/2017 Merge Healthcare, Inc.
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, manageme... 2 07/10/2017 Merge Healthcare, Inc.
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075),... 2 06/29/2017 Merge Healthcare, Inc.
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part... 2 06/29/2017 Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: ... 2 06/29/2017 Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hem... 2 06/29/2017 Merge Healthcare, Inc.
Merge OrthoPACS software. 2 06/22/2017 Merge Healthcare, Inc.
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 06/16/2017 Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed ... 2 06/15/2017 Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 06/15/2017 Merge Healthcare, Inc.
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard ... 2 06/06/2017 Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg... 2 06/06/2017 Arrow International Inc
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated ... 2 06/06/2017 Arrow International Inc
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps... 2 06/06/2017 Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The A... 2 06/06/2017 Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The A... 2 06/06/2017 Arrow International Inc
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard B... 2 06/06/2017 Arrow International Inc
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Bl... 2 06/06/2017 Arrow International Inc
Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Centr... 2 06/06/2017 Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter Th... 2 06/06/2017 Arrow International Inc
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated... 2 06/06/2017 Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter Th... 2 06/06/2017 Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard ... 2 06/06/2017 Arrow International Inc
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Bl... 2 06/06/2017 Arrow International Inc
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a comple... 2 05/25/2017 Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended ... 2 05/22/2017 Merge Healthcare, Inc.
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z 2 05/12/2017 Madison Polymeric Engineering
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit i... 2 05/02/2017 Merge Healthcare, Inc.
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This devic... 2 04/25/2017 Vortran Medical Technology 1, Inc
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesth... 2 04/25/2017 Vortran Medical Technology 1, Inc
Merge Eye Station and Merge Eye Care PACS. 2 04/15/2017 Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo m... 2 04/11/2017 Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Har... 2 04/05/2017 Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire,... 2 03/21/2017 Merge Healthcare, Inc.
Mevatron M2/Primus Mid-Energy PRIMUS HI 2 03/20/2017 Siemens Medical Solutions USA, Inc
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthc... 2 03/20/2017 Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. 2 03/20/2017 Merge Healthcare, Inc.
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless em... 2 03/20/2017 Stanley Security Solutions Inc
Merge Cardio software. 2 03/19/2017 Merge Healthcare, Inc.
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon A... 2 03/14/2017 Del Mar Reynolds Medical, Ltd.
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records... 2 03/14/2017 Merge Healthcare, Inc.
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant use... 2 03/14/2017 Terumo Cardiovascular Systems Corporation
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station ... 2 03/13/2017 Merge Healthcare, Inc.
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare... 2 03/10/2017 Merge Healthcare, Inc.
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the S... 2 03/09/2017 Siemens Medical Solutions USA, Inc
DR Systems Unity PACS software, now known as Merge Unity PACS 2 03/09/2017 Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare. 2 03/09/2017 Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. 2 03/08/2017 Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 03/03/2017 Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS i... 2 03/02/2017 Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. T... 2 02/23/2017 Merge Healthcare, Inc.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major compone... 2 02/15/2017 Merge Healthcare, Inc.
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 02/09/2017 Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 02/09/2017 Merge Healthcare, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medic... 2 02/07/2017 Physio-Control, Inc.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas ... 2 02/07/2017 Physio-Control, Inc.
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation R... 2 02/06/2017 Merge Healthcare, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patie... 2 01/24/2017 Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire,... 2 01/19/2017 Merge Healthcare, Inc.
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Ret... 2 01/12/2017 Merge Healthcare, Inc.
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed T... 2 01/11/2017 Philips Medical Systems (Cleveland) Inc
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-f... 2 01/09/2017 GE OEC Medical Systems, Inc
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film image... 2 01/09/2017 GE OEC Medical Systems, Inc
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endosc... 2 01/09/2017 Advanced Sterilization Products
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individual... 2 01/04/2017 Smith & Nephew, Inc.
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicat... 2 01/04/2017 Smith & Nephew, Inc.
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals... 2 01/04/2017 Smith & Nephew, Inc.
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patient... 2 01/03/2017 Infraredx, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS software. 2 12/30/2016 Merge Healthcare, Inc.
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 12/21/2016 Merge Healthcare, Inc.
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor an... 2 12/14/2016 Physio-Control, Inc.
LightMix® Zika rRT-PCR Test The LightMix® Zika rRT-PCR Test is a real-time RT-PCR test intended for... 2 12/13/2016 Roche Molecular Systems, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, tr... 2 12/09/2016 Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, tr... 2 12/09/2016 Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and markete... 2 12/08/2016 Merge Healthcare, Inc.
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application t... 2 12/05/2016 Merge Healthcare, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human pa... 2 11/28/2016 Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conju... 2 11/28/2016 Merge Healthcare, Inc.
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressu... 2 11/28/2016 Hamilton Medical, Inc.
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in ap... 2 11/28/2016 Spectranetics Corporation
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriev... 2 11/22/2016 AtriCure, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8,... 2 11/18/2016 Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is des... 2 11/17/2016 Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 11/17/2016 Merge Healthcare, Inc.
Merge LIS software. 2 11/11/2016 Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 10/19/2016 Merge Healthcare, Inc.
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radion... 2 10/08/2016 Siemens Medical Solutions USA, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the bod... 2 10/08/2016 Siemens Medical Solutions USA, Inc.
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in... 2 10/04/2016 Siemens Medical Solutions USA, Inc
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic ... 2 10/04/2016 Siemens Medical Solutions USA, Inc
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and m... 2 10/04/2016 Siemens Medical Solutions USA, Inc
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: ... 2 09/26/2016 Spiegelberg Gmbh & Co. KG
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information... 2 09/21/2016 Merge Healthcare, Inc.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code ... 2 09/20/2016 Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 77... 2 09/20/2016 Carefusion 2200 Inc
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 09/14/2016 Merge Healthcare, Inc.
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of ... 2 09/08/2016 Siemens Medical Solutions USA, Inc.
Merge RadSuite software. Radiological image processing system. 2 09/02/2016 Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image process... 2 09/01/2016 Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provid... 2 08/29/2016 Merge Healthcare, Inc.
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConn... 2 08/29/2016 Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 08/23/2016 Merge Healthcare, Inc.
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled ... 2 08/22/2016 Baxter Healthcare Corp.
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and info... 2 08/16/2016 Merge Healthcare, Inc.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic... 2 08/12/2016 Merge Healthcare, Inc.
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofre... 2 08/11/2016 Halyard Health, Inc
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was... 2 08/10/2016 Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intende... 2 08/08/2016 Merge Healthcare, Inc.
Merge HEMO software. 2 08/04/2016 Merge Healthcare, Inc.
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip... 2 08/03/2016 AccessClosure, Inc., A Cardinal Health Company
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2... 2 08/03/2016 B-K Medical A/S
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic wi... 2 08/02/2016 Medtronic Navigation, Inc.
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a ... 2 08/02/2016 Medtronic Navigation, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to ... 2 07/29/2016 Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge ... 2 07/29/2016 Merge Healthcare, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephe... 2 07/28/2016 Smith & Nephew, Inc.
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. 2 07/11/2016 Merge Healthcare, Inc.
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePAC... 2 07/08/2016 Merge Healthcare, Inc.
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product U... 2 07/06/2016 Arrow International Inc
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Fem... 2 07/05/2016 Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Pro... 2 07/05/2016 Exactech, Inc.
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive c... 2 06/20/2016 Immuno-Mycologics, Inc
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V... 2 06/15/2016 Physio-Control, Inc.
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer I... 2 06/01/2016 Ventlab LLC
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27... 2 05/31/2016 Skytron, Div. The KMW Group, Inc
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tra... 2 05/31/2016 Medscience Inc
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surger... 2 05/17/2016 Alcon Research, Ltd.
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, In... 2 05/03/2016 Biomerieux Inc
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing ... 2 04/05/2016 Therakos Inc
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobil... 2 03/31/2016 Siemens Medical Solutions USA, Inc
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-... 2 03/24/2016 Neurotherm, Inc.
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for ... 2 03/24/2016 Ambu Inc.
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 93... 2 03/09/2016 Cardiac Science Corporation
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & n... 2 02/25/2016 Bigwall Enterprises
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a s... 2 02/24/2016 EKOS Corporation
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Fl... 2 02/22/2016 Zimmer Biomet, Inc.
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, ... 2 02/22/2016 Zimmer Biomet, Inc.
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination ... 2 02/05/2016 Philips Electronics North America Corporation
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionucl... 2 01/21/2016 Siemens Medical Solutions USA, Inc.
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utiliz... 2 01/14/2016 Skytron, Div. The KMW Group, Inc
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Inva... 2 01/13/2016 CompView Medical, LLC
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator ... 2 01/12/2016 Mercury Enterprises, Inc. dba Mercury Medical
AMSCO® Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets... 2 01/06/2016 Steris Corporation
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Pr... 2 01/05/2016 Ultradent Products, Inc.
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4... 2 01/04/2016 Vidco, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) mo... 2 12/28/2015 Merge Healthcare, Inc.
Merge Cardio with software version 10.1 LA. 2 12/28/2015 Merge Healthcare, Inc.
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and ... 2 12/18/2015 Shimadzu Medical Systems
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medli... 2 12/16/2015 Bestmed, LLC
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CA... 2 12/02/2015 DeRoyal Industries Inc
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Therm... 2 12/01/2015 ConMed Corporation
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number... 2 11/05/2015 Pyng Medical Corporation
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the di... 2 11/04/2015 Siemens Medical Solutions USA, Inc.
Arthroscopic Energy 50® Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection... 2 11/03/2015 ConMed Corporation
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2... 2 10/27/2015 Siemens Medical Solutions USA, Inc
Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Di... 2 10/15/2015 DJO, LLC
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System. 2 10/01/2015 Lifeline Systems, Incorporated
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusio... 2 09/15/2015 Applied Medical Resources Corp
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal... 2 08/06/2015 Merge Healthcare, Inc.
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device... 2 07/20/2015 EKOS Corporation
Philips GoSafe Communicator 7000L Personal emergency response system. 2 07/06/2015 Lifeline Systems, Incorporated
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatom... 2 07/02/2015 Siemens Medical Solutions USA, Inc
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14... 2 06/26/2015 Varian Medical Systems, Inc. Oncology Systems
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as... 2 06/26/2015 Elekta, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Mater... 2 06/25/2015 Siemens Healthcare Diagnostics, Inc.
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for ar... 2 06/24/2015 Stryker Endoscopy
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm)... 2 06/11/2015 Edwards Lifesciences, LLC
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope ... 2 06/05/2015 Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR En... 2 06/05/2015 Advanced Sterilization Products
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules... 2 05/28/2015 GE Healthcare
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software... 2 05/28/2015 Optimedica Corporation
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max... 2 05/23/2015 Siemens Medical Solutions USA, Inc
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Usi... 2 05/23/2015 Siemens Medical Solutions USA, Inc
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). ... 2 04/23/2015 Abbott Medical Optics, Inc.
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intra... 2 04/02/2015 Nidek Inc
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides ... 2 03/19/2015 Siemens Medical Solutions USA, Inc.
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides i... 2 03/19/2015 Siemens Medical Solutions USA, Inc.
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Perso... 2 03/18/2015 Baxter Healthcare Corp.
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Ca... 2 03/13/2015 Bard Access Systems
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intend... 2 03/06/2015 Pivotal Health Solutions
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididu... 2 02/20/2015 Zimmer Gmbh
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impre... 2 02/05/2015 Siemens Medical Solutions USA, Inc
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation... 2 02/04/2015 Cardinal Health
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. ... 2 01/16/2015 Siemens Medical Solutions USA, Inc
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONC... 2 01/15/2015 Siemens Medical Solutions USA, Inc
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument softw... 2 01/12/2015 Phadia US Inc
e.cam -emission computed tomography system Used to detect or image the distribution of radionucli... 2 01/06/2015 Siemens Medical Solutions USA, Inc.

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