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Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), c...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardi...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardi...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pu...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardi...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), ca...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), c...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329),...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), ...
|
1
|
12/15/2022
|
ARROW INTERNATIONAL Inc.
|
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-4...
|
1
|
12/10/2022
|
ARROW INTERNATIONAL Inc.
|
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; ...
|
1
|
12/10/2022
|
ARROW INTERNATIONAL Inc.
|
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
|
1
|
12/08/2022
|
Remel Inc
|
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
|
1
|
12/07/2022
|
DEWEI MEDICAL EQUIPMENT CO LTD
|
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
|
1
|
12/02/2022
|
Caire, Inc.
|
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
|
1
|
12/02/2022
|
Caire, Inc.
|
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
|
1
|
12/02/2022
|
Caire, Inc.
|
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
|
1
|
12/02/2022
|
Caire, Inc.
|
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating
Pad, PE-MtyBls-HeatPad-1...
|
1
|
11/23/2022
|
Whele LLC DBA Perch
|
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
|
1
|
11/23/2022
|
Whele LLC DBA Perch
|
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
|
1
|
11/23/2022
|
Whele LLC DBA Perch
|
18239: ASM Omnipod Dash PDM, insulin delivery system.
PT-000010: Assembly, Dash Final PDM U100, m...
|
1
|
11/15/2022
|
Insulet Corporation
|
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, P...
|
1
|
10/31/2022
|
Baxter Healthcare Corporation
|
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J...
|
1
|
10/31/2022
|
Baxter Healthcare Corporation
|
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product...
|
1
|
10/31/2022
|
Baxter Healthcare Corporation
|
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numb...
|
1
|
10/31/2022
|
Baxter Healthcare Corporation
|
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product...
|
1
|
10/31/2022
|
Baxter Healthcare Corporation
|
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap,...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medic...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical ...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection ...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. B...
|
1
|
10/14/2022
|
TELEFLEX LLC
|
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
|
1
|
10/08/2022
|
Jiangsu Well Biotech Co.,Ltd.
|
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004
version 5.2.0
|
1
|
10/06/2022
|
Fresenius Kabi USA, LLC
|
Therapy Mask 3100 NC/SP
|
1
|
09/30/2022
|
Philips Respironics, Inc.
|
DreamWisp Nasal Mask with Over the Nose Cushion
|
1
|
09/30/2022
|
Philips Respironics, Inc.
|
Wisp and Wisp Youth Nasal Mask
|
1
|
09/30/2022
|
Philips Respironics, Inc.
|
Philips Respironics DreamWear Full Face Mask
|
1
|
09/30/2022
|
Philips Respironics, Inc.
|
Philips Respironics Amara View Minimal Contact Full-Face Mask
|
1
|
09/30/2022
|
Philips Respironics, Inc.
|
TANDEM LIFE LivaNova LIFESPARC Controller;
Controller and Accessories Model 5900-0000;
Controller...
|
1
|
09/23/2022
|
Cardiac Assist, Inc
|
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line...
|
1
|
09/14/2022
|
Baxter Healthcare Corporation
|
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with ob...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructiv...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstr...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructiv...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for ...
|
1
|
09/09/2022
|
Philips Respironics, Inc.
|
NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229308
b) REF 8229307
c) REF 8229306
|
1
|
09/01/2022
|
Medtronic Xomed, Inc.
|
NIM CONTACT EMG Endotracheal Tube, Part Numbers:
a) REF 8229508
b) REF 8229507
c) REF 8229506
|
1
|
09/01/2022
|
Medtronic Xomed, Inc.
|
NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229307J
b) REF 8229308J
c) REF 8229306J
|
1
|
09/01/2022
|
Medtronic Xomed, Inc.
|
Maquet Critical Care AB/Getinge
Servo-u Ventilator System, Part Number 6694800
Servo-n Ventilator ...
|
1
|
08/22/2022
|
Getinge Usa Sales Inc
|
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
|
1
|
08/22/2022
|
Synapse Biomedical Inc
|
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
|
1
|
08/22/2022
|
Intera Oncology, Inc.
|
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
|
1
|
08/19/2022
|
Hamilton Medical AG
|
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
|
1
|
08/18/2022
|
Heartware, Inc.
|
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Co...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Co...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. ...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cro...
|
1
|
08/09/2022
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
|
1
|
08/08/2022
|
Haimen Shengbang Laboratory Equipment Co. Ltd.
|
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
|
1
|
08/08/2022
|
Haimen Shengbang Laboratory Equipment Co. Ltd.
|
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
|
1
|
08/08/2022
|
Haimen Shengbang Laboratory Equipment Co. Ltd.
|
SARS CoV 2 rapid antigen test kits packaged under the following brands:
Oral Rapid Test, Oral Rapid...
|
1
|
07/29/2022
|
North American Diagnostics
|
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1...
|
1
|
07/22/2022
|
Baxter Healthcare Corporation
|
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
|
1
|
07/22/2022
|
Integra LifeSciences Corp.
|
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver ...
|
1
|
07/22/2022
|
Bard Access Systems, Inc.
|
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 ...
|
1
|
07/19/2022
|
GE Healthcare, LLC
|
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic...
|
1
|
07/07/2022
|
Covidien Llc
|
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic he...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, a...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, aph...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemod...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acut...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, ap...
|
1
|
07/07/2022
|
Covidien Llc
|
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute a...
|
1
|
07/07/2022
|
Covidien Llc
|
Clean Catch Urine Kit NS 178489, AHMU58A
|
1
|
07/01/2022
|
American Contract Systems, Inc.
|
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184...
|
1
|
07/01/2022
|
American Contract Systems, Inc.
|
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entir...
|
1
|
06/23/2022
|
Getinge Usa Sales Inc
|
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire...
|
1
|
06/23/2022
|
Getinge Usa Sales Inc
|
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst...
|
1
|
06/21/2022
|
Medtronic Inc
|
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 40...
|
1
|
06/21/2022
|
Smiths Medical ASD Inc.
|
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-...
|
1
|
06/21/2022
|
Smiths Medical ASD Inc.
|
Drager SafeStar 55, Catalog No. MP01790
|
1
|
06/10/2022
|
Draeger Medical, Inc.
|
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr®om C...
|
1
|
06/06/2022
|
GE Healthcare, LLC
|
Back up batteries in Ventilators labeled as the following:
a. CARESCAPE R860 Ventilators (K142679)
b...
|
1
|
06/06/2022
|
GE Healthcare, LLC
|
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
|
1
|
06/03/2022
|
Medtronic Inc
|
In-Line ventilator adaptor
|
1
|
05/30/2022
|
Baxter Healthcare Corporation
|
In-Line ventilator adaptor
|
1
|
05/30/2022
|
Baxter Healthcare Corporation
|
Sara Plus Active Floor Lift
|
1
|
05/21/2022
|
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
|
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
|
1
|
05/19/2022
|
Abbott Vascular
|
iCast Covered Stent System
Product Code/Part Number:
85400
85401
85402
85403
85404
85405
8...
|
1
|
05/18/2022
|
Atrium Medical Corporation
|
Atrium Advanta V12 Covered Stent System (OUS only).
Product Code/Part Number:
85320 85321 85322 ...
|
1
|
05/18/2022
|
Atrium Medical Corporation
|
Avanos Cortrak 2 Enteral Access System (EAS)
|
1
|
05/13/2022
|
Avanos Medical, Inc.
|
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
|
1
|
05/12/2022
|
Woodside Acquisitions Inc.
|
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
|
1
|
05/12/2022
|
Woodside Acquisitions Inc.
|
Accula SARS-CoV-2 Test, REF: COV4100
|
1
|
05/06/2022
|
MESA BIOTECH, INC
|
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
|
1
|
05/03/2022
|
SML Distribution, LLC
|
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
|
1
|
04/27/2022
|
CELLTRION USA INC
|
Puritan Bennett 980 Series Ventilator
|
1
|
04/25/2022
|
Medtronic formerly Covidien
|
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 10536...
|
1
|
04/18/2022
|
Respironics California, LLC
|
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outs...
|
1
|
04/18/2022
|
Respironics California, LLC
|
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
|
1
|
04/18/2022
|
Respironics California, LLC
|
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replaceme...
|
1
|
04/18/2022
|
Medtronic Inc
|
Cub 2 Enclosed Bed Canopy System
|
1
|
04/14/2022
|
Sensory Medical Inc
|
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
The device is inten...
|
1
|
03/18/2022
|
Philips Respironics, Inc.
|
STANDARD Q COVID-19 Ag Home Test
STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immu...
|
1
|
03/16/2022
|
SD Biosensor, Inc.
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LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
|
1
|
03/10/2022
|
Lusys Laboratories, Inc.
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COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
|
1
|
03/10/2022
|
Lusys Laboratories, Inc.
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Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114...
|
1
|
03/10/2022
|
Lusys Laboratories, Inc.
|
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For ...
|
1
|
03/07/2022
|
ev3 Inc.
|
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For...
|
1
|
03/07/2022
|
ev3 Inc.
|
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
|
1
|
03/02/2022
|
CELLTRION USA INC
|
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
|
1
|
03/02/2022
|
CELLTRION USA INC
|
Philips Respironics V60 Ventilator Part Number 1053617
|
1
|
02/25/2022
|
Respironics California, LLC
|
Philips Respironics V60 Plus Ventilator Part Number 1138747
|
1
|
02/25/2022
|
Respironics California, LLC
|
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catal...
|
1
|
02/17/2022
|
BASE 10 GENETICS INC
|
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.
Th...
|
1
|
02/16/2022
|
Vyaire Medical
|
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containin...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)
The...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing ...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing c...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-4550...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing...
|
1
|
02/15/2022
|
TELEFLEX MEDICAL INC
|
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
|
1
|
02/09/2022
|
E25Bio, Inc.
|
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.
OXY-1 System cons...
|
1
|
02/03/2022
|
Abiomed, Inc.
|
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
|
1
|
01/29/2022
|
Baxter Healthcare Corporation
|
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
|
1
|
01/29/2022
|
Baxter Healthcare Corporation
|
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
|
1
|
01/29/2022
|
Empowered Diagnostics LLC
|
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
|
1
|
01/29/2022
|
Empowered Diagnostics LLC
|
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257
The Trilogy Evo ...
|
1
|
01/22/2022
|
Philips Respironics, Inc.
|
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea)
The Trilogy Evo ventilator ...
|
1
|
01/22/2022
|
Philips Respironics, Inc.
|
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6...
|
1
|
01/19/2022
|
ev3 Inc.
|
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, ...
|
1
|
01/19/2022
|
ev3 Inc.
|
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601
Component of the following systems:
Prod...
|
1
|
01/10/2022
|
Getinge Usa Sales Inc
|