83 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
FDA Recall
Terminated
·ConvaTec, Inc·Product code PQE·October 26, 2017
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·July 22, 2021
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
FDA Recall
Terminated
·Vapotherm, Inc.·Product code BTT·August 13, 2014
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Recall
Terminated
·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·September 8, 2021
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
FDA Enforcement
Class II
·Terminated·Vapotherm, Inc.·October 1, 2014
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
FDA Enforcement
Class II
·Terminated·Invacare Corporation·December 9, 2020
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Enforcement
Class II
·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·January 30, 2012
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
FDA Recall
Terminated
·Invacare Corporation·Product code CAW·October 30, 2020
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
FDA Recall
Terminated
·Vapotherm, Inc.·Product code BTT·August 13, 2014
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019