163 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IOPI MEDICAL LLC
FDA registration
IOPI MEDICAL LLC·1 product·🇺🇸 United States
IOPI®
FDA UDI
Iopi Medical LLC·10810091040284·IOPI® Report Generator software is an accessory...
IOPI®
FDA UDI
Iopi Medical LLC·10810091040239·The IOPI® Pro (Model 3.1) is used by healthcare...
IOPI®
FDA UDI
Iopi Medical LLC·10810091040055·IOPI® Report Generator software is an accessory...
IOPI®
FDA UDI
Iopi Medical LLC·10810091040246·The IOPI® Trainer (Model 3.2) is used to increa...
IOPI®
FDA UDI
Iopi Medical LLC·10810091040048·The IOPI® Trainer (Model 3.2) is used to increa...
IOPI®
FDA UDI
Iopi Medical LLC·10810091040031·The IOPI® Pro (Model 3.1) is used by healthcare...
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
FDA Recall
Terminated
·Medela Inc·Product code FMF·December 5, 2018
Norm-O-Temp model 111Z
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019
Norm-O-Temp model 111W
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations
FDA Recall
Terminated
·Apogee Medical, Inc·Product code OHR·March 24, 2011
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for general use.
FDA Recall
Terminated
·Cypress Medical Products LLC·Product code N/A·November 17, 2017
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
FDA Recall
Terminated
·Sun Med, LLC·Product code BTM·May 24, 2018
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
FDA Recall
Terminated
·Sun Med, LLC·Product code BTM·May 24, 2018