9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VixWin Platinum
FDA 510(k)
FDA Class 2
·Radiology
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581463·Split Tube Retractor Ø26x30 mm
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
FDA 510(k)
FDA Class 2
·Orthopedic
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
TOTAL ASR FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 28, 2021
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
FDA Enforcement
Class II
·Terminated·Cardiac Assist, Inc·February 19, 2020