9 results · 19ms · Sources: EU EUDAMED, 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