11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
FDA 510(k)
FDA Class 2
·Neurology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265897·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508390·LAHEY SCISSORS CURVED 5 3/4"
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581470·Split Tube Retractor Ø26x40 mm
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KIT, RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·April 18, 2023
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
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
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