21 results · 31ms · Sources: EU EUDAMED, US FDA

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OMNI-JUG

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

OsteoMed

FDA UDI
OSTEOMED LLC·00845694041089·ExtremiFuse Dual Cannulated Driver Handle

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192169·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...

Instrument Case

FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·September 2, 2011

SurgTech Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

TEM 3000 HEAD COIL

FDA 510(k)
FDA Class 2 ·Radiology

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC VASCULAR IRELAND·Product code MIH·September 2, 2011

ANEURX STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 3, 2011

ANEURX STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 3, 2011

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 2, 2011

ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 2, 2011

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·September 2, 2011

PROCEDURAL STRETCHER

FDA Adverse Event
Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·May 13, 2014

CARELINK PROGRAMMER 2090X

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code NVZ·February 9, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 4, 2011

RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

STEALTH 32 LHOOK LAP ELEC PKG

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

STEALTH 32 LHOOK LAP ELEC PKG

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 8, 2017