15 results · 36ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DUO-DENT DENTAL IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

AEQ REV II GLENOID BASEPLATE DIA 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

PROCISE MAX

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code GEI·April 8, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 4, 2011

2017865-2008-01372

FDA Adverse Event
Malfunction ·Product code DTB·May 27, 2008

AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

D.4,5MM COMPRESSION SCREW L.32MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

D.4,5MM COMPRESSION SCREW L.23MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

Instructions For Use document of the GPS Trackers.

FDA Enforcement
Class II ·Terminated·Blue Ortho·November 4, 2020

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012