22 results · 18ms · Sources: EU EUDAMED, US FDA

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CHEMMATE(TM) KAPPA

FDA 510(k)
FDA Class 2 ·Immunology

Cohere

FDA UDI
Nuvasive, Inc.·00195377096012·COHERE ALIF Bolt, Ø5x15mm Fixation

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690111641·Modular Stem 15mm x 100mm

OPTICS ONE

FDA UDI
MEDICAL TECHNIQUE, INC.·00815384021868·Leica/Wild Microscope Drape 54 x 150

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192626·Distal Reamer 15mm (Zimmer)

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938511·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939686·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937347·Percutaneous Transluminal Angioplasty Balloon C...

MANI NEEDLE & SUTURE PACK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

1717SGN / 1717SCN Digital Flat Panel X-ray Detector

FDA 510(k)
FDA Class 2 ·Radiology

DUAL MOBILITY ACETABULAR LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 16, 2017

MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·November 16, 2018

UNKNOWN HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 13, 2018

G7 DUAL MOBILITY LINER

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·February 14, 2018

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

GEMSTAR PM PMP

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·December 9, 2010

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 22, 2014

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Enforcement
Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

G7 OSSEOTI MULTIHOLE CUP

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 16, 2017

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Recall
Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025