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