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

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CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS

FDA 510(k)
FDA Class 1 ·Pathology

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690111665·Modular Stem 15mm x 75mm

MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

AnapnoGuard 100 Respiratory Guard System

FDA 510(k)
FDA Class 2 ·Anesthesiology

PEDICLE SCREW TWO-STEP REDUCER ENHANCED

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·November 13, 2018

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 4, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 29, 2012

TARGET ADAPTER

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 22, 2010

PEDICLE SCREW TWO-STEP REDUCER ENHANCED

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·November 6, 2018

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