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