12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TECA TC2-64 TRANSCRANIAL DOPPLER
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501370·
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111634·Modular Stem 13mm x 75mm
TEMPTOUCH DERMAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SpiroThor
FDA 510(k)
FDA Class 2
·Anesthesiology
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
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·Product code KWA·November 29, 2012
SPACEMAKER PREPERITONEAL DIST BALLOON
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·September 22, 2010
ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code PHX·June 15, 2023
ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code PHX·June 15, 2023
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