14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ECG PATIENT MONITOR 302
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117520·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111658·Modular Stem 15mm x 150mm
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055231·MINI OVATION® Base Rx 022 UL/5-5 CS HK
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055241·MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
WECK-KREEM, CATALOG NO. 850-155
FDA 510(k)POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
NOVA Lite DAPI ANA Kit
FDA 510(k)
FDA Class 2
·Immunology
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
ABX MINOTROL 16
FDA Adverse Event
Other
·HORIBA MEDICAL·Product code GKZ·June 6, 2013
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 4, 2014
CVC KIT: 2-LUMEN 7FR X 2 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·November 21, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·September 22, 2010
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