12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICASE CONNECT, SURGICASE GUIDE
FDA 510(k)
FDA Class 2
·Orthopedic
NOBLEBOND
FDA UDI
ARGEN CORPORATION, THE·D818112389·Alloy other noble metal
2820 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750008599·2820B 3WAY MAN SLD 15/10.5 OD
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NAVIGATOR APPLICATIONS SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 14, 2013
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·September 23, 2014
LEG WRAP BLANKET
FDA Adverse Event
Injury
·STRYKER CORP DBA GAYMAR·Product code ILO·May 25, 2011
Allura Xper FD10; Model Number: 722003;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025