16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOJET SOLENT DISTA THROMBECTOMY SET
FDA 510(k)
FDA Class 2
·Cardiovascular
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
CROSSPOINT TRANSACCESS CATHETER
FDA 510(k)
FDA Class 2
·Radiology
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
NEXGEN PROVISIONAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020
75MM SELECTABLE NEW TLC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 15, 2013
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 20, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·June 9, 2008
VANGUARD MONO FINNED STM TIB 71X14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·December 9, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
VANGUARD ROCC TIB BRG UHMWPE 60X10MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
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