14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELITTECH CLINICAL SYSTEMS ALP IFCC SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PATCHASSIST LARGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
FDA 510(k)
FDA Class 2
·Anesthesiology
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2025
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
NEXGEN PROVISIONAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2011
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·May 8, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·August 11, 2008
BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·March 23, 2016
VANGUARD MONO FINNED STM TIB 71X14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·December 9, 2024
VANGUARD ROCC TIB BRG UHMWPE 60X10MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025
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 L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025