17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACCUTIP COVER
FDA 510(k)
FDA Class 2
·Ophthalmic
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
FDA 510(k)
FDA Unclassified
·Unknown
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
PROMUS ELEMENT ?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 29, 2013
LTV
FDA Adverse Event
Injury
·CAREFUSION 203, INC·Product code CBK·June 8, 2011
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·September 25, 2014
CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·November 2, 2021
POLARIS CURVED ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
POLARIS CURVED ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026