7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Asimov-MKS Imaging System
FDA 510(k)
FDA Class 2
·Radiology
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·April 26, 2013
TAP III
FDA Adverse Event
Malfunction
·AIRWAY MANAGEMENT INC.·Product code LRK·June 9, 2011
PFC SIGMA STAB INS SZ2 10MM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·October 22, 2014
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023