11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SKIN TECH. SURGI-STRIPS
FDA 510(k)
FDA Class 1
·General Hospital
ORICLE HEARING AID 2.0
FDA Adverse Event
Malfunction
·LIFETIME WELL LLC.·Product code QUH·June 25, 2025
BONESAVE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
TRUFREEZE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 27, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 15, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·September 5, 2010
HUMAPEN LUXURA HALF-DOSE PEN
FDA Adverse Event
Injury
·ELI LILLY AND COMPANY·Product code FMF·December 1, 2023
LOGIC KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 22, 2024
THREE PEG PATELLA 35MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 24, 2025
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015