18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
InFill Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·July 29, 2013
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023
NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 27, 2012
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025
REBAR
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code KRA·September 6, 2022
SOLITAIRE FR
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code NRY·September 6, 2022
UNKNOWN GII ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code JDR·October 24, 2019
UNKNOWN MINI ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·October 24, 2019
UNKNOWN PANALOK ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·October 24, 2019
SOLITAIRE FR
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code NRY·September 6, 2022
REBAR
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code KRA·September 6, 2022
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024