18 results · 22ms · Sources: EU EUDAMED, US FDA

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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