27 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Double Flexible Tipped Wire Guides

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZenFlex

FDA UDI
Kerr Corporation·00195062029653·Rotary Files

NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT

FDA 510(k)
FDA Class 1 ·General Hospital

MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

RESOLUTE INTEGRITY RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·October 15, 2018

RESOLUTE INTEGRITY RX

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIQ·October 15, 2018

DR FOG TREATED SPONGE, STERILE

FDA Adverse Event
Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·August 6, 2019

OSSEOTITE TAPERED IMPLANT 4 X 8.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·October 18, 2024

OSSEOTITE TAPERED IMPLANT 4 X 8.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·October 18, 2024

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

LAMITRODE 44 60-CM LENGTH PADDLE LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025