14 results · 22ms · 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.

T2 Alpha Tibia Nailing System, IMN Screws System

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517568243·CoRoent Ant TLIF PEEK, 9x13x30mm 8°

LEONE SPA

FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz

Orthos

FDA UDI
ORMCO CORPORATION·00889989030488·ORTHOS CM NITI ARCH16X22LOLG PK10

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

FDA 510(k)
FDA Class 2 ·Anesthesiology

AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

ISOFLEX S

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

RESTORE PRIME ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 13, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·December 18, 2018

HANDLE ACETABULAR PRESS

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

ACETABULAR PRESSURIZER SMALL

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017