29 results · 20ms · 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.

SPEQ ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

LEONE SPA

FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0105050·Implant Inserter, 14-16mm, Sleeveless

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0105050·Inserter, Inline

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345027985·Lumbar Inserter, Rotate, 11-16H

SYNTHES TRANSLATING MAXILLARY DISTRACTOR

FDA 510(k)
FDA Class 2 ·Dental

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·April 21, 2010

INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 26, 2010

STABILIT INTRODUCER

FDA Adverse Event
Injury ·DFINE INC.·Product code ---·July 16, 2009

TENDRIL ST

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 2, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 15, 2014

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 26, 2011

ADULT DUAL HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 23, 2010

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·December 29, 2015

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·May 23, 2018