45 results · 23ms · Sources: EU EUDAMED, US FDA

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CONSTELLATION VISION SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517635495·CoRoent Ant TLIF PEEK, 10x11x28mm 15°

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690123811·Tri Cut Tip- Tri-Drive pin

Spine Wave Instruments

FDA UDI
Spine Wave, Inc.·10840642154542·Cup Curette, Size 2, 30 Degree, Right

Zavation

FDA UDI
Zavation LLC·00197157009946·8.5mm TAP, NAVLOCK

LITETOUCH MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCU-CHEK GUIDE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020

ACCU-CHEK GUIDE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020

AS VEGA PS TIBIAL PLATEAU CEMENTED T3

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code JWH·April 4, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

QUICH CHECK ONE

FDA Adverse Event
Injury ·DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·December 26, 1996

QUADRA ASSURA CRT-D, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·September 6, 2011

AS COLUMBUS REV F FEMUR CEMENTED F5L

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code JWH·April 3, 2018

AS VEGA PS TIBIAL PLATEAU CEMENTED T3+

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code JWH·April 3, 2018

AS VEGA PS TIBIAL PLATEAU CEMENTED T2

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code JWH·April 3, 2018

AS COLUMBUS REV F TIB.OFFSET CEMENT.T5

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code JWH·April 3, 2018