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

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HEMASORBPLUS Resorbable Hemostatic Bone Putty

FDA 510(k)
FDA Unclassified ·Unknown

Sklar®

FDA UDI
SKLAR CORPORATION·10649111050565·SKLHN SKLT METZ SCISS CVD 7"

Zavation

FDA UDI
Zavation LLC·00842166112438·Z-Link Lumbar Spacer 15eg 33mmx17

Zavation

FDA UDI
Zavation LLC·00842166177451·Z-Link Lumbar Sizer 15 deg, 33mm x 17

RESUSCITATION UNIT 105

FDA 510(k)
FDA Class 2 ·Anesthesiology

LIFECHOICE OXYGEN CONCENTRATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·July 22, 2015

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 16, 2018

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 18, 2015

PENUMBRA SYSTEM JETD REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·May 8, 2019

CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·October 30, 2015

PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·June 14, 2015

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 26, 2015

DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·June 8, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·October 8, 2014

PROLIEVE TEMPERATURE MONITOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 21, 2008

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 9, 2015

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·September 9, 2015