73 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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