327 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECICONTROL CLINCHEM MULTI 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108117·HA PEEK EVOS Straight, ,16mmx8mmx 30mm , FLAT ...
RHEAD
FDA UDI
Stryker GmbH·00886385024073·Stem Implant 6mm Collar,Size 3
ALL SILICONE FOLEY BALLOON CATHETER
FDA UDI
Sewoon Medical Co., Ltd.·08806369402521·2way/Translucent 30cc 16fr
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981298012·Closed Polyaxial Screwdriver, Cannulated, Navig...
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS INTEGRIS ALLURA
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
STRYKER CORPORATION·07613154410422·1.6mm Lindemann Drill Bit
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981308353·4-Blade Lateral Paddle Shaver, 16mm
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026004·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...
EchoLUTION Viral RNA/DNA Kit (16 x 96)
FDA UDI
BioEcho Life Sciences GmbH·04260759850226·
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 22, 2017
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·November 16, 2017
EVOLUT FX VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 15, 2025
rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
TCM CombiM Modules 903-111
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·November 18, 2015