19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ImaCor Zura Handheld ZHH-010
FDA 510(k)
FDA Class 2
·Radiology
Uni-Flo
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005428·Uni-Flo™ Fenestrated Catheter – 5 inch (127mm),...
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
DeBakey-Derra Anastomosis Clamp 17cm
FDA UDI
Geister Medizintechnik GmbH·04057034056301·DeBakey-Derra Anastomosis Clamp 17cm
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996123082·LATERAL,SPACER 17,40X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120913·LATERAL,SPACER 17,60X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120906·LATERAL,SPACER 17,55X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120883·LATERAL,SPACER 17,45X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120920·LATERAL,SPACER 17,65X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120890·LATERAL,SPACER 17,50X8,6 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120876·LATERAL,SPACER 17,40X8,6 DEG
PBS, PBSW WITH CATIONS AND PHENOL RED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUICK SAMPLER HOLDER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUCIRA CHECK-IT COVID-19 TEST
FDA Adverse Event
Malfunction
·PFIZER, INC·Product code QJR·August 24, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 4, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FPA·December 4, 2025
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012