17 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Back 3 COLOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982153722·4.5MM CORTEX SCREW 90MM
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514940·
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003114·Cervical PEEK, 6°, 14mm W x 12mm D x 9mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003138·Cervical PEEK, 10°, 14mm W x 12mm D x 9mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003121·Cervical PEEK, 0°, 12x14x9
ENDIUS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Impulse AM Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 28MM
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·July 26, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 30, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 20, 2011
LINEAR HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·July 3, 2013
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021