21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·00885554012750·MTO ARTHROSCOPE 4.0 X 45 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133609·LATERAL,BONE GRAFT INSERTER,PLUNGER
PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023
PASS LP SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
FDA 510(k)
FDA Class 2
·Cardiovascular
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·April 9, 2026
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2025
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·July 11, 2025
MYSPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·September 27, 2024
EXTENSION, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 10, 2011
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code LIT·October 29, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
CASH 14 PLAT COIL 4MMX6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
PEDICLE SCREW MUST MC SCREW Ø6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·December 21, 2022
GALAXY G3 MINI 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
"E-LINE" URETERORENOSCOPE
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code FGB·April 10, 2020
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