15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIV.A.C. Therapy Unit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304673830·
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18032568866131·GOTFRIED PC.C.P. SHAFT SCREW - 43 MM "PACK OF 5"
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304647916·
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18033509850691·GOTFRIED PC.C.P. SHAFT SCREW - 43 MM "PACK OF 5...
ONDEMAND3D
FDA 510(k)
FDA Class 2
·Radiology
DENOVISMED DENTAL IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·January 13, 2025
NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 20, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011
PNEUMOSURE INSUFFLATION TUBING
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code FCX·September 24, 2008
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2019
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026
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