21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MobiliT Cup
FDA 510(k)
FDA Class 2
·Orthopedic
Life Instruments
FDA UDI
Life Instrument Corporation·M930719183100·Triangle Endplate Curette 18" 11mm
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
FDA 510(k)
FDA Class 2
·Hematology
MX-7000 MICROXEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831030·18" Str Dlb Sided Triangular Endplate Curette
Life Instruments
FDA UDI
Life Instrument Corporation·M93071918310B10·Triangular Endplate Scraper 18"
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831130·Triangular Curette 11mm 18.5" Fwd Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M93071918310B20·Triangular Endplate Scraper 18"
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831010·Triangle Endplate Curette 11mm 13"WL-5" Handle
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831020·18" Triangular Endplate Scraper 13mm Str.
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831120·18" Triangular Endplate Scraper 13mm Ang.
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831310·18" Dbl Sd Triangle Endplate Curette 45° fwd w/...
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191831210·18" Dbl Sided Triangular Endplate Curette Fwd 1...
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 15, 2022
ACCENT DR RF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 22, 2011
BINAXNOW COVID-19 AG SELF TEST OTC
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 3, 2022
BINAXNOW COVID-19 AG SELF TEST OTC
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 3, 2022
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