17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Latex Surgical Glove, Powder Free
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837081·Periosteal elevator, Obwegeser, 17.5cm, 6mm
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2021
NEUROMONITOR BASIC KIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·August 10, 2022
MBT CEM KEEL TIB TRAY SZ4
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·October 21, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? SINGAPORE·Product code FRN·August 4, 2011
MICRUSFRAME10 5MM X 17CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 2.5MM X 3.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 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