16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989054200·PRLS 2NDMOL B/T 12DEG -10T 022 WDX UR
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100837·FLIERINGA FIXATION RING 22MM
Bent Cup Inserter, Sz Grey AG
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057770·
HARMONIC 10CM COMBINATION HOOK BLADE
FDA 510(k)
FDA Unclassified
·Unknown
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·February 21, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·April 24, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 15, 2011
cobas c513 Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019
MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·July 8, 2020
MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·July 8, 2020
MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·July 8, 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