16 results · 21ms · Sources: EU EUDAMED, 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