9 results
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36ms
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Sources: EU EUDAMED, US FDA
EYEGLASSES FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
FDA Recall
Terminated
·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004
TIE-IN TRAPEZIUM
FDA 510(k)
FDA Class 2
·Orthopedic
CAMBER SPINE COVERIS CERVICAL CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
VENACURE 65CM FIBER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code GEX·October 1, 2007
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·January 29, 2013
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021