8 results
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34ms
·
Sources: EU EUDAMED, US FDA
PULSE ELECTRIC TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
SeaSpine Spacer System - Ventura™ NanoMetalene®
FDA UDI
Seaspine Orthopedics Corporation·10889981050306·Ventura NM Trial, 9mm x 28mm x 16mm
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
FDA 510(k)
FDA Class 2
·Physical Medicine
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADAPTA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·January 29, 2013
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 21, 2010
SIGMA HP FEM NOTCH IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 15, 2014
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