11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOSCOPIC ANTI-FOG KIT, 100-302-00
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919931034·KM33-520
SeaSpine Spacer System - Ventura
FDA UDI
Seaspine Orthopedics Corporation·10889981089191·Ventura Implant/Trial Caddy, 9mm x 32mm
ZAVATION
FDA UDI
Zavation LLC·00842166190641·Polyaxial Reduction Screw 3.5x20
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837022051·3.5mm SOLSTICE® Smooth Shaft Poly Screw, 20mm
HAMMERLOCK 2
FDA 510(k)
FDA Class 2
·Orthopedic
BLUEPHASE
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX
FDA Adverse Event
Death
·MPRI·Product code DTB·January 29, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 20, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 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