10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MINISTICK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SKIN STAPLE EXTRACTOR
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
FDA 510(k)
FDA Class 1
·General Hospital
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 25, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·December 16, 2010
LCP(TM) DISTAL FEMUR PLATE 5 HOLES/156MM-LEFT
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·July 28, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 28, 2016
GS HIV-1/HIV-2 PLUS O EIA
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES·Product code MZF·June 10, 2009
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024