8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984019·anteriors; shade A1; mould R 76
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ALM OPERATING TABLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·February 28, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·January 14, 2011
INST OIL W/ FILTER, AL-II/III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·December 18, 2013
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