11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOVIT FT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
SALVIN DENTAL SPECIALTIES FIXATION SCREW
FDA 510(k)
FDA Class 2
·Dental
ZYGOMA IMPLANT (IMMEDIATE FUNCTION)
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 4, 2022
AIR OSCILLATOR
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·October 14, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 14, 2013
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 24, 2011
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
FDA Enforcement
Class II
·Terminated·Meta C.G.M. Spa·June 9, 2021
JETSTREAM ATHERECTOMY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·July 18, 2025
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 7, 2022
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