15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Geistlich Bio-Flow®
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982168696·WRIST FUSION PLATE 8 HOLES/STANDARD
Symmetry Craig
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482002230·Symmetry® Case, Craig Vertebral Biopsy
AMG PMP Infant
FDA 510(k)
FDA Class 2
·Cardiovascular
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ALARIS INFUSION SYSTEM
FDA Adverse Event
Other
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·November 21, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
OSS AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 9, 2021
OSS POLY TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 9, 2021
OSS TIBIAL POLY BEARING 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 9, 2021
OSS POLY LOCK PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 9, 2021
OSS REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·November 9, 2021
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023