10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stryker Resorbable Fixation System
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Chloramphenicol - 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902307334·BD BBL™ Sensi-Disc™ Chloramphenicol 30 µg
Neonatal Miniature Clamp 30° 13cm
FDA UDI
Geister Medizintechnik GmbH·04057034062791·Neonatal Miniature Clamp 30° 13cm
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
INTERJECT INJECTION THERAPY NEEDLE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·October 28, 2008
UNKNOWN DEPUY SROM STEM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·September 1, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021