11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Modified Thayer-Martin (MTM II) Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902215674·Plate Thayer-Martin Mod MTM II 20 Ea
Sklar®
FDA UDI
SKLAR CORPORATION·10649111008078·MAYO DISS SCISS DEL STR 6 3/4
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
FDA 510(k)
FDA Class 2
·Anesthesiology
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JAGTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 5, 2008
UNK - PDC IMPLANT
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·August 18, 2011
2520274-2013-04243
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·July 11, 2013
REAGENT RED BLOOD CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·September 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025