7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VANTAGE, FOR ADAC GAMMA CAMERAS
FDA 510(k)
FDA Class 2
·Radiology
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
FDA 510(k)
FDA Class 2
·Radiology
MINIARS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 5, 2013
ETS-FLEX - ENDOSCOPIC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 3, 2011
BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EQJ·July 18, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021