9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAUZE SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202798·Interbody, 9mm x 36mm x 9mm, 15 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194802·Interbody, 9mm x 36mm x 9mm, 15 deg
REFRACTROL-SP
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPACELABS MEDICAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 30, 2013
HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code JXG·December 13, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEATHCARE CORPORATION·Product code KDJ·July 15, 2014
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