11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T-Cuff
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BI-METRIC REVISION HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304003521·
Bi-Metric® Revision Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868261541·
MODIFIED COTTLE SPECULUM
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896018433·MODIFIED COTTLE SPECULUM TAPERED THIN WIDE LOW ...
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307575·
MICROPLEX COIL SYSTEM- COSMOS
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHREX ASPIRATE KIT
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MPRI·Product code LWS·June 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
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