9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TIDI
FDA UDI
TIDI PRODUCTS, LLC·00618125114948·Sterilization Wrap
Lympha-Flow(LF1200)
FDA 510(k)
FDA Class 2
·Physical Medicine
VIX WIN PRO
FDA 510(k)
FDA Class 2
·Dental
WECKVISTA ACCESS BALLOON PORT 10MMX70MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GCJ·June 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 15, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015