11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570444·CoRoent Ant TLIF Ti, 13x12x34mm 0°
VISION XR
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975024930·Vision XR Duplicating Film 6"x12"Box of 100
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102473·CHANG-SEIBEL CHOPPER, RIGHT
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·August 18, 2011
WALKMED INFUSION TRITON FP INFUSION PUMP
FDA Adverse Event
Malfunction
·WALKMED INFUSION·Product code FRN·July 18, 2014
QUANTA SYSTEM
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 18, 2012
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020