16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
FDA 510(k)
FDA Class 1
·General Hospital
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021268·Barricade Coil System (BCS) is intended for the...
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027213·3M™ Unitek™ Stainless Steel First Primary Molar...
SS Crown 8LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001270·
MyndMove
FDA UDI
MyndTec Inc·00692520001270·
MyndMove
FDA UDI
MyndTec Inc·06925209001273·
Revolution External Plating System
FDA UDI
Metalogix·00854641008099·General Tray
Conlin Molar Band
FDA UDI
Ortho Arch Company Inc·D90990012716·MOLAR BAND CONLIN RX UPPER RIGHT 42
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050726·.022/.045 UR6 CV CBT -14T 0A 14O
XBraid S
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277401182·Suture
METATARSAL DECOMPRESSION IMPLANT, MODEL 100
FDA 510(k)
FDA Class 2
·Orthopedic
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
FDA 510(k)
FDA Class 2
·Ophthalmic
LIBRA XP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code LGW·May 28, 2014
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·November 9, 2010
STARDRIVE(TM) SCREWDRIVER T15
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HXX·January 7, 2013