17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUVENA VAGINAL MOISTURIZER & LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741622350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674162235060·
Bernafon
FDA UDI
Bernafon AG·05711584058831·SU7 P, VC PS SABE/MSIL SUITE 7
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1622350·16mm H x 22mm W x 35mm L x 0 degrees XLIF
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788022899·22g RW x 3.5" Blunt Nerve Block Needle
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16223580·16mm H x 22mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L162235120·16mm H x 22mm W x 35mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X162235120·16mm H x 22mm W x 35mm L x 12 degrees XLIF
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122285·KWire .062x9" (1.6x225mm)
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN DEPUY LCS STD+ CRUCIFORM PATELLA PLASTIC BEARING
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 7, 2011
KARL STORZ
FDA Adverse Event
Malfunction
·KARL STORZ IMAGING·Product code FWF·April 29, 2013
CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·September 3, 2008
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024