9 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DFI-1000 AND DVS-475 IMAGING DEVICES
FDA 510(k)
FDA Class 2
·Radiology
G4 NiTi Lingual Wire .016 Large Upper
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199512610·
Elite® Buccal Tubes Direct Bond
FDA UDI
Ortho Organizers, Inc.·00190707074890·Elite®.022 SAA L7R NL MINI OPTI-MIM -25T DB
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
BIVONA MID-RANGE AIRE-CUF EXTRA LENGTH FIXED HYPERFLEX ADULT TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·December 13, 2010
TENDRIL STS
FDA Adverse Event
ST. JUDE MEDICAL, INC, CRMD·Product code DTS·July 22, 2014
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