11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983048·posteriors; shade B2; size XL; upper jaw
NEORAY DR 2520 DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Quantisal II Oral Fluid Collection Device
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NexGen®
FDA UDI
Zimmer, Inc.·00889024218369·
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 4, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·August 6, 2014
SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·June 12, 2025
SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·June 12, 2025
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024