8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
FDA 510(k)
FDA Class 2
·Neurology
ULTRASONIC SURGICAL UNIT
FDA 510(k)
FDA Class 2
·Dental
C3 ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·September 24, 2014
HI PWR DISPOSBL GRNDING PAD
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 24, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025