9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S8 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22311424510·Stevens tenotomy scissors, curved blades with b...
ENDOWRIST ONE SUCTION/IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013
SYNVISC (HYLANG G-F 20) INJECTION
FDA Adverse Event
GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·March 21, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025