14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OPTOS ADVANCE
FDA 510(k)
FDA Class 2
·Radiology
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021607·7450 V2 EXSM W/HG & 2700 NRBV
IMMCO DIAGNOSTICS
FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714000096·COMVI III Mouse Liver/Kidney/Stomach IFA Kit
SILMED NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
NEEDLE ECLIPSE 18X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·September 12, 2019
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·May 15, 2013
MAQUET CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTQ·September 17, 2014
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 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