48 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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O-Mec 690 Series Laparoscopes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003158·270 micron Holmium Laser Fiber Cable, Reusable,...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113950·JOHN INTRALASIK CANNULA 27GA
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850958007777·3"x5" Foam, Case of 10
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850958007770·3"x5" Foam
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237902387·3"x5" Foam
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECTROSURGICAL ELECTRODE FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORNIER HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·DORNIER MEDTECH AMERICA, INC.·Product code GEX·April 2, 2021
WALLFLEX DUODENAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2011
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 2, 2013
DORNIER HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·DORNIER MEDTECH AMERICA, INC.·Product code GEX·June 22, 2016
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025