11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PEDIBAND CAT.#195-197
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008023140211·Rotary diamond instrument for dental application
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047583·
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CRYO-TOUCH II
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·July 28, 2021
BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 31, 2018
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 23, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 28, 2015