11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PALMAZ XL TANSHEPATIC BILIARY STENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993091·anteriors; shade A3; mould UBS
KING DIAGNOSTICS GAMMA GT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 7, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·February 8, 2011
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015