13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284621·BECKMAN-WEITLANER RETRACTOR 9 1/2" 3X4 BLUNT
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920935·
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209109548·KIT, SIRK - CUSTOM
ZERO Profile Interlocking Cortex Screw, 3.5mm x 44mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118116978·Intramedullary fixation screw
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575384044·Modular Stem,with femoral traper and 6 mm noses
PULSE OXIMETER ADAPTER CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
Agem Ag Mesh Dressing with Silver
FDA 510(k)
FDA Unclassified
·Unknown
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·Product code NFA·October 4, 2010
S8-3T TRANSDUCER
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IYO·November 15, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021