8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
Stainless Steel Femoral Nailing System
FDA UDI
ORTHOFIX SRL·18032568862478·STERILE CANN. FEMORAL NAIL DIAMETER 12 MM LENG...
SYNGO VOLUME PERFUSION-CT NEURO
FDA 510(k)
FDA Class 2
·Radiology
ToxCO
FDA 510(k)
FDA Class 2
·Anesthesiology
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·February 21, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·Product code MGB·January 28, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024