10 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293548·
SUBTALAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
FDA 510(k)
FDA Class 2
·Immunology
TAPERLOC POR FMRL 13.5X147
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Injury
·INVACARE TAYLOR STREET·Product code ITI·October 4, 2012
FORTIFY ASSURA DR
FDA Adverse Event
Injury
·ST. JUDE·Product code LWS·May 8, 2015
ACHIEVE ADVANCE MAPPING CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DRF·November 30, 2020
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
FDA Enforcement
Class II
·Completed·Smiths Medical ASD, Inc.·January 7, 2015
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025