10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REMEL
FDA UDI
REMEL, INC.·00848838007194·GN Broth (5ml) 100/PK
OPUS 10 DENTAL DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMS SLING FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code KGS·June 12, 2008
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 1, 2011
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016