8 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MACROPORE PROTECTIVE SHEET
FDA 510(k)
FDA Class 2
·Dental
Masel
FDA UDI
Ortho Organizers, Inc.·00190707035358·.016 X .022 Lower Elastinol™ Drift-Free Natural...
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
FDA 510(k)
FDA Class 2
·Radiology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 28, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 4, 2011
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·July 7, 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