7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIM E.COLI 0157:H7 LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
M2 COMPATIBLE MICROKERATOME BLADE
FDA 510(k)
FDA Class 1
·Ophthalmic
RUS
FDA 510(k)
FDA Class 2
·Radiology
SOFTCLIX® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 21, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024