8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYERSON'S PERMASOFT SOFT RELINE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088750·Paddle Distractor, Long, 15mm
Iconix Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
GOBED+
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