9 results
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18ms
·
Sources: EU EUDAMED, US FDA
GEL-T CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149854·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.8mm DIA...
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
FDA 510(k)
FDA Class 2
·Neurology
MagVenture Accelerated TMS (aTMS) Therapy System
FDA 510(k)
FDA Class 2
·Neurology
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON MANUFACTURING, LTD.·Product code HQC·June 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·December 15, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024