7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MC3 Vascular Access Kit 21030
FDA 510(k)
FDA Class 2
·Cardiovascular
CLAMPFIX
FDA 510(k)
FDA Class 2
·Orthopedic
PATIENT INTERFACE 8253200 RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·February 25, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
AJUST ADJUSTABLE SINGLE INCISION SLING
FDA Adverse Event
Malfunction
·BARD SHANNON LIMITED·Product code PAH·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024