10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-STIM
FDA 510(k)
FDA Class 2
·Neurology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052024925·Arthroscopy - Pump P2
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154185306·INSTRUMENT TRAY, UPPER/MID-FACE
EXPD 4343P, EXPD 3643P
FDA 510(k)
FDA Class 2
·Radiology
MOST OPTIONS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ICY HOT SMART RELIEF TENS THERAPY
FDA Adverse Event
Injury
·CHATTEM, INC.·Product code NUH·June 11, 2014
ARTICUL/EZE BALL 28 +5 BR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. ? REG. # 8010379·Product code JDI·January 14, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 18, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024