10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
FDA 510(k)
FDA Class 1
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125946·30-40 MV FOR MEN CLSC CALF STD NAVY VII
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
FDA 510(k)
FDA Class 2
·General Hospital
BRIGHTMATTER PLANNING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ENDOTAK ENDURANCE EZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 14, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 20, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·November 10, 2014
1.85MM X 16MM FLUTED ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
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