10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Silk'n MODEL H5003 device
FDA 510(k)
FDA Class 2
·Physical Medicine
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258696065·
Femoral Cutting Block
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215063009·
REFORM PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NANOFUSE DBM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
UNKNOWN MESH PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code FTL·October 17, 2014
INPECO SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code JQP·July 27, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 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