28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENSIS, SENSIS LITE
FDA 510(k)
FDA Class 2
·Cardiovascular
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001021318120·OneLIF Interbody, Medium, 13 Degree, 18mm X 12mm
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001121318120·Trial-OneLIF Interbody, Medium, 13 Degree, 18mm...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321318120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311318120·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446153·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446191·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446207·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446146·
DVR® CROSSLOCKMEDIUM PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811720·
DVR® CROSSLOCKPLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811706·
DVR® CROSSLOCKMINI PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811805·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446184·
DVR® CROSSLOCKLONG PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811744·
DVR® CROSSLOCKEXTRA EXTRA LONG PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811881·
DVR® CROSSLOCKEXTRA LONG PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)
FDA UDI
Biomet Orthopedics, LLC·00880304811867·
DVR® CROSSLOCK
FDA UDI
Biomet Orthopedics, LLC·00887868446160·
CONSTRUX MINI PEEK SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 30, 2022