12 results
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18ms
·
Sources: EU EUDAMED, US FDA
AUTO CELL DILUENT
FDA 510(k)
FDA Class 1
·Hematology
Ceramill® Zolid
FDA UDI
Amann Girrbach AG·E4947601241·
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471178171·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981152413·Angled Hook, 4.0 x 4.25mm, Right
Straumann ZOLID-SHT
FDA UDI
Amann Girrbach AG·E494760124STM1·
ATRIUM FLIXENE GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
NAIL, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES(USA)·Product code JDS·April 18, 2014
3007566237-2012-02313
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·September 26, 2012
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 8, 2015
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025