10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIO CAD/CAM Abutment
FDA 510(k)
FDA Class 2
·Dental
CRANIALMAP
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327327151·CRANIALMAP PLANNING SALES DEMO
SignaLoc Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215117023·
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WATCH-PAT 200I (WP200I)
FDA 510(k)
FDA Class 2
·Anesthesiology
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 20, 2013
OPTIFLEX-S CPM PKG
FDA Adverse Event
Malfunction
·ORMED·Product code BXB·September 29, 2008
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021