15 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XRpad2 4343 HWC-M Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
Mckesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479259710·Dry Ice Handling Convenience Kit
Neuro Cochlear Implant System
FDA UDI
NEURELEC·03663227001846·PACKING SET, NEURO2 ZTI EXCHANGE BOX C098
Origin 125º Short Neck Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215024178·
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FLOWCARE TLG REAGENT
FDA 510(k)
FDA Class 2
·Hematology
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 21, 2013
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Other
·DEXCOM, INC.·Product code MDS·July 14, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·September 25, 2008
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 1, 2022
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020