12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PICIS WEIGHT BASED DOSE CONVERTER
FDA 510(k)
FDA Class 2
·Anesthesiology
SafeGuide® Single
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023273·Disposable Over the Guidewire Esophageal Dilato...
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·April 14, 2021
ADC DENTAL
FDA 510(k)
FDA Class 2
·Dental
HEADWAY 17 ADVANCED MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
AMISTEM H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2025
IDENTITY ADX SR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·May 21, 2013
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 6, 2011
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022