33 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)
FDA Class 2
·Microbiology
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304238862·
HHM
FDA UDI
Oticon A/S·05707131286963·H110V2, RITE 312 WL SIL HHM
JACOBSON-GEMINI MIXTER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896024328·JACOBSON-GEMINI MIXTER FORCEPS RIGHT ANGLED FUL...
Patella Inlay Reamer Sleeve Size 5
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074210·
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 17, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
CENTRAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARTHERX CORKSCREW FT II SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 31, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 16, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 31, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 7, 2011