8 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elecsys BRAHMS PCT
FDA 510(k)
FDA Class 2
·Microbiology
SURELIFT PROLAPSE SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
S-LIF INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 4, 2024
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
FDA Adverse Event
Death
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·October 20, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·July 20, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013