12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BEST PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Coulmed
FDA UDI
Coulmed Products Group LLC·10810087350281·Standard Sterile Surgical Gown, XX-Large, AAMI 3
BE PLUS / AURA-LTM64 AMPLIFIER
FDA 510(k)
FDA Class 2
·Neurology
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDO·November 13, 2014
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·February 9, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 10, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014