46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRODIGY DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WIRE END CUTTER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051522·WIRE SIDE CUTTER TUNGSTEN CARBIDE BLADES
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551038832·RULER, FOR 2.1MM DRILL DRIVER
Orthopaedic Surgical Instruments
FDA UDI
CITIEFFE SRL·08056711921310·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking
ACTIS ADJUSTABLE CONSTRICTION LOOP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XVI R4.5
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 17, 2023
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 16, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·September 19, 2014
ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER
FDA Adverse Event
Malfunction
·ETHICON·Product code GDF·May 25, 2011
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2018
UNKNOWN OXFORD TIBIAL COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·August 20, 2025
UNKNOWN OXFORD TIBIAL COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·August 21, 2025