15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUICKBRIDGE TM CYLINDER AND CAP
FDA 510(k)
FDA Class 2
·Dental
ConMed
FDA UDI
Provision·B504OM50715510·
NON-BR2000 LARGE BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919095361·KM71-551
NA
FDA UDI
STERILMED, INC.·10888551020862·SAW BLADE OSCILLATING LARGE BONE
NA
FDA UDI
STERILMED, INC.·10888551007634·SAW BLADE OSCILLATING LARGE BONE
CONMED
FDA UDI
Conmed Corporation·10845854001837·OSCILLATOR BLADE, 32.5 X 63 X 0.6 MM (.024")
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
FDA 510(k)
FDA Class 2
·Orthopedic
SURE CHECK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 22, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·April 28, 2011
PAIN BUSTER
FDA Adverse Event
Injury
·*·Product code MEB·July 9, 2008
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022