13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Guardian Needle Electrode
FDA 510(k)
FDA Class 2
·Neurology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742945·Ostrom Antrum Punch (Backbiter), working length...
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
XYLOS VESSEL GUARD
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·July 2, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
UNIVERSAL HIGH TORQUE DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·July 1, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 2, 2013
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
ROCHE COBAS AMPLIPREP INSTRUMENT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS LTD·Product code JJH·September 4, 2008
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016