10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CellFX System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05714464009541·BERNAFON ALPHA 7 MNR T R SABE/MSIL
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 4, 2008
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 24, 2011
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025