21 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL™ Sensi-Disc™ Neomycin - 5 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313121·BD BBL™ Sensi-Disc™ Neomycin 5 µg
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021567·INTRG WHISP MBT LAT +10T +8A 022 UL
TraxIt
FDA UDI
MEDICAL INDICATORS INC·00016944701514·TraxIt C DTC Wearable Children's Underarm Sing...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946020316·Defibrillator ,MAIN ASSY, 12LD, SPO2, SPOC, C02...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946017101·Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, NIB...
RTA MODEL D RETINAL THICKNESS ANALYZER
FDA 510(k)
FDA Class 2
·Ophthalmic
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172450·CR Tibial Insert Trial with Posterior Pin Relie...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101443·R CR E-MAXTM Vitamin E Congruent Tibial Insert ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124459·R CR Tibial Insert Trial Sz B 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165629·R CR Tibial Insert Trial with Anterior Slot, Sz...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145119·R CR UHMWPE Congruent Tibial Insert Sz B 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102211·R CR MAXTM HXL Congruent Tibial Insert Sz B 12mm
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 6, 2021
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022