21 results · 29ms · Sources: EU EUDAMED, 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