15 results · 22ms · Sources: EU EUDAMED, US FDA

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Fundus Camera

FDA 510(k)
FDA Class 2 ·Ophthalmic

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112625·BARRON CORNEAL PUNCH 7.75MM

SprintRay Standard Denture Base - Dark Pink

FDA UDI
Sprintray, Inc.·00850039704413·SprintRay Standard Denture Base is a light-cura...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM

THERMIQUE

FDA 510(k)
FDA Class 2 ·Dental

POWDER FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

I-STAT 6+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·December 8, 2020

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 16, 2008

CAPSUREFIX NOVUS MRI

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·July 13, 2022

SMALLBORE 6 INCH EXT VLV

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 16, 2021

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021