15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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