21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM
ELECSYS CA 15-3 CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
VAXCEL PERIPHERALLY INSERTED CENTRAL CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code LJS·October 13, 2008
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 18, 2013
NASOPORE
FDA Adverse Event
Injury
·POLYGANICS BV·Product code LYA·August 5, 2011
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 4, 2022
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·April 28, 2023
MEDTRONIC TRANSCATHETER DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 27, 2024
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·May 5, 2023
UNKNOWN TA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·May 5, 2023
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 23, 2024
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·January 11, 2024
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·January 27, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025