16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112489·BARRON VACUUM TREPHINE 7.25MM
Looper (Model: ZX-579S)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112458·BARRON VACUUM TREPHINE 6.0MM
VICEROY Spinal System
FDA UDI
EOS BIOTEK,INC.·88000163012054·
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800039826280·Rod Pre-Bent 6.0 x 55mm
NovoFine Plus 32G Tip x 4 mm
FDA 510(k)
FDA Class 2
·General Hospital
White ENDOSEAL MTA
FDA 510(k)
FDA Class 2
·Dental
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·June 12, 2023
FLEXIBLE TIP WITH SLIMLINE RETENTION
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FCE·May 16, 2008
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 15, 2022
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 21, 2014
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH LTD. / HUNTINGTON·Product code HQL·August 5, 2011
FITMORE HIP STEM
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·June 26, 2013
MAGNETOM Vida Fit. Model Number: 11410481.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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