16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
FDA 510(k)
FDA Class 2
·General Hospital
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512183·"An absorbent paper points is an endodontic pap...
SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025
SURGIFLATOR-40
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 17, 2008
PERCUTANEOUS TRIAL LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
LINOX SMART S 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 2, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
BD INTIMA-II
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·November 3, 2023
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
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
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026