16 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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