BEUDAMED
    32 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    PROPEP DELIVERY DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551148333·SEEG ANCHOR BOLT CAP FITS ANCHOR BOLT 2103-15-X...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515062047·Spencer Stitch Sci, 3 1/2"

    SAV

    FDA UDI
    Diversified Products, Inc.·00037741210344·

    PIERMATTEI PIN DRIVER/BENDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896052147·PIERMATTEI PIN DRIVER/BENDER

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894122426·

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894114315·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

    RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TAPERLOC MICROP FMRL 5.0MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 30, 2018

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 24, 2025

    SNORERX

    FDA Adverse Event
    Injury ·APNEA SCIENCES·Product code LRK·May 22, 2017

    ROTALINK? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·May 9, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 25, 2011

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 26, 2022