BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Catalyft PL Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-PASS

    FDA UDI
    Smith & Nephew, Inc.·03596010534460·ACCU-PASS SUTURE SHUTTLE 45 ...

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185343·AccuFit™ Molar Band UL7 - 42.5

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756814249·RIGID COLLAR

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    HC-BIOS DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACCU-PASS STR SHUTTLE 45 DEG UP

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·June 30, 2020

    ACCU-PASS STR SHUTTLE 45 DEG UP

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·September 4, 2020

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    DC EXTENSION CABLE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 8, 2011

    ELLIPSE DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    ACCU-PASS STR SHUTTLE 45 DEG UP

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LXH·November 19, 2020

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    DIALY-NATE PERITONEAL DIALYSIS SET

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC.·Product code FKO·August 24, 2021

    StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020