BEUDAMED
    25 results · 34ms · 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 ×

    Electric Wheelchair (XW-LY001)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Intraoral Scan Body EV/4.2

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075038·

    RAGNELL SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083707·RAGNELL SCISSORS FLAT CURVED TIP POWER CUT GOLD

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006644·2.4/3.0mm Screwdriver Shaft, Long, Osteopower

    Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225397·Targeting Guide

    S52D DIGITAL VIDEO LAPAROSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DERMABOND NX ADHESIVE MODEL: DNX6, DNX12

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·September 30, 2019

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 30, 2004

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·July 24, 2020

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 30, 2004

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 20, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    UNK - EX-FIX: ELBOW HINGED

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KTT·April 12, 2021

    UNK - SCREWS: 7.3 MM CANNULATED

    FDA Adverse Event
    Injury ·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code HWC·June 3, 2022

    SINGLE USE GUIDWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·July 14, 2020

    BAB FLEXIBLE FABRIC EXTRA LARGE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·June 29, 2020

    ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014