BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189720·LEVAMED ACTIVE ANKLE SUP BLACK L III

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776118235·AO Coupling Drill Ø2.0mm, 125/23mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120230·Screwdriver, Extended Tab, Fixed Tap Sleeve, As...

    ADVANTAGE DRIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD INSYTE AUTOGAURD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 16, 2024

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·May 29, 2012

    HT70 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 15, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 10, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Death ·PHYSIO-CONTROL, INC.·Product code MKJ·March 12, 2008

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·January 11, 2019

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 23, 2024

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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