BEUDAMED
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    MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143541·

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00763000199258·WVN CATHETER 001354 10PK 6F 100CM NIH

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00613994964434·WVN CATHETER 001354 10PK 6F 100CM NIH

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001354·artVeneer life lower anteriors, UBL, C2

    neoBLUE

    FDA UDI
    NATUS MEDICAL INCORPORATED·00382830053198·The neoBLUE cozy™ Phototherapy System is a mobi...

    C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN ORTHOSIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC/HUNTINGTON·Product code HQL·June 2, 2006

    33M HEMORRHOID STAPLER 4.8MM STAPLES

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·March 6, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 25, 2011

    SCD EXPRESS SLEEVE K/L MEDIUM

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/ KENDALL·Product code JOW·February 19, 2008

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC. / HUNTINGTON·Product code KYB·June 30, 2006

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC. / HUNTINGTON·Product code KYB·June 30, 2006

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024