BEUDAMED
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    Pentacam AXL Wave

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704066897·CODMAN SLIM-LINE Aneurysm Clip Straight Blade L...

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750005338·CLIP SET STRAP LOCK 5PC PFT HG

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04718005159871·Comet Lumbar Implant Driver

    FAA Airline - 24 Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446841678·SPECIAL, EMPOWR DUAL MOBILITY LINER TRIAL, SZ 50I

    STIMULAN -CALCIUM SULFATE BONE VOID FILTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS

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

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152444·20F x 1.7cm MiniSPC Low Profile Suprapubic Cath...

    TERRA NOVA® MI Access System

    FDA UDI
    VB Spine LLC·10888857185760·Medium Retractor Distractor, Size 50 mm

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 22, 2012

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 26, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 11, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 27, 2014

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025