BEUDAMED
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    ROCHE ACETAMINOPHEN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    InnoSpire Mini

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730002064·InnoSpire Mini Battery, 50-pack

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911072614·.017 X .025 POSTED SS RIGHT FORM WIRES 26MM (10)

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306818110·Kelly Retractor 3" X 6" with Simposn Handle

    Vienna Ring CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213052611·Bolt for Needle Fixation Tool, 26mm

    HOSPITAL NASAL MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BYG·December 22, 2011

    CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

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

    MODIFICATION TO MIRAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 20, 2022

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 1, 2012

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 1, 2011

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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