BEUDAMED
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    ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139234514·Corin BiPolar-i Ø60/28mm

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010036834·PEDIATRIC PLATE HOLDING CLAMP

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052306·.9mm Twist Drill, 6mm STOP, Hex Shank

    WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

    FDA 510(k)
    FDA Class 2 ·Dental

    EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNK RESECTION BLOCK

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LXH·October 21, 2019

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    CBK

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 18, 2011

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2026

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 3, 2026

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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