BEUDAMED
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    MENISCAL SAW

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ACUMED

    FDA UDI
    Acumed LLC·10806378044342·Kickstand Post 5°-30°

    INTRA-AORTIC BALOON CATHETER

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 19, 1998

    PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE

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

    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·May 8, 2014

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 4, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023