BEUDAMED
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    MARK III ULTRASONIC SCANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257010068·M.3 SOFT OA BRACE, VARUS, LEFT, 2X

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515012·CODMAN® Surgical Patties 1/2" x 2" (1.27cm x 5....

    CODMAN

    FDA UDI
    Cerenovus, Inc.·20886704036538·CODMAN Surgical Patties 1/2 Inch x 2 Inches (1....

    ACUMED

    FDA UDI
    Acumed LLC·10806378049149·Large T Handle Locking Pin Driver

    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURG PAT XRAY 1/2X2 -200

    FDA Adverse Event
    Malfunction ·RAYNHAM·Product code HBA·January 20, 2022

    BD SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 31, 2019

    SURG PAT XRAY 1/2X2 -200

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES MANSFIELD·Product code HBA·January 17, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    UNKNOWN RIGHT REJUVENATE/ABG II HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012

    ACCU-CHEK® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2010

    SURGICAL PATTIE, 1/2 X 1/2

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code HBN·November 11, 2015

    CODMAN SURGICAL PATTIES

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code HBA·November 9, 2015

    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012