BEUDAMED
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    SAPHENOUS VEIN CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514923·CODMAN® Surgical Patties 5/16" (0.79cm) Dia

    CODMAN

    FDA UDI
    Cerenovus, Inc.·20886704036446·CODMAN Surgical Patties 5/16 Inch (0.79cm) Dia.

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00852979003571·Vukich Loading Forceps, Direct Acting

    ACUMED

    FDA UDI
    Acumed LLC·10806378049071·3.0mm Drill, 4.0mm Shank, QR

    Finetest Lite Smart Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SWISSPLANT DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD - 8010379·Product code KWA·May 8, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007

    Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010

    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. 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

    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. 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

    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