BEUDAMED
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    Foley Balloon Catheter for Urology

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HHM

    FDA UDI
    Oticon A/S·05707131354846·G500 SC, MINIRITE 312 2.4G C047 HHM

    DIAPHYSARY TRIAL SHAFT ESOP DIAMETER 13

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489017766·

    NA

    FDA UDI
    Synthes GmbH·10886982142818·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

    Symmetry Hayes

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482057742·Symmetry® Retractor, Hayes Hand, 3.5 mm, 6 1/4 in

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2017760·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...

    KSEA QUADRO SWITCH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962112847·HAYES HAND RETRACTOR, 6 1/4", 3MM

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    OTOLOGY VENT TUBE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETD·August 9, 2017

    ITREL 3

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 17, 2008

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013

    BD MICROLANCE¿ 3 HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 12, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·January 14, 2019

    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

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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