BEUDAMED
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    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502310·CROSS HAIR TARGET, STAINLESS - ingoing part CRO...

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102007·SS Suture, 3 per sleeve

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319701508·Probe & Packer 6" (15cm), blunt probe & 2 x 25m...

    RESPONSE 2000 HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATHENA REMOTE CONTROLLED RF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    BARD PARKER

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·March 12, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·May 7, 2008

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024