BEUDAMED
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    Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 21, 2008

    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 19, 2014

    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 19, 2014

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

    FDA Enforcement
    Class II ·Terminated·Elekta Instrument AB·July 8, 2020

    Light Source, Endoscope, Xenon Arc

    FDA classification
    FDA Class 2 ·Light Source, Endoscope, Xenon Arc

    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.

    FDA Enforcement
    Class II ·Terminated·Advanced Photonic Systems, LLC·September 24, 2014

    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·August 18, 2014

    HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah, NJ 07430 A Subsidiary of Stryker Corp.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 30, 2007

    Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430; A subsidiary of Stryker Corp. Sterile, Made in USA.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 30, 2007

    Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/Bluetooth

    FDA UDI
    VASOMEDICAL, INC.·00817980020290·ARCS ABP Analysis & Reporting Software & Dongle...

    Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECG

    FDA UDI
    VASOMEDICAL, INC.·00817980020221·ARCS Analysis & Reporting Software Dongle Only,...

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·October 11, 2023

    Cascade IOMAX Cortical Module, REF: 190296-200

    FDA Enforcement
    Class II ·Ongoing·Cadwell Industries Inc·May 29, 2024

    Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes

    FDA Recall
    Terminated ·Healthway Home Products, Inc.·Product code FRF·January 9, 2012

    Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·May 29, 2007

    Secur-Fit ARC/HA Collar Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·November 13, 2008

    Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAA·September 21, 2005

    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

    FDA Recall
    Terminated ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·June 10, 2020