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    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Recall
    Terminated ·GE Healthcare·Product code KPS·March 5, 2015

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Recall
    Terminated ·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015

    GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·October 25, 2005

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·January 12, 2018

    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·November 24, 2008