BEUDAMED
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    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.

    FDA Recall
    Open, Classified ·Merz North America, Inc.·Product code LNM·September 30, 2020

    Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LNM·September 23, 2005

    BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

    FDA Recall
    Terminated ·Axonics Modulation Technologies, Inc.·Product code LNM·June 3, 2021

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

    FDA Recall
    Terminated ·Atlas Spine, Inc.·Product code MQP·July 26, 2013

    HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·April 30, 2014

    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

    FDA Recall
    Open, Classified ·mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium·Product code KNN·November 28, 2023

    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

    Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

    FDA Recall
    Open, Classified ·Agiliti Health Ellis·Product code FNM·January 21, 2026

    Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

    FDA Recall
    Terminated ·Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China·Product code FNM·April 15, 2021

    Stryker Arise 1000EX mattress, Part Number 2236000000

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FNM·October 31, 2025

    BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HNM·November 20, 2007

    Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

    FDA Recall
    Open, Classified ·Turncare, Inc·Product code FNM·November 1, 2023

    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

    FDA Recall
    Terminated ·American National Mfg Inc·Product code FNM·July 11, 2016

    Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.

    FDA Recall
    Terminated ·Encompass Therapeutic Support Systems dba BG North America·Product code FNM·March 5, 2010

    Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)

    FDA Recall
    Open, Classified ·Turncare, Inc·Product code FNM·August 10, 2023