BEUDAMED
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    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Recall
    Terminated ·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017

    NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

    FDA Recall
    Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·December 17, 2007

    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

    FDA Recall
    Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.

    FDA Recall
    Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·February 10, 2010

    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

    FDA Recall
    Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

    Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE

    FDA Recall
    Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code GEN·September 20, 2018

    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.

    FDA Recall
    Terminated ·Philips and Neusoft Medical Systems Co., Ltd. No. 2 Xiu xiu Street Hunnan; Sujiatun Shenyang China·Product code JAK·March 24, 2016

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    FDA Recall
    Terminated ·IntroMedic Co., Ltd. F-Rtek 6 Floor 11-25 Simindaero327beon-Gil; Dongan Anyang Korea (the Republic of)·Product code NEZ·February 15, 2017

    Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model APS-21R - 2.1 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 07004 USA

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·October 1, 2001

    Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-HX-75 - 1.5 m2 surface area and AM-BIO-HX-100 - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

    FDA Recall
    Terminated ·Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of)·Product code ESW·October 18, 2019

    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

    FDA Recall
    Terminated ·CORENTEC CO., LTD Seobuk-gu 12 Yeongsanhong 1-gil Seobuk-gu, Cheonan-si Korea (the Republic of)·Product code LPH·February 27, 2017

    The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005

    The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005

    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    FDA Recall
    Terminated ·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD No. 2 Yong Chang North Rd. Beijing Econ. & Tech. Dev. Zone Beijing China·Product code OXO·September 18, 2013