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    LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

    FDA Recall
    Open, Classified ·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024

    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

    FDA Recall
    Open, Classified ·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024

    Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Recall
    Terminated ·Won Industry Co. 7-12 Bangadari-Gil Siheung-si Korea (the Republic of)·Product code IRP·January 13, 2017

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    FDA Recall
    Open, Classified ·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    FDA Recall
    Open, Classified ·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022

    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Recall
    Terminated ·Won Industry Co. 7-12 Bangadari-Gil Siheung-si Korea (the Republic of)·Product code IRP·January 13, 2017

    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

    FDA Recall
    Terminated ·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of)·Product code NKB·May 26, 2020

    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

    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

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    FDA Recall
    Terminated ·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu-Si Gyeonggi-Do Korea (the Republic of)·Product code OVE·January 30, 2019

    Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

    FDA Recall
    Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    FDA Recall
    Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

    FDA Recall
    Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A

    FDA Recall
    Open, Classified ·Agilent Technologies·Product code KPA·April 2, 2024

    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·July 27, 2012

    DYNEX Agility, Agility Analyzer, Model No. 67000

    FDA Recall
    Open, Classified ·Dynex Technologies, Inc.·Product code LXG·July 5, 2020

    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

    FDA Recall
    Open, Classified ·Dynex Technologies, Inc.·Product code LXG·July 16, 2025

    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

    FDA Recall
    Open, Classified ·Agilent Technologies, Inc.·Product code PPM·May 20, 2022

    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code LLZ·June 26, 2015

    Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·September 2, 2014