BEUDAMED
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    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Recall
    Completed ·Exactech, Inc.·Product code PHX·May 11, 2021

    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·August 15, 2012

    DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

    FDA Recall
    Terminated ·Amd-Ritmed, Inc.·Product code NAC·June 8, 2016

    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code LKM·March 31, 2013

    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.

    FDA Recall
    Terminated ·Amd-Ritmed, Inc.·Product code FQM·March 30, 2016

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Recall
    Terminated ·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017

    Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile)

    FDA Recall
    Terminated ·Product code HBT·October 24, 2003

    Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge

    FDA Recall
    Terminated ·Product code HBT·October 24, 2003

    Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

    Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GJT·May 11, 2015

    Injection Needle, LUER-lock,0.8mm, REF: 26175PD

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code HET·October 24, 2023

    (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code HET·February 23, 2022

    Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code HET·September 28, 2009

    Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

    FDA Recall
    Terminated ·Market-Tiers Inc·Product code HET·July 16, 2014

    Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 6, 2023

    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 20, 2023

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJT·January 28, 2013