BEUDAMED
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    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code DRC·March 12, 2018

    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.

    FDA Recall
    Terminated ·GYN Disposables Inc·Product code HDC·July 29, 2011

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012

    ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

    FDA Recall
    Terminated ·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)·Product code EXY·April 21, 2022

    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·March 14, 2017

    Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·September 28, 2006

    Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·May 5, 2006

    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code LCM·May 31, 2005

    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·September 28, 2006

    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 19, 2017

    AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 26, 2016

    TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 19, 2017

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code PIO·November 10, 2020

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016