BEUDAMED
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    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.

    FDA Recall
    Terminated ·Kinamed Inc·Product code KTT·August 18, 2010

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·May 27, 2015

    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code JGS·December 9, 2019

    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code JGS·December 9, 2019

    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 5, 2020

    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 5, 2020

    The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191.

    FDA Recall
    Terminated ·Proctor & Gamble Co·Product code JEQ·February 23, 2005

    The product is a battery operated toothbrush. Spinbrush Pro Ex Soft battery operated toothbrushes UPC 76687800078

    FDA Recall
    Terminated ·Proctor & Gamble Co·Product code JEQ·February 23, 2005

    KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA)

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·September 30, 2008

    Oral-B CrossAction PowerMAX Rechargeable Toothbrush, , Soft 4 Accent Colors: Blue, Pink, Green. Purple NDC 0-69055-83293-6

    FDA Recall
    Terminated ·Gillette Research Institute·Product code JEQ·October 27, 2004

    EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

    FDA Recall
    Terminated ·Varian Medical Systems·Product code JAQ·February 6, 2004

    GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system, for radiation therapy.

    FDA Recall
    Terminated ·Varian Medical Systems·Product code JAQ·May 1, 2006

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019