BEUDAMED
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    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Enforcement
    Class I ·Terminated·I-Flow Corporation·September 5, 2012

    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

    Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code OYK·November 17, 2011

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    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

    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

    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

    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

    VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·March 1, 2010

    Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·October 6, 2011

    GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·August 5, 2008

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 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

    Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012