BEUDAMED
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    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code NEW·January 10, 2018

    The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·February 28, 2011

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·April 18, 2018

    Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.

    FDA Recall
    Terminated ·Cook, Inc.·Product code DQY·February 28, 2007

    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    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

    TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device.

    FDA Recall
    Terminated ·Migada Inc. P.O Box 888 Kiryat Shmona Israel·Product code LHI·December 18, 2008

    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MAX·February 18, 2016

    Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·January 19, 2010

    Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006

    Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DTB·September 1, 2009

    Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DTB·February 25, 2010

    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ETB·July 14, 2020

    Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DTB·January 29, 2008

    Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DTB·September 1, 2009

    Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DTB·September 15, 2015

    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ETB·July 14, 2020

    Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006

    enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DTB·May 13, 2010