BEUDAMED
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    Thoraguard Chest Tube Kit, 20 Fr

    FDA Recall
    Terminated ·Centese Inc.·Product code GBX·August 31, 2021

    Thoraguard Chest Tube Kit, 20 Fr

    FDA Enforcement
    Class II ·Terminated·Centese Inc.·October 20, 2021

    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

    FDA Enforcement
    Class II ·Terminated·Vascular Solutions, Inc.·June 27, 2018

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·February 10, 2016

    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

    FDA Enforcement
    Class II ·Terminated·Beevers Manufacturing & Supply, Inc.·August 20, 2014

    Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·April 19, 2017

    Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034

    FDA Recall
    Terminated ·Aesculap Inc·Product code HCI·November 1, 2007

    Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034

    FDA Recall
    Terminated ·Aesculap Inc·Product code HCI·November 1, 2007

    American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·June 18, 2007