BEUDAMED
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    SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131258595·H150, RITE 312 WL CNB HHM

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102657·FUKASAKU LIEBERMAN SPATULA, LEFT

    DERF NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022126·DERF NEEDLE HOLDER TUNGSTEN CARBIDE DUST TIP

    MICROPLEX COIL SYSTEM- COSMOS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BENZODIAZEPINE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GENISTRONG

    FDA Adverse Event
    Malfunction ·GENICON·Product code GCJ·October 15, 2017

    REAMER Ø6/10 CANN L435 NO. 511.760

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·March 13, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 29, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 13, 2011

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL QUEBEC, LP·Product code FNL·August 22, 2008

    Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Terminated ·Cordis Corporation·Product code FGE·November 15, 2017

    Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

    FDA Recall
    Terminated ·Cordis Corporation·Product code LIT·December 22, 2014

    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DRE·December 31, 2015

    Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.

    FDA Recall
    Terminated ·Cordis Corporation·Product code LOX·January 31, 2011

    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.

    FDA Recall
    Terminated ·Cordis Corporation·Product code LOX·January 31, 2011

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015