BEUDAMED
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    AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602091·Mini-Mono-Brackets Edgew. 'S' .018" 20 Brackets

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600090·Tray Insert, Level II

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600090·Tray Insert, Lumbar Instruments, 1

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600090·Tray Insert, Disc Prep 2

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602000·Tray base, 2"

    ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    DOSE 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·April 16, 2013

    PLUS CERAMIC

    FDA Adverse Event
    Injury ·SMITH & NEPHEW AG·Product code KWY·June 16, 2008

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 15, 2011

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016