BEUDAMED
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    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·August 8, 2005

    VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGS·December 20, 2016

    Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD

    FDA Recall
    Terminated ·Puritan Bennett Corporation·Product code MNT·August 31, 2006

    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGS·October 17, 2013

    VITROS Sodium Slides, Catalog # 837 9034

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGS·May 5, 2018

    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code JIX·December 16, 2019

    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGS·January 22, 2019

    NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code GAA·January 4, 2021

    NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code GAA·January 4, 2021

    NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code GAA·January 4, 2021

    NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code GAA·January 4, 2021

    NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code GAA·January 4, 2021

    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FMI·July 10, 2017

    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·October 17, 2013

    n/a

    FDA Recall
    Terminated ·Windstone Medical, Inc.·March 25, 2003

    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).

    FDA Recall
    Terminated ·Diametrics Medical, Inc.·Product code JJE·July 14, 2003

    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·March 11, 2011

    NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FCG·January 4, 2021

    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·June 22, 2016