BEUDAMED
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    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·April 11, 2018

    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 18, 2013

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    FDA Enforcement
    Class II ·Terminated·Remington Medical, Inc.·January 4, 2023

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    FDA Recall
    Terminated ·Remington Medical, Inc.·Product code KNW·December 2, 2022

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    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

    Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·January 19, 2007

    Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 15, 2005

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Recall
    Terminated ·X-NAV Technologies, LLC·Product code PLV·February 23, 2016

    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code MDS·July 15, 2020

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.

    FDA Recall
    Terminated ·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008

    Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065

    FDA Recall
    Terminated ·Freedom Designs Inc·Product code IOR·May 14, 2007