BEUDAMED
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    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    FDA Recall
    Terminated ·Neocis, Inc.·Product code PLV·October 30, 2020

    PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS

    FDA Recall
    Terminated ·PerkinElmer, Inc·Product code JQW·October 13, 2016

    Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.

    FDA Recall
    Terminated ·Neocis Inc.·Product code PLV·October 4, 2019

    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows

    FDA Recall
    Terminated ·PerkinElmer, Inc·Product code JQW·June 24, 2016

    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Recall
    Open, Classified ·Neilmed Pharmaceuticals Inc·Product code KCJ·December 28, 2024

    TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code MQV·September 29, 2006

    TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code MQV·September 29, 2006

    Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Recall
    Open, Classified ·GS Biomark LLC·Product code QJR·August 8, 2022

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code CGS·October 19, 2011

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGS·July 18, 2018

    ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·May 3, 2019

    NAD Profile Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CGS·November 3, 2025

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGS·July 18, 2018

    HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

    FDA Recall
    Terminated ·Catheter Research, Inc·Product code HGS·April 7, 2015

    Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017

    Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·May 3, 2019

    CK MB Calibrator, Catalogue Number CK2393

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGS·March 25, 2022

    Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CGS·October 12, 2007

    InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FGS·September 29, 2010