BEUDAMED
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    Filters FDA Enforcement × Classification: Class I × Clear all

    10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

    FDA Enforcement
    Class I ·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023

    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

    FDA Enforcement
    Class I ·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023

    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    FDA Enforcement
    Class I ·Terminated·Nephros Inc·December 25, 2013

    ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers

    FDA Enforcement
    Class I ·Terminated·Flexicare Medical Ltd.·December 2, 2020

    Imager II 5F Angiographic Catheters, 5 units per package.

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·April 1, 2020

    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

    FDA Enforcement
    Class I ·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023

    CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·July 24, 2019

    CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·July 24, 2019

    MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·October 9, 2013

    MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·October 9, 2013

    MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·October 9, 2013

    MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·October 9, 2013

    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).

    FDA Enforcement
    Class I ·Ongoing·Nipro Renal Soultions USA, Corporation·May 21, 2025

    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

    FDA Enforcement
    Class I ·Ongoing·NOXBOX LTD·October 15, 2025

    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    FDA Enforcement
    Class I ·Terminated·Nephros Inc·December 25, 2013

    Avanos Cortrak 2 Enteral Access System (EAS)

    FDA Enforcement
    Class I ·Terminated·Avanos Medical, Inc.·May 25, 2022

    Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

    FDA Enforcement
    Class I ·Terminated·Carefusion 2200 Inc·July 11, 2012

    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.

    FDA Enforcement
    Class I ·Terminated·BASE 10 GENETICS INC·February 23, 2022

    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.

    FDA Enforcement
    Class I ·Terminated·Verathon, Inc.·July 15, 2020