BEUDAMED
    38 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ReTurn 7500/7500 Aid, transfer

    FDA Enforcement
    Class II ·Terminated·Handicare USA, Inc.·November 2, 2016

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Enforcement
    Class II ·Ongoing·PATH·December 24, 2025

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    FDA Enforcement
    Class II ·Terminated·Opgen Inc·May 22, 2019

    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

    FDA Enforcement
    Class II ·Ongoing·Owen Mumford USA, Inc.·July 21, 2021

    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·April 8, 2015

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·July 22, 2015

    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·January 24, 2018

    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·January 24, 2018

    Autoject EI, REF AJ1310

    FDA Enforcement
    Class II ·Ongoing·Owen Mumford USA, Inc.·November 13, 2019

    Petfine Auto Injector, REF 3310VET

    FDA Enforcement
    Class II ·Ongoing·Owen Mumford USA, Inc.·November 13, 2019

    Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

    FDA Enforcement
    Class II ·Ongoing·Owens & Minor Distribution, Inc.·December 7, 2022

    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·February 10, 2016

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·February 10, 2016

    Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016

    MediChoice Dual-Release Folding Walker with 5" wheel

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·November 26, 2014