BEUDAMED
    56 results · 15ms · Sources: EU EUDAMED, US FDA

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

    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.

    FDA Enforcement
    Class III ·Terminated·Pointe Scientific, Inc.·September 23, 2015

    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

    FDA Enforcement
    Class III ·Terminated·Hardy Diagnostics·November 18, 2020

    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·January 22, 2020

    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·January 22, 2020

    The UNI-CP System; Model Number: 330230SND.

    FDA Enforcement
    Class III ·Terminated·Integra LifeSciences Corp.·March 15, 2017

    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

    FDA Enforcement
    Class III ·Ongoing·Microbiologics Inc·September 20, 2023

    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·August 3, 2016

    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

    FDA Enforcement
    Class III ·Terminated·Zimmer Surgical Inc·May 20, 2015

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    FDA Enforcement
    Class III ·Terminated·National Biological Corp·July 31, 2013

    Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    FDA Enforcement
    Class III ·Terminated·National Biological Corp·July 31, 2013

    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

    FDA Enforcement
    Class III ·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018

    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Enforcement
    Class III ·Terminated·Viscot Medical LLC·April 10, 2013

    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·July 22, 2015

    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Enforcement
    Class III ·Terminated·Bion Enterprises Ltd·June 12, 2013

    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Enforcement
    Class III ·Terminated·Bion Enterprises Ltd·June 12, 2013

    Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Enforcement
    Class III ·Terminated·Bion Enterprises Ltd·June 12, 2013

    Alere iScreen Dx Urine Drug Screen Card

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·May 9, 2018

    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

    FDA Enforcement
    Class III ·Terminated·Covidien LLC·May 22, 2013