BEUDAMED
    12 results · 6ms · Sources: EU EUDAMED, US FDA

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

    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

    Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016

    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·January 20, 2016

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 19, 2019

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

    SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 21, 2020

    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 14, 2020