BEUDAMED
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    SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383557139·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383534239·Gutta Percha Points is used to root canal filin...

    APEX MEDICAL LCD TENS-VII

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODEL LTV 1100 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 27, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 25, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 26, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 29, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2013

    ITREL 3

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 23, 2011

    INTERSTIM

    FDA Adverse Event
    Injury ·MPROC, JUNCOS·Product code EZW·August 8, 2008

    THERAPY COOL PATH ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, INC.·Product code LPB·October 31, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021