BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    RANGE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131256171·NERA PRO, BTE 13 WL 100 CNB

    Sasmar Vanilla

    FDA UDI
    Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

    MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACON STREP A RAPID TEST DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·August 22, 2008

    Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device, 25T, StanBio (6100-025L), E-Z Well Strep A Test Device, 5T, StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette, McKesson (32-502); Poly stat Strep A Cassette Test, Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test, Cardinal Health (B1077-26). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

    FDA Recall
    Terminated ·Alere San Diego·Product code GTY·September 1, 2011