BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    APPLANATION TONOMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...

    TRIDENT HEMISPHERICAL ACETABULAR SHELLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code LHI·March 27, 2013

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 14, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 1, 2008

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29). 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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018