BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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

    SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASSERACHROM HPIA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 27, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 18, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·March 21, 2008

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024