BEUDAMED
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    QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328587·TEMPLATE 3003959 ZEVO 59MM 3 LVL

    POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CRITERION 60 OR PM 60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JUVEDERM ULTRA PLUS XC TSK US

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·March 12, 2013

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011

    SPINAL STIMULATOR

    FDA Adverse Event
    Injury ·Product code GZB·February 25, 2008

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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