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

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    CLINILAB AUTOMATED URINALYSIS SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CO-1000 COLPOSCOPE, MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 21, 2014

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 20, 2007

    CONSERVE(R) PLUS HA CUP

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·September 26, 2012

    Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-024-35-2509, l) 02-024-35-2510, m) 02-024-35-2511, n) 02-024-35-2512, o) 02-024-35-3010, p) 02-024-35-3011, q) 02-024-35-3012, r) 02-024-35-3013, s) 02-024-35-3513, t) 02-024-35-3515, u) 02-024-35-4012, v) 02-024-35-4013, w) 02-024-35-4510, x) 02-024-35-4515, y) 02-024-35-5011, z) 02-024-35-5012, aa) 02-024-44-1511, bb) 02-024-44-2009, cc) 02-024-44-2011, dd) 02-024-44-2015, ee) 02-024-44-2510, ff) 02-024-44-2515, gg) 02-024-44-3009, hh) 02-024-44-3011, ii) 02-024-44-3013, jj) 02-024-44-3015, kk) 02-024-44-3509, ll) 02-024-44-4009, mm) 02-024-44-4509, nn) 02-024-44-4511, oo) 02-024-44-4512, pp) 02-024-44-4513, qq) 02-024-44-5013

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·December 27, 2023