BEUDAMED
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    AIR PURIFIER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110560·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.4 PORT

    S2 RECON NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASCEND AQ URETERAL BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code EZN·April 9, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2012

    ENSEAL TRIO 3MM CURVE TIP 35CM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·July 19, 2010

    Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection

    FDA Recall
    Terminated ·Heritage Labs International LLC·Product code LCP·January 9, 2011

    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