BEUDAMED
    22 results · 35ms · Sources: EU EUDAMED, US FDA

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    Encore Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257073391·PROTECT PATELLA TRACKING BRACE, RT, 2X

    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857307995·Parallel Rasp Size: 18x45x10 mm

    RTVUE CAM WITH CORNEAL POWER UPGRADE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNIPOD 5 POD

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·June 1, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 3, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Death ·INSULET CORPORATION·Product code LZG·July 19, 2023

    SURGIMEND

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·October 16, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 8, 2013

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·December 13, 2023

    OMNIPOD DASH, PODS 10-PACK

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 9, 2023

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 23, 2024

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 21, 2022

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·July 11, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·April 17, 2023

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024