BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    GYRUS ACMI BICOAG HEMOSTASIS PROBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704541690·PVC NASOPHARYNGEAL AIRWAY STERILE

    Class A 21 CHG&E - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233192·Class A 21 CHG&E - 18 Metal

    I-SEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUVASIVE MASH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM H CEMENTLESS STEM SIZE 3 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·April 25, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    NIM RESPONSE® STIMULATOR PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·September 26, 2014

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·June 8, 2011

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    Allura Xper FD20/15; System Code: 722058;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026