BEUDAMED
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    DR5000 DEDICATED CHEST X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143411·

    Straumann

    FDA UDI
    Preat Corporation·00842092180075·Titanium Scan Body for Straumann Tissue Level WN

    Gensini™

    FDA UDI
    MEDTRONIC, INC.·00763000199166·WVN CATH 001341 10PK 6F 125CM GENSINI

    Gensini™

    FDA UDI
    MEDTRONIC, INC.·00613994964663·WVN CATH 001341 10PK 6F 125CM GENSINI

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001341·artVeneer life upper anteriors, BIM, C2

    ImmunoFA Toxoplasma IgM Positive Control

    FDA UDI
    GenBio·00613745013411·Positive control for use with ImmunoFA Toxoplas...

    OptiMesh Multiplanar Expandable Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7401001341·Bevel Graft Tube

    AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER FREE STERILE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 23, 2026

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 23, 2026

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 11, 2014

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 18, 2025

    2520274-2013-01419

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 13, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·February 25, 2011

    GE OEC 6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008

    COUPLER AC ZOOM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code FEM·October 14, 2021

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 17, 2021

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

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