BEUDAMED
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    MECTALIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657022705·Laparoscopic Fan Retractor, 5mm Deflectable

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131671·TiBase HIO4.0/6.0 3.0G E

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055369·1.6mm Orbital Floor Plate, Pick, .2mm Thick

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657013376·Fan Retractor, 5mm, Straight Deflect

    POLARIS WR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SINGLE SITE FLEXIBLE BLADELESS OBTURATOR

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

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 10, 2024

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 29, 2024

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 4, 2023

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·May 9, 2005

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    CALIBRATED DRILL BIT Ø3.1MM X 285MM, AO

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code LXH·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015