BEUDAMED
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    A1417MCW/A1717MCW/F1417MCW

    FDA 510(k)
    FDA Class 2 ·Radiology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551078020·Needle, bay., straight, length 18 cm

    GOMCO

    FDA UDI
    Allied Medical, LLC·00026072001899·UTHERINE ASPIRATOR STAND

    VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COOPERSURGICAL OOCYTE RECOVERY NEEDLES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BIOMET CC I-BEAM TRAY 75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 10, 2017

    BMET ARCOM AP PAT 3PST 34MM MD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 10, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FPO·October 30, 2014

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 5, 2013

    VANGUARD PS OPEN INTL FEM RT 70

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 10, 2017

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025