BEUDAMED
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    THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONFIDA BRECKER CURVE GUIDEWIRE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602211·Mini-Mono-Brackets Ricketts 'S' .018" 200 Brackets

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306811166·Potts-Smith Forceps, 2.0mm Tip, 21cm

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

    SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DESARA BLUE TV

    FDA Adverse Event
    Injury ·CALDERA MEDICAL INC.·Product code OTN·December 5, 2019

    INFUSE BONE GRAFT DEVICE (RHBMP-2)

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code NEK·April 10, 2013

    JOURNEY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HSA·June 13, 2008

    UNKNOWN MESH PRODUCT (EWHU)

    FDA Adverse Event
    Injury ·ETHICON·Product code FTL·April 15, 2011

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 17, 2016

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022