BEUDAMED
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    Filters Classification: Class Ii ×

    Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, Inc.·July 24, 2019

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Enforcement
    Class II ·Terminated·Mar-Med Co·February 10, 2021

    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·September 10, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

    FDA Enforcement
    Class II ·Ongoing·HUMAN MED AG·March 12, 2025

    Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·January 21, 2015

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 17, 2016

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 20, 2016

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

    Merge RadSuite software. Radiological image processing system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 14, 2016

    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·December 7, 2016

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·May 31, 2017

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 31, 2016

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 25, 2017

    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·May 10, 2017

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 20, 2016

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017