BEUDAMED
    94 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·February 21, 2018

    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

    FDA Enforcement
    Class II ·Completed·Medtronic Inc.·January 10, 2024

    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 5, 2023

    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·February 19, 2020

    Instructions For Use document of the GPS Trackers.

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

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    FDA Enforcement
    Class II ·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016

    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    FDA Enforcement
    Class II ·Terminated·Circadiance LLC·June 14, 2017

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·September 25, 2024

    Regard Kit containing the Microtek decanter

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·August 28, 2024

    Regard Dressing Change Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·May 19, 2021

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·March 9, 2022

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·June 15, 2022

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 6, 2022

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·February 5, 2020