98 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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 Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Enforcement
Class I
·Ongoing·ROi CPS LLC·February 12, 2025
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