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Sources: EU EUDAMED, US FDA
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Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
FDA Enforcement
Class II
·Terminated·Omnyx Llc·December 18, 2013
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.
FDA Enforcement
Class II
·Terminated·Arjohuntleigh Magog, Inc.·February 17, 2021
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
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
FDA Enforcement
Class I
·Terminated·Synapse Biomedical Inc·August 31, 2022
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
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
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
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