61 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
FDA Enforcement
Class II
·Ongoing·Medtronic Neuromodulation·April 14, 2021
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·January 11, 2023
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Enforcement
Class II
·Terminated·LABSTYLE INNOVATIONS·November 6, 2019
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·June 25, 2014
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
wDR 2.2 Mobile Digital Diagnostic X-Ray System
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·July 5, 2023
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 12, 2012
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·September 12, 2018
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 17, 2016
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 8, 2014
DigitalDiagnost C90, Model No. 712034 and 712035
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 5, 2023
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 17, 2016
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 21, 2015