31 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
FDA Enforcement
Class II
·Ongoing·Microgenics Corporation·July 6, 2022
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
FDA Enforcement
Class II
·Terminated·Microgenics Corporation·October 12, 2016
QMS Tacrolimus Calibrators, Product code 10015573
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 17, 2024
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·January 1, 2020
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
FDA Enforcement
Class II
·Terminated·Custom Assemblies Inc·August 30, 2017
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
FDA Enforcement
Class II
·Ongoing·Custom Medical Specialties, Inc.·March 1, 2017
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·April 29, 2015
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·September 25, 2013
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
FDA Enforcement
Class II
·Ongoing·Edan Diagnostics·January 28, 2026
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
FDA Enforcement
Class II
·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
FDA Enforcement
Class II
·Terminated·Stradis Medical, LLC dba Stradis Healthcare·December 29, 2021
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·April 29, 2015
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·April 29, 2015
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 6, 2013
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
FDA Enforcement
Class II
·Terminated·Vygon Corporation·March 20, 2013
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012