35 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
FDA Enforcement
Class II
·Terminated·Alfa Wassermann, Inc.·May 7, 2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
FDA Enforcement
Class II
·Terminated·Alfa Wassermann, Inc.·May 7, 2014
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
FDA Enforcement
Class II
·Terminated·Alfa Wassermann, Inc.·February 6, 2013
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 2, 2016
Focalyx Fusion
FDA Enforcement
Class II
·Ongoing·Focalyx Technologies, LLC.·February 11, 2026
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.
FDA Enforcement
Class II
·Terminated·LED Technologies, LLC·May 4, 2016
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
FDA Enforcement
Class II
·Terminated·Unistrip Technologies LLC·December 31, 2014
Xoran MiniCAT X-ray imaging device
FDA Enforcement
Class II
·Terminated·Xoran Technologies, LLC·March 11, 2015
InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
FDA Enforcement
Class II
·Terminated·Rymed Technologies, LLC·January 27, 2016