40 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CFN·May 27, 2024
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CFN·July 12, 2023
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code JMO·June 26, 2025
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HRS·November 1, 2021
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HRS·November 1, 2021
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Recall
Open, Classified
·Dentsply IH, Inc.·Product code NDP·July 24, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Recall
Open, Classified
·Dentsply IH, Inc.·Product code NDP·July 24, 2025
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·November 17, 2022
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025