11 results
·
8ms
·
Sources: EU EUDAMED, US FDA
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
ROSA One 3.1 Brain Application
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024