11 results · 8ms · Sources: EU EUDAMED, US FDA

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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