48 results · 34ms · Sources: EU EUDAMED, US FDA

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DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

FDA Recall
Open, Classified ·Carestream Health, Inc.·Product code KPR·January 30, 2023

ProxiDiagnost N90 is multi-functional general R/F systems.

FDA Recall
Open, Classified ·Philips Healthcare·Product code OWB·September 22, 2021

CombiDiagnost R90 is multi-functional general R/F systems.

FDA Recall
Open, Classified ·Philips Healthcare·Product code JAA·September 22, 2021

FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·February 13, 2023

FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023

FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

FDA Recall
Open, Classified ·Philips North America Llc·Product code OWB·October 21, 2022

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CBK·January 25, 2023

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CBK·January 25, 2023

Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CBK·January 25, 2023

Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CBK·January 25, 2023

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·October 21, 2021

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·October 21, 2021

AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517760

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ESW·August 1, 2024

AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517720

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ESW·August 1, 2024

AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517740

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ESW·August 1, 2024

AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517820

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ESW·August 1, 2024

AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517800

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ESW·August 1, 2024