249 results · 12ms · Sources: EU EUDAMED, US FDA

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BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CGI·August 26, 2020

Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CGI·December 8, 2009

ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;

FDA Recall
Terminated ·Microgenics Corporation·Product code JJY·December 14, 2011

AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

FDA Recall
Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

FDA Recall
Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

Multitom RAX with software version VF10

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021

Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

FDA Recall
Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

FDA Recall
Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

FDA Recall
Terminated ·Microgenics Corporation·Product code JJY·October 20, 2014

D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

FDA Recall
Terminated ·GE Healthcare·Product code CCL·April 24, 2015

Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

Meridian Multiprogrammable Pacemaker, DDDR Model 1276

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Tip Shape, CS-Extended H, REF 6778

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

Discovery II Multiprogrammable Pacemaker, Model 1284

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·June 23, 2003

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

Discovery Multiprogrammable Pacemaker, DDDR Model 1273

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

Pulsar Multiprogrammable Pacemaker, DDDR Model 1272

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004