33 results
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12ms
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Sources: EU EUDAMED, US FDA
VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code GKA·April 14, 2010
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
FDA Recall
Terminated
·MAQUET Inc.·Product code BSZ·July 10, 2007
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
FDA Recall
Terminated
·Maquet Inc·Product code CBK·January 3, 2005
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LBS·February 2, 2012
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LBS·May 7, 2015
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LBS·May 7, 2015
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LBS·March 17, 2016
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LBS·June 12, 2013
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LBS·June 11, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
FDA Recall
Terminated
·Concentric Medical Inc·Product code GBS·February 27, 2009
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9020, Size (Fr) 20, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9124, Size (Fr) 24, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008