59 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
FDA Recall
Terminated
·ARKRAY USA INC.·Product code LJX·March 24, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·September 3, 2010
GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·September 3, 2010
Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
FDA Recall
Terminated
·B Braun Medical, Inc·Product code FRN·August 24, 2010
Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
FDA Recall
Terminated
·Pelton & Crane Company·Product code KLC·February 24, 2010
Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
FDA Recall
Terminated
·Pelton & Crane Company·Product code KLC·February 24, 2010
Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
FDA Recall
Terminated
·Pelton & Crane Company·Product code KLC·February 24, 2010
Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
FDA Recall
Terminated
·Pelton & Crane Company·Product code KLC·February 24, 2010
Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
FDA Recall
Terminated
·Pelton & Crane Company·Product code KLC·February 24, 2010
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·January 26, 2012
Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·June 24, 2010
MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·March 3, 2011
Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·February 24, 2010
Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code MHX·September 23, 2010