123 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·July 31, 2013
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
Welch Allyn AED 10 Automated External Defibrillator
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·December 15, 2008
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·December 17, 2013
GE Datex-Ohmeda Advance Anesthesia Gas-Machine.
FDA Recall
Terminated
·GE Healthcare·Product code BSZ·February 5, 2009
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012
Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
FDA Recall
Terminated
·Accutron Inc·Product code BSZ·April 29, 2012