31 results
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19ms
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Sources: EU EUDAMED, US FDA
OXYMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 28, 2018
CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
FDA 510(k)
FDA Class 1
·Dental
AFFIITY CP CENTRIFUGAL BLOOD PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 8, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·October 22, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 7, 2007
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2016
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
FDA Recall
Terminated
·International Technidyne Corp.·Product code GJS·September 28, 2012
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
FDA Recall
Terminated
·International Technidyne Corporation·Product code GGN·April 15, 2010
Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
FDA Recall
Terminated
·Capintec Inc·Product code KPT·July 8, 2011
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 20, 2007
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Recall
Terminated
·Capintec Inc·Product code IZD·March 3, 2020
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 20, 2007
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
FDA Recall
Open, Classified
·Mirion Technologies (Capintec), Inc.·Product code IZD·April 22, 2024
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
FDA Recall
Open, Classified
·Mirion Technologies (Capintec), Inc.·Product code IZD·April 22, 2024
Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
FDA Recall
Open, Classified
·Mirion Technologies (Capintec), Inc.·Product code IZD·April 22, 2024
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·March 5, 2012