631 results
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8ms
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Sources: EU EUDAMED, US FDA
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
FDA Enforcement
Class II
·Terminated·Thermo Fisher Scientific (Monterrey)·June 3, 2020
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
FDA Enforcement
Class II
·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
FDA Enforcement
Class II
·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
FDA Enforcement
Class II
·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·April 2, 2014
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories·September 26, 2012
Extra corporeal circuit with bio-active surface.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·July 15, 2020
Bio-CORE Cannula (Needle) Set
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
Bio-PLASTY Cannula (Needle)
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-MAC Cannula (Needle) Set
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 2, 2016