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Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Orthopedic Devices
Regeneration Technologies, Inc.
2
United States
Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Orthopedic Devices
Regeneration Technologies, Inc.
2
United States
Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Orthopedic Devices
Regeneration Technologies, Inc.
2
United States
1.0cc Regenaform RT.
Orthopedic Devices
Regeneration Technologies, Inc.
2
United States
Introducer, Catheter
Cardiovascular Devices
Oscor Inc.
2
United States
Hydrocision
Orthopedic Devices
Hydrocision, Inc.
2
United States
Hydrocision
Orthopedic Devices
Hydrocision, Inc.
2
United States
Electrosurgical Unit
General and Plastic Surgery Devices
Conmed Electrosurgery
2
United States
Electrosurgical Unit
General and Plastic Surgery Devices
Conmed Electrosurgery
2
United States
Kendall Monoject
General Hospital and Personal Use Devices
Kendall a Division of Tyco Healthcare Group LP
2
United States
Micrus
Cardiovascular Devices
Micrus Endovascular Corporation
2
United States
Abbott AxSYM Matrix Cells
Clinical Chemistry and Clinical Toxicology Devices
Abbott Diagnostic International, Ltd.
1
United States
Architect FSH Calibrators
Clinical Chemistry and Clinical Toxicology Devices
Abbott Diagnostic International, Ltd.
2
United States
FSH Calibrators
Clinical Chemistry and Clinical Toxicology Devices
Abbott Diagnostic International, Ltd.
2
United States
AxSYM FSH Master Calibrators
Clinical Chemistry and Clinical Toxicology Devices
Abbott Diagnostic International, Ltd.
2
United States
Home Access Hepatitis C Check
Immunology and Microbiology Devices
Home Access Health Corp (HAHC)
3
United States
Asahi AMR Series Hollow Fiber Dialyzers
Gastroenterology-Urology Devices
Asahi Medical Co., Ltd
2
United States
Asahi AMBIO D Series Hollow Fiber Dialyzers
Gastroenterology-Urology Devices
Asahi Medical Co., Ltd
2
United States
Asahi AMBIO Series Hollow Fiber Dialyzers
Gastroenterology-Urology Devices
Asahi Medical Co., Ltd
2
United States
Asahi Rexeed Series MultipleUse Hollow Fiber Dialyzers
Gastroenterology-Urology Devices
Asahi Medical Co., Ltd
2
United States
Asahi APS Series MultipleUse Hollow Fiber Dialyzers
Gastroenterology-Urology Devices
Asahi Medical Co., Ltd
2
United States
HDL Cholesterol Reagent
Clinical Chemistry and Clinical Toxicology Devices
Stanbio Laboratory, Inc
1
United States
HDL Cholesterol Reagent
Clinical Chemistry and Clinical Toxicology Devices
Stanbio Laboratory, Inc
1
United States
HDL Cholesterol Reagent
Clinical Chemistry and Clinical Toxicology Devices
Stanbio Laboratory, Inc
1
United States
1100 Series Aluminum Retractors
General and Plastic Surgery Devices
Lone Star Medical Products, Inc
1
United States
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