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Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
BD, Salmonella Somatic Polyvalent Antiserum (A,B,D)
Immunology and Microbiology Devices
BD Diagnostic Systems
2
United States
BD, Salmonella O Group D Antigen (9-12) (Typhoid O)
Immunology and Microbiology Devices
BD Diagnostic Systems
2
United States
BD, Brucella melitensis Antigen
Immunology and Microbiology Devices
BD Diagnostic Systems
2
United States
Bosworth Superbite Bite Registration Paste Kit
Dental Devices
Harry J Bosworth Company
2
United States
Bosworth Tray Aways 3
Dental Devices
Harry J Bosworth Company
1
United States
Bosworth TruRepair
Harry J Bosworth Company
United States
OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228
Clinical Chemistry and Clinical Toxicology Devices
International Chemical Inc.
2
United States
OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by ICC, Amherst, NY 14228.
Clinical Chemistry and Clinical Toxicology Devices
International Chemical Inc.
2
United States
Newport HT50 All Purpose Ventilator
Anesthesiology Devices
Newport Medical Instruments Inc
2
United States
Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company Toano, Virginia 23168***Sterile~Disposable~Single Use Only***
General and Plastic Surgery Devices
Avid Medical Inc
2
United States
Analogic SyneRad Multi Digital Radiology System, Model AN6150
Radiology Devices
Analogic Corporation
2
United States
Analogic
Obstetrical and Gynecological Devices
Analogic Corporation
2
United States
Analogic
Obstetrical and Gynecological Devices
Analogic Corporation
2
United States
Stackhouse Lens/Hood, Mark III Universal
General Hospital and Personal Use Devices
VIASYS Med Systems
2
United States
Stackhouse FreedomAire Lens/Hood
General Hospital and Personal Use Devices
VIASYS Med Systems
2
United States
DStat Radial Hemostat Band
General and Plastic Surgery Devices
Vascular Solutions, Inc.
Unclassified
United States
DStat Radial Hemostat Band
General and Plastic Surgery Devices
Vascular Solutions, Inc.
Unclassified
United States
DStat Dry Hemostatic adhesive bandage
General and Plastic Surgery Devices
Vascular Solutions, Inc.
Unclassified
United States
Rita
General and Plastic Surgery Devices
Rita Medical Systems
2
United States
Torque Limiting Handle
Orthopedic Devices
Theken Spine LLC
1
United States
HoverMatt Patient Transfer Solution/Air Transfer Mattress
General Hospital and Personal Use Devices
D.T. Davis Enterprises Ltd.
2
United States
InVision Technologies
Invision Technologies Inc
United States
Omron 3Way Instant Thermometer
General Hospital and Personal Use Devices
Omron Healthcare, Inc.
2
United States
Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set
Hematology and Pathology Devices
Abbott Molecular
Unclassified
United States
Product names: || a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color || b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color || c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless || d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color || e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color || f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless || g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color || All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. || The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. || This product was cleared as a prescription device; however, it is not labeled as such.
Dental Devices
Rite-Dent Manufacturing Corp.
1
United States
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