Point

Serial Numbers: 1001, 1002, and 1003

Radiology Devices

2

No

Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.

Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

All software versions

Radiology Devices

2

No

Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.

CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361.)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.

Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. || For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.

Lot Number: 7291713, Expiration Date: 2012-10.

Orthopedic Devices

1

No

Worldwide Distribution -- United States, Japan and Belgium.

BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. || Intended for use in arthroscopic procedures.

Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.

Neurological Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.

Mitaka Point Setter, holding system for surgical instruments. || Holding surgical instruments during operating procedures.