THOR

Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and all serial numbers .

Radiology Devices

2

No

Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.

Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901, and all serial numbers.

Radiology Devices

2

No

Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.

Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Cardiovascular Devices

3

Yes

International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Valiant Thoracic Stent Graft with Captivia Delivery System, || Talent Thoracic Stent Graft with the Captivia Delivery System.

Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.

Orthopedic Devices

2

Yes

Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.

STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW || REF 26-SETSCREW || NON-STERILE, SINGLE USE, RX ONLY

Lot No. 1212-001, 1212-034

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 || Product Usage: || Short term percutaneous fluid drainage.