| Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. |
Westmed Inc |
Event 63276 |
January 18, 2011 |
| Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010. |
Nemschoff Chairs, Inc. |
Event 69092 |
January 18, 2011 |
| Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. |
Abiomed, Inc. |
Event 98868 |
January 17, 2011 |
| SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter |
SteriGear, LLC |
Event 68456 |
January 11, 2011 |
| Video Bronchoscope |
Pentax of America Inc |
Event 77310 |
January 11, 2011 |
| Video Naso pharyngo Laryngoscopes |
Pentax of America Inc |
Event 77310 |
January 11, 2011 |
| Video Cytoscopes |
Pentax of America Inc |
Event 77310 |
January 11, 2011 |
| I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood. |
Abbott Point Of Care Inc. |
Event 62371 |
January 01, 2011 |
| ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. |
Kimberly-Clark Corporation |
Event 62577 |
December 31, 2010 |
| M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors |
Philips Electronics North America Corporation |
Event 77437 |
December 17, 2010 |
| TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. |
Alphatec Spine, Inc. |
Event 63599 |
December 09, 2010 |
| Country Fresh Ovens Cheese Coffee Cake, Net Wt 5 oz (142g). Dist. by Country Fresh Ovens, St. Paul Park, MN 55071 |
Super Mom's |
Event 57449 |
December 08, 2010 |
| BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies |
Siemens Healthcare Diagnostics, Inc. |
Event 61768 |
December 01, 2010 |
| Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. |
Pride Mobility Products Corp |
Event 57350 |
November 26, 2010 |
| The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit |
Medtest Holdings, Inc. |
Event 77453 |
November 22, 2010 |
| Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00 |
Physicians Total Care, Inc |
Event 61233 |
November 10, 2010 |
| Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 |
Physicians Total Care, Inc |
Event 61233 |
November 10, 2010 |
| Baugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part ***Fresh*** Preservatives added-keep under refrigeration***. Jugs are labeled in part ***FDA Required Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems***. |
Baugher Enterprises, Incorporated |
Event 57212 |
November 04, 2010 |
| Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. |
Canon Inc. |
Event 62828 |
November 01, 2010 |
