Medical Devices

  1. Boston Scientific, Implanted Device: Altura (PDF)

  2. NAVSEA ventilator testing (PDF)

  3. CareFusion End of Sales MedSystem III Infusion Pump (PDF)

  4. FDA and 510k Clearance Explanation (PDF)

  5. 091109 FDA letter to Ocean Hyperbarics for off-label use (PDF)

  6. Radiometer Medical ApS letter concerning latex content in products (Word doc, 60KB)

  7. Medtonic ICD/Pacemaker position statement for HBO (PDF, 20KB)

  8. Medtronic Synchromed® Isomed® implantable infusion systems (PDF)

  9. NEDU Multiplace IV testing (PDF)

  10. St. Jude Medical Cardiac Pacemaker Models and HBO Treatment/SCUBA Diving (PDF)

  11. Guidant JCD/Pacing Systems, Hyperbaric Chambers and SCUBA Diving (PDF)

  12. Exposing Boston Scientific Implantable Pacemakers and Defibrillators to Elevated Pressure (PDF)

  13. Use of V.A.C.® Therapy and Hyperbaric Oxygen Therapy (PDF, 41KB)

  14. Recall Notification for Sechrist Model IV-100B and IV-200 Ventilators with Electronic Manometers (PDF, 40KB) -- (affected serial numbers can be found here)