| FDA
Talk Paper: FDA Issues Guidance on Hospital Bed Design to Reduce Patient
Entrapment |
August 31, 2004
|
| Presentation/Transcript
- American Academy of Pediatrics: Improving the Availability of Pediatric
Devices - June 28, 2004 |
August 31, 2004
|
| Draft
Guidance for Industry and Food and Drug Administration Staff; Hospital Bed
System Dimensional Guidance to Reduce Entrapment |
August 30, 2004
|
| Agenda,
Roster, Questions, and Briefing Material for the August 31, 2004
Orthopaedic and Rehabilitation Devices Panel Meeting |
August 30, 2004
|
| FDA
Clears New Lab Test to Help Screen Newborn Infants for Congenital Disease |
August 27, 2004
|
| Nellcor
Puritan Bennet CO2 Probes Recalled Due to Contamination - Updated Message |
August 27, 2004
|
| Corrections
from August 24 and 23: The Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices Advisory Committee Meeting on Oct.
13th, 2004 has been cancelled. |
August 25, 2004
|
| The
Global Harmonization Task Force Study Group 1 proposed document link was
incorrect. |
August 25, 2004
|
| Announcement
of Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical
Devices Advisory Committee Meeting, Oct. 13th, 2004 |
August 24, 2004
|
| Consumer
Information on: Stelid II, Stelix, and Stelix II steroid eluting
endocardial pacing leads |
August 23, 2004
|
| Consumer
Information on: St. Jude Medical Frontier(tm) Biventricular Cardiac Pacing
System |
August 23, 2004
|
| FDA
Talk Paper: FDA Notifies Patients of Mammography Problems at Ecumed Health
Group Facility in Hialeah, Florida |
August 23, 2004
|
| FDA/CDRH
Annual Report for FY 2003 |
August 23, 2004
|
| Consumer
Information on: ImageChecker(r) CT CAD Software System (Model LN-1000) |
August 18, 2004
|
| Consumer
Information on: Sculptra |
August 18, 2004
|
| MDUFMA:
FY 2005 User Fee Summary |
August 13, 2004
|
| Consumer
Information on: bioMerieux VIDAS total PSA assay |
August 13, 2004
|
| Announcement
of Circulatory System Devices Panel of the Medical Devices Advisory
Committee Meeting, Sept. 21st, 2004 |
August 12, 2004
|
| OIVD
Letter: To Manufacturers of Antimicrobial Susceptibility Tests in which
FDA Clarifies its Position Regarding the Specific Actions that Must be
Taken to Minimize the Risk of Failing to Reliably Detect Vancomycin
Resistant S. aureus (VRSA). |
August 12, 2004
|
| Invitation
to Manufacturers of Infusion Pumps |
August 11, 2004
|
| PMA
Final Decisions for July 2004 |
August 11, 2004
|
| FDA
Seeks Injunction Against Utah Medical Device Manufacturer |
August 10, 2004
|
| Class
1 Medical Device Recall - Shiley Tracheosoft Tracheostomy Tube and
Disposable Inner Cannula |
August 9, 2004
|
| Summary
Information for: Vitros Immunodiagnostic Products Anti-HBc IgM Reagent
Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator -
P030026 |
August 9, 2004
|
| Summary
Information for: SCULPTRA(tm) - P030050 |
August 9, 2004
|
| FDA
News: FDA Approves Sculptra for HIV Patients |
August 9, 2004
|
| 510(k)s
Final Decisions Rendered for July 2004 |
August 9, 2004
|
| Sponsor's
Briefing Information for the Circulatory System Devices Panel Meeting -
July 29, 2004 |
August 5, 2004
|
| Summary
Information on: Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and
Vitros Immunodiagnostic Products Anti-HBc Calibrator - P030024 |
August 4, 2004
|
| Summary
Information on: VIDAS TPSA Assay - P040008 |
August 4, 2004
|
| Summary
Information on: CureLight BroadBand (Model CureLight 01) - P010061 |
August 4, 2004
|
| Circulatory
System Devices Panel Meeting Summary - July 28 & 29, 2004 |
August 3, 2004
|
| OIVD
Letter: To: Correlogic Systems, Inc. Re: OvaCheck(tm) |
August 2, 2004
|
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