| CDRH
Ombudsman's Annual Report for Calendar Year 2003 |
March 31, 2004
|
| FDA
Public Health Notification: Safety Tips for Preventing Hospital Bed Fires
- UPDATED |
March 31, 2004
|
| Consumer
Information on: AxSYM(r) Free PSA |
March 30, 2004
|
| Transcript
from the March 5, 2004 Ophthalmic Devices Panel Meeting |
March 30, 2004
|
| FDA
News: FDA Approves First Oral Fluid Based Rapid HIV Test Kit |
March 26, 2004
|
| Class
1 Medical Device Recalls: VITEK GPS-107 Cards |
March 26, 2004
|
| Consumer
Information on: Abbott AxSYM® Antibody to Hepatitis C Virus |
March 23, 2004
|
| OIVD
News: bioMèrieux, Inc. Recalls the VITEK GPS-107 Gram Positive
Susceptibility Card, lot M58X and FDA Classifies this Voluntary Action
as a Class I Recall |
March 23, 2004
|
| OIVD
News: FDA Recommends that Ventana Medical Systems, Inc. Submit a
Premarket Approval Application (PMA) for Their Marketed Automated
INFORM® Human Papillomavirus (HPV) In-Situ Hybridization (ISH)
Diagnostic Test System |
March 23, 2004
|
| Summary
Information for: ViewPoint(tm) CK® System - P010018/S005 |
March 23, 2004
|
| Panel
Roster for the March 25, 2004 General and Plastic Surgery Devices Panel
Meeting |
March 23, 2004
|
| Medical
Device Reports; Reports of Corrections and Removals; Establishment
Registration and Device Listing: Premarket Approval Supplements; Quality
System Regulation; Importation of Electronic Products; Technical Amendment |
March 16, 2004
|
| Consumer
Information on: Heartsbreath - H030004 |
March 16, 2004
|
| Consumer
Information on: Heartsbreath - H030004 |
March 10, 2004
|
| Consumer
Information on the DeBakey VAD(r) Child - H030003 |
March 10, 2004
|
| Notice
of Upcoming Meeting of the Circulatory System Devices Panel - April 21,
2004 |
March 10, 2004
|
| Brief
Summary from the March 5, 2004 Ophthalmic Devices Panel Meeting |
March 10, 2004
|
| Summary
Information for: Prolieve(tm) Thermodilatation System - P030006 |
March 9, 2004
|
| X-Ray
Assembler Data - Updated |
March 9, 2004
|
| OIVD
News: FDA Law Allows for Electronic Labeling if Users May Still Request
Labeling in Paper Form |
March 9, 2004
|
| Medical
Device Recalls, Class 1 Recall: Faaborg Patient Lifts |
March 8, 2004
|
| Agenda,
Participants and Briefing Information for the March 5, 2004 Ophthalmic
Devices Panel Meeting |
March 4, 2004
|
| Brochure
- Home Healthcare Medical Devices: Blood Glucose Meters - Getting the Most
Out of Your Meter |
March 3, 2004
|
| FDA
Patient Safety News - March Edition |
March 1, 2004
|
| Summary
of Safety and Probable Benefit for: DeBakey VAD Child Left Ventricular
Assist System - H030003 |
March 1, 2004
|
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