| Consumer
Information on: Diagnostic Products Corporation's Total Prostate Specific
Antigen (PSA) Assays on the Immulite and Immulite 2000 Analyzers |
September
28, 2001
|
| Notice
of Upcoming Meeting of the Clinical Chemistry/Clinical Toxicology Devices
Panel on 10/29/01 |
September
28, 2001
|
| Consumer
Information on: COBAS AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0
(v2.0) |
September
25, 2001
|
| Consumer
Information on: AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) |
September
25, 2001
|
| Summary
Information for HerOption Uterine Cryoblation Therapy System - P000032 |
September
24, 2001
|
| Consumer
Information on: Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis |
September
24, 2001
|
| Summary
Information for SOUNDTEC® Direct System - P010023 |
September
20, 2001
|
| Summary
Information for OrCelTM Bilayered Cellular Matrix - P01001 |
September
20, 2001
|
| Consumer
Information on: OrCelTM Bilayered Cellular Matrix - P010016 |
September
20, 2001
|
| Consumer
Information on: TMx-2000TM BPH Thermotheraphy System - P000043 |
September
20, 2001
|
| Recall
of Zirconia Ceramic Femoral Heads for Hip Implants |
September
14, 2001
|
| Summary
for the 9/10-9/11/01 Circulatory System Devices Panel Meeting |
September
14, 2001
|
| Talk
Paper: Hip Implants Being Recalled |
September
14, 2001
|
| Recall
of Zirconia Ceramic Femoral Heads for Hip Implants |
September
13, 2001
|
| Summary
for Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis - H010001 |
September
13, 2001
|
| Summary
from the Medical Devices Dispute Resolution Panel Meeting of 9/6/01 |
September
13, 2001
|
| Premarket
Approval Decisions Rendered for August 2001 |
September
12, 2001
|
| Consumer
Information on Composite Cultured Skin (CSS)- H990013 |
September
12, 2001
|
| Information
for Day 2 of the Circulatory System Devices Panel Meeting - September 11,
2001 |
September
10, 2001
|
| Agenda |
|
| Briefing
Information |
|
| Questions
Part 1 |
|
| Questions
Part 2 |
|
| Agenda
and Briefing
Information for the 9/10/01 Circulatory System Devices Panel Meeting |
September
7, 2001
|
| CLIA:
List of Tests Waived-Updated |
September
7, 2001
|
| CLIA:
List of Analytes Waived - Updated |
September
7, 2001
|
| Now
Available: CLIA Database for Downloading |
September
7, 2001
|
| Presentation:
FDA's Final Policy on Single-Use Devices (SUDs) Reprocessed by Third Parties
and Hospitals |
September
7, 2001
|
| Former
Medical Device Company Official Sentenced to 10 Months for Fraud |
September
7, 2001
|
| 510(k)
Decisions Rendered for August 2001 |
September
7, 2001
|
| Summary
Information for Edwards Prima Plus Stentless Bioprosthesis Model 2500P -
P000007 |
September
5, 2001
|
| Summary
Information for Omnicarbon Cardiac Valve Prosthesis - P 830039S7 |
September
5, 2001
|
| Briefing
Information for the September 6, 2001 Meeting of the Medical Devices Dispute
Resolution Panel |
September
5, 2001
|
| User
Facility Reporting Bulletin Summer 2001 - Now Available |
September
5, 2001
|
| Consumer
Update - DEHP in Plastic Medical Devices |
September
5, 2001
|
| Safety
Assessment of di-(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical
Devices |
September
5, 2001
|
|
|
