| Patient
Safety Portal |
May 29, 2003
|
| Summary
from the 5/23/03 Ophthalmic Devices Panel Meeting |
May 29, 2003
|
| Agenda,
Roster, Questions, and Briefing Material for the 5/29/03 Circulatory
System Devices Panel Meeting |
May 29, 2003
|
| Summary
from the 5/22/03 Dental Products Panel Meeting |
May 23, 2003
|
| Presentations
from the IVD Roundtable 510(k) Workshop held on April 22-23, 2003 |
May 23, 2003
|
| Consumer
Information on NeedleZap(tm) |
May 22, 2003
|
| MOU
- Procedures for Listing Medical Devices and In Vitro Diagnostic Products
Exempted from Premarket Notification [510(k)] on the Internet |
May 22, 2003
|
| CDRH
Ombudsman's Annual Report for Calendar Year 2002 |
May 21, 2003
|
| Announcement
of Extension of Comment Period for Docket No. 03N-0169 Dental Amalgam;
Request for Information |
May 21, 2003
|
| Questions,
Roster and Briefing Information for the 5/23 Ophthalmic Devices Panel
Meeting |
May 20, 2003
|
| FDA
Clears Rapid Test for Aspergillus Infection |
May 20, 2003
|
| Mammography
Facility Adverse Event and Action Report 2002 |
May 19, 2003
|
| PMA
Final Decisions for April 2003 |
May 19, 2003
|
| FDA
Approves Lower Cost Implantable Defibrillator |
May 15, 2003
|
| FY
2003 MDUFMA Fee Payment Instructions |
May 15, 2003
|
| Medical
Device Tracking - Guidance for Industry and FDA Staff |
May 13, 2003
|
| Consumer
Information on CosmoDerm 1 Human-Based Collagen, CosmoDerm 2 Human-Based
Collagen and CosmoPlast Human-Based Collagen - P800022/S050 |
May 12, 2003
|
| Transcript
from the 4/28/03 National Mammography Quality Assurance Advisory Meeting |
May 12, 2003
|
| Agenda,
Panel Questions and Briefing Material for the 5/22/03 Dental Products
Panel Advisory Committee Meeting - Now Available |
May 12, 2003
|
| May-June
Issue of FDA Consumer Magazine - Now Available |
May 12, 2003
|
| FTC
and FDA Crackdown on Internet Marketers of Bogus SARS Prevention Products |
May 12, 2003
|
| Summary
Information for - Medtronic AT500 DDDRP Pacing System (Model AT501) and
Model 9968 Software - P010055 |
May 9, 2003
|
| Summary
Information for - ProstaLund(r) CoreTherm System Microwave Thermotherapy
for BPH - P010055 |
May 9, 2003
|
| FDA
Seeks Injunction Against Multidata Systems Intl (5/8/03) |
May 9, 2003
|
| Article:
Mammography Equipment Evaluations and the Annual Survey - Is Your
Equipment Up to the Task? |
May 7, 2003
|
| MQSA
Facility Scorecard / National Statistics - Updated |
May 7, 2003
|
| Information
on Medical Device Class 1 Recall: Disetronic D-TRON Insulin Infusion Pump
(Recall Initiated 6/17/2002) |
May 6, 2003
|
| Consumer
Information on Medtronic Activa(r) Dystonia Therapy |
May 5, 2003
|
| 510(k)s
Final Decisions Rendered for April 2003 |
May 5, 2003
|
| Announcement
of Upcoming Meeting of the Obstetrics and Gynecology Devices Panel - June
9-10, 2003 |
May 5, 2003
|
| Premarket
Approval Application Filing Review - Guidance for Industry and FDA Staff |
May 2, 2003
|
| The
upcoming Mid-Year Stakeholder Meeting on the Implementation of MDUFMA
Provisions (6/6/03) has been postponed. A new date and time will be
announced as soon as the meeting is rescheduled. |
May 1, 2003
|
| FDA
Clears New Breath Test for Monitoring Asthma |
May 1, 2003
|
| Lab
Safety Tip - Functions and Limitations of Built-in Controls for Single Use
Disposable Tests |
May 1, 2003
|
| Lab
Safety Tip - Common Problems with the Use of Glucose Meter |
May 1, 2003
|
| Summary
Information for - Healthtronics OssaTron(r)- P990086/S003 |
May 1, 2003
|
| FDA
Patient Safety News - May Edition - Now Available |
May 1, 2003
|
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