| Orthopedic
Devices: Reclassification of the Hip Joint Metal/Polymer Constrained Cemented
or Uncemented Prosthesis |
April
30, 2002
|
| Consumer
Information on: Genesis Neurostimulation (IPG) System |
April
29, 2002
|
| Class
II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve;
Guidance for Industry and FDA |
April
29, 2002
|
| Presentation:
FDA's CLIA Complexity Process |
April
29, 2002
|
| Whole
Body Scanning Using Computed Tomography (CT) |
April
26, 2002
|
| Alternative
Summary Reporting |
April
26, 2002
|
| Summary
Information on Lorad Digital Breast Imager - P010025 |
April
25, 2002
|
| Summary
Information on ViewPoint(tm) CK System- P010018 |
April
25, 2002
|
| Summary
Information on Elecsys® Anti-HBs Immunoassay and Elecsys® Anti-HBs
PreciControl - P010054 |
April
25, 2002
|
| Summary
Information on PathVysion(tm); HER-2 DNA Probe Kit - P980024s001 |
April
25, 2002
|
| Summary
from the 4/22/02 Obstetrics and Gynecology Devices Panel Meeting |
April
24, 2002
|
| New
Products to Treat Diabetes - FDA Helps Counter a Major Public Health Threat |
April
24, 2002
|
| FDA
Approves Reconstructive Surgery Product for Patients With Severe Scarring |
April
23, 2002
|
| List
of Distributors for A & A Medical, Inc. (Recall) - Updated |
April
23, 2002
|
| Summary
of Safety and Probably Benefit for AMPLATZER ® PFO Occluder - H000007 |
April
22, 2002
|
| Manufacturer
and User Facility Device Experience Database (MAUDE) - Now Updated |
April
22, 2002
|
| List
of Over-the-Counter IVDs (Updated) |
April
22, 2002
|
| Draft
Questions, Roster, Agenda and Briefing Material for the April 22, 2002 Obstetrics
and Gynecology Devices Panel Meeting |
April
19, 2002
|
| Consumer
Information on SOUNDTEC® Direct Drive Hearing System |
April
19, 2002
|
| Consumer
Information on Lorad Digital Breast Imager |
April
18, 2002
|
| Consumer
Information on: QuickSeal Arterial Closure System |
April
18, 2002
|
| Consumer
Information on: SIR-Spheres® |
April
18, 2002
|
| Notice
of Upcoming Tissue Engineered Medical Products Standards (TEMPS) Teleconference
- May 9, 2002 |
April
18, 2002
|
| Notice
of ASTM - Tissue Engineered Medical Products Standards (TEMPS) Symposium
November 4-5 2002 |
April
18, 2002
|
| Urgent
Device Recall Letter sent to Distributors and Customers of Ob/Gyn and Surgical
Products Manufactured by A & A Medical/Rocket USA/Lifequest |
April
17, 2002
|
| List
of Distributors for A & A Medical, Inc. (Recall) |
April
17, 2002
|
| Notice
of Upcoming Tissue Engineered Medical Products Standards (TEMPS) Teleconference
- May 9, 2002 |
April
17, 2002
|
| Notice
of ASTM - Tissue Engineered Medical Products Standards (TEMPS) Symposium
November 4-5 2002 |
April
17, 2002
|
| Summary
Information on LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000
System - P010030 |
April
12, 2002
|
| Notice
of Upcoming Meeting of the Technical Electronic Products Radiation Safety
Standards Committee - May 22, 2002 |
April
11, 2002
|
| Consumer
Information on: CoSeal(tm) Surgical Sealant |
April
11, 2002
|
| Transcript
of the 3/7-8/2002 Microbiology Devices Panel Meeting Now Available |
April
9, 2002
|
| FDA
Patient Safety News - New Broadcast Available |
April
8, 2002
|
| CDRH
Contacts Listing |
April
2, 2002
|
| Third
Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition
Agreement (MRA) |
April
2, 2002
|
|
|
