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- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020
- Subject(s):
- Device Approval
Suture Anchors
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020
- Subject(s):
- Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020
- Subject(s):
- Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
- Subject(s):
- Bone Screws -- standards
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
- Subject(s):
- Device Approval
Sutures -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
- Subject(s):
- Device Approval
Equipment Safety
Fracture Fixation
Orthopedic Fixation Devices -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, June 16, 2022
- Subject(s):
- Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
- Subject(s):
- Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, February 5, 2019
- Subject(s):
- Device Approval
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
- Subject(s):
- Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
- Subject(s):
- Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, June 27, 2019
- Subject(s):
- Device Approval
Transducers
Ultrasonography -- instrumentation
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
- Subject(s):
- Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
- Subject(s):
- Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- White, Robert S., (Compliance Attorney and member of the Oklahoma Bar), author
- Publication:
- [Toronto, Ontario] : Thomson Reuters, 19-December-2022
- Subject(s):
- Device Approval
Product Surveillance, Postmarketing
Equipment Safety
Medical Device Recalls -- legislation & jurisprudence
United States
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
- Subject(s):
- Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States