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H C F A- Health Care Financing Administration
	Health Care Financing Administration (HCFA) - see Centers for Medicare & Medicaid Services (CMS)
Hair Removal
	Hair Removal Laser Facts
Hand Implants
	FDA Approves New Hand Implant for Quadriplegics
HDE
	Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
	HDE - See Humanitarian Device Exemptions
Health Advisories
	Health Advisories and Safety Alerts
Health Fraud
	Agencies Team Up In War Against Internet Health Fraud
	An FDA Guide to Choosing Medical Treatments
	FDA Joins with FTC & Others Against Internet Health Fraud
Health Professionals
	FDA Patient Safety News
Hearing Aids
	Guidance for Industry; Noise Claims in Hearing Aid Labeling; Final
	Implantable Middle Ear Hearing Device; Guidance for Industry and FDA
Hearing Devices
	Brain stem implant to restore some hearing when tumors damage the cranial hearing nerves
	Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA
	FDA Approves New Implanted Hearing Device
	FDA Plans to Strengthen Hearing Aid Rules
	Implantable Middle Ear Hearing Device; Guidance for Industry and FDA
	Message Sent Loud and Clear to Hearing Aid Marketer
	Nucleus ® 24 Auditory Brainstem Implant System
	On the Teen Scene: Enjoy, Protect, the Best Ears of Your Life
	Straight Talk from FDA About Hearing Loss and Hearing Aids
	Testing of Hearing Aid Interference from Digital Cellular Telephones
Heart
	Carpenter-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral - P860057/S011
	Cordis Checkmate System
	FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients
	FDA Clears 3-lead, pocket-sized ECG devices
	FDA Clears Lab Test for Congestive Heart Failure
	FDA Clears New Interventional Cardiology Device
	FDA Clears New Lab Test to Help Rule Out Heart Attack
	FDA Heart Health Online
	FDA Speeds Approval for WiderUse of Heart Attack Device
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	Medtronic® InSync® Biventricular Pacing System including the InSync® Model 8040 Pulse Generator, Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter
	Novoste Beta-Cath System
	Phylax AV Implantable Cardioverter Defibrillator with Program Software
	Pocket-Sized ECG Machine Cleared By FDA
	Syncardia Temporary CardioWest™ Total Artificial Heart (TAH-t)
Heart Attack
	FDA Clears New Lab Test to Help Rule Out Heart Attack
Heart Devices
	Carpenter-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral - P860057/S011
	Cordis Checkmate System
	FDA Approves First Totally Implanted Permanent Artificial Heart for Humanitarian Uses
	FDA Approves Heart Assist Pump for Permanent Use
	FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients
	FDA Clears 3-lead, pocket-sized ECG devices
	FDA Clears New Interventional Cardiology Device
	FDA Clears Robotic-Like Device for Heart Surgery
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	Medtronic® InSync® Biventricular Pacing System including the InSync® Model 8040 Pulse Generator, Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter
	Novoste Beta-Cath System
	Phylax AV Implantable Cardioverter Defibrillator with Program Software
	Pocket-Sized ECG Machine Cleared By FDA
Heart Valves
	Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.
	Preliminary Advice for Patients: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Medical Devices Manufactured by Shelhigh, Inc.
	Questions & Answers on Shelhigh Medical Devices
Heating and Cooling Devices
	Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
	Heating Devices - How to Avoid Burns
	Questions and Answers on Chattem, Inc. Icy Hot Heat Therapy Air Activated Heat (Back and Arm, Neck & Leg)
	Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety
Helicobacter Pylori
	Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori
Help
	Device Advice: the CDRH self-service site for medical device and radiation emitting product information
Hemodialysis
	FDA Class I Classification Given to Baxter’s September 2005 Urgent Product Recall for Meridian Hemodialysis Instrument
	Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final
	Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis
	Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final
	Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis
	Important Information Relating to Cellulose Acetate Dialyzers
	Manufacturers and Initial Distributors of Hemodialyzers
	Potential Cross-Contamination Linked To Hemodialysis Treatment
	Prevent Dangerous Hemodialysis Catheter Disconnections
	Quality Assurance Guidelines for Hemodialysis Devices
	Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
Hemostasis Devices
	Collagen Hemostasis Devices - Small Device, Big Risk
	Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use - Phase II
Hemostatic Agents
	Paralysis from Absorbable Hemotatic Agent
Hepatitis
	Abbott AxSYM® Antibody to Hepatitis C Virus
	ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials
	FDA Talk Paper - FDA Approves First Home Test For Hepatitis C Virus
	Hepatitis C Home Use Test
	Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe
Hepatitis C Test Kit
	Hepatitis C Home Use Test
Hernias
	Information on Surgical Mesh for Hernia Repairs
Hip Prostheses
	Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis
	Guidance Document For The Preparation of Premarket NotificationFor Ceramic Ball Hip Systems
	Recall of Zirconia Ceramic Femoral Heads for Hip Implants
	Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses
	Talk Paper: Hip Implants Being Recalled
HIV
	FDA Approves First Oral Fluid Based Rapid HIV Test Kit
	FDA Approves Sculptra for HIV Patients
	Frequently Asked Questions About The Oraquick® Rapid HIV-1 Antibody Test
	HIV Home Use Test
Home Healthcare Devices
	Brochure - Home Healthcare Medical Devices: Blood Glucose Meters - Getting the Most Out of Your Meter
	Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump
	Brochure: Home Healthcare Medical Devices: A Checklist
	CDRH Home Health Care Committee
	Emerging Trends in Medical Device Technology: Home is Where the Heart Monitor Is
Home Monitors
	Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers
	Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests
Home Test Kits
	FDA Proposes New Policy for Home Drug Abuse Test Kits
	Over The Counter In Vitro Diagnostic Devices
Hospital Beds
	A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment
	FDA Asks U.S. Marshals to Seize Adulterated and Misbranded Hospital Bed Systems
	Safety Tips for Preventing Hospital Bed Fires
Hospitals
	Hospital Compare - A quality tool for adults, including people with Medicare
HPV - Human Papillomavirus
	FDA Approves Expanded Use of HPV Test
Human Allograft Tissue
	FDA Issues Order to Recall Use of Human Tissue Processed at Cryolife, Inc.
Human Chorionic Gonadotropin (hCG)
	Blood Human Chorionic Gonadotropin (hCG) Assays: What Laboratorians Should Know about False-Positive Results
	Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s
	Kit Certification for 510(k)s
	Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
Human Factors
	Checklist: Make Sure the Medical Device You Choose Is Designed for You
	Draft Report on Medical Device Labeling: Patients' and Lay Caregivers' Medical Device Information and Labeling Needs - Results of Qualitative Research
	Human Factors Program
	Introduction to Human Factors and the Human Factors Engineering Group
	Questions and Answers from the 2/14/2001 Teleconference: Integrating Human Factors Engineering into Medical Device Design and Development
	Reducing Use Error
Human Tissue
	FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc.
Humanitarian Use Devices
	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
	Fetal Stent Receives First Humanitarian Use Approval
	Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
	HDE - See Humanitarian Device Exemptions
	Humanitarian Use Devices
	Humanitarian Use Devices (HDE) Checklist for Filing Decision
Humidifiers
	Hazards of Volume Ventilators and Heated Humidifiers
	Heated Humidifier Review Guidance
Humidity
	Hurricanes: Health and Safety Before and After a Storm
Hurricane Disasters
	Disposal of Contaminated Devices - Notice to Pharmacy Owners and FDA Inspectors
	FDA Offers Advice About Reopening Dialysis Centers After Restoration of Power and Water
	FDA Offers Tips about Medical Devices and Hurricane Disasters
	Health and Safety After Hurricanes
	Hurricanes: Health and Safety Before and After a Storm
	In Aftermath of Hurricane, FDA Advice for Medical Devices that Require Refrigeration
	Information About Medical Devices and Disasters
	Medical Devices that Have Been Exposed to Heat and Humidity
Hyalgan/Synvisc Knee Injection For Osteoarthritis
	Hyalgan
	Synvisc
Hybridization
	Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)
Hydrobaths
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths
Hydroxyapatite
	510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants
Hypodermic Needles
	Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
	NeedleZap
Hysteroscopes
	Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices
	Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)
	Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k)

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