FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

Recently Approved Devices

The products listed on this page include some of the newest medical technology available. Each product listing contains information about what medical uses the device is approved for, when it can be used, and when it should not be used.  This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

List by Approval Date - List by Device Name - List by Category of Device

Device Name	Category	Approv.Date	Links
JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Contact Lenses	9/29/2004
Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial)	Defibrillators	9/14/2004
ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators	Hepatitis	9/10/2004
Verisyse™ Phakic IOL	Intraocular Lens (IOL)	9/10/2004
ACCULINK™ and RX ACCULINK™ Carotid Stent System	Stents	8/30/2004
Vertical Expandable Prosthetic Titanium Rib (VEPTR)	Prostheses	8/23/2004
Siemens Mammomat Novation DM Full Field Digital Mammography System	Mammography	8/20/2004
Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody		8/11/2004
ADVIA Centaur® HBc IgM ReadyPack Reagents, ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials	Hepatitis	8/6/2004
Sculptra	Skin Fillers	8/3/2004
CEDIA® Sirolimus Assay	Test Kits	7/28/2004
INTACS® Prescription Inserts for Keratoconus	Corneal Inserts	7/26/2004
Stelid II, Stelix, and Stelix II steroid eluting endocardial pacing leads	Pacing Systems	7/17/2004
bioMerieux VIDAS total PSA assay	PSA	7/8/2004
ImageChecker® CT CAD Software System	Computed Tomography, Lung Cancer	7/8/2004
St. Jude Medical® Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy	Cardioverter, Defibrillators, Implantable Cardioverter Defibrillator	6/30/2004
IntraStent® DoubleStrut™ Stent	Stents	6/8/2004
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Contact Lenses	6/7/2004
Glucatell™	Fungal Infections	5/21/2004
St. Jude Medical Frontier™ Biventricular Cardiac Pacing System	Pacing Systems	5/13/2004
INFUSE® Bone Graft	Bone Graft	4/30/2004
Oculaid™ Capsular Tension Ring, or Stableyes™ Capsular Tension Ring	Cataracts, Intraocular Lens (IOL)	4/27/2004
PRECISION Spinal Cord Stimulator (SCS) System	Spinal, Stimulator	4/27/2004
Hylaform	Skin Fillers	4/22/2004
Oxford™ Meniscal Unicompartmental Knee System	Knee Prostheses	4/21/2004
OP-1 Putty	Spinal, Spinal Fusion	4/7/2004
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System	Stents	3/4/2004
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator	Hepatitis	3/4/2004
Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator	Hepatitis	3/4/2004
DeBakey VAD® Child	Ventricular Assist Device	2/25/2004
Heartsbreath	Heart Devices	2/24/2004
Prolieve™	Benign Prostatic Hyperplasia (BPH), Microwaves	2/19/2004
DakoCytomation EGFR pharmDx™	In Vitro Diagnostics (IVD)	2/12/2004
Abbott AxSYM® Antibody to Hepatitis C Virus	Hepatitis	2/5/2004
AxSym® Free PSA	Prostate, Prostate Cancer, PSA	2/5/2004
Orthovisc® High Molecular Weight Hyaluronan	Sodium Hyaluronate	2/4/2004
CONTAK® RENEWAL™ TR Models H120 and H125	Pacemaker	1/26/2004
CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer	Breast Cancer	1/21/2004
CoSeal™ Surgical Sealant	Sealants	12/12/2003
Restylane™ Injectable Gel	Wrinkle Removers	12/12/2003
Keramos™ Ceramic/Ceramic Total Hip System	Hip Prostheses	11/26/2003
Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported)	Heart Valves	11/21/2003
NIRflex™ Premounted Coronary Stent System	Stents	10/24/2003
Morcher Endocapsular Tension Ring	Intraocular Lens (IOL)	10/23/2003
WaveLight ALLEGRETTO WAVE™ Excimer Laser System	Lasers	10/13/2003
WaveLight ALLEGRETTO WAVE™ Excimer Laser System	LASIK	10/7/2003
Microwave Endometrial Ablation (MEA) System	Ablation Devices, Endometrial, Microwaves	9/23/2003
Blazer II XP Cardiac Ablation Catheter, EPT-1000 XP Cardiac Ablation Controller and Accessories	Cardiac Ablation Devices, Catheters	8/25/2003
INDEPENDENCE™ iBOT™ 3000 Mobility System	Wheelchairs	8/13/2003
S.M.A.R.T.™ Nitinol Stent System and S.M.A.R.T.™ Control™ Nitinol Stent System	Stents	8/12/2003
MULTI-LINK VISION™ RX & OTW Coronary Stent System	Angioplasty, Cardiac Angioplasty Devices, Catheters, Stents	7/16/2003
Dermagraft®	Skin, Skin Substitutes, Wound Healing Devices	7/7/2003
FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty PTCA Catheter	Angioplasty, Cardiac Angioplasty Devices, Catheters	6/11/2003
ThinPrep™ Imaging System	Cervical Cancer, Cervical Cytology, Computer Aided Diagnosis (CADx)	6/6/2003
Zenith AAA Endovascular Graft	Aneurysm Repair Devices, Endovascular Grafts	5/23/2003
Response™ CV Catheter System	Cardiac, Catheters	5/7/2003
CYPHER™ Sirolimus-eluting Coronary Stent	Stents	4/24/2003
Enteryx Procedure Kit	Gastroesophageal Reflux Disease (GERD)	4/22/2003
7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System	Cardiac Ablation Devices	4/17/2003
Medtronic Activa® Dystonia Therapy	Stimulator	4/15/2003
Digene Hybrid Capture 2 High-Risk HPV DNA Test	HPV - Human Papillomavirus	3/31/2003
Bayer Versant™ HCV RNA 3.0 Assay (bDNA)	Hepatitis, Hepatitis C Test Kit	3/28/2003
FemCap	Barrier Devices, Contraceptives	3/28/2003
Medtronic AT500TM DDDRP Pacing System	Pacemaker	3/26/2003
NeedleZap	Hypodermic Needles, Needles, Sharps	3/14/2003
CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen	Collagen, Scarring, Wrinkles	3/11/2003
Ceramic TRANSCEND® Hip Articulation System	Hip Prostheses	2/3/2003
Osteonics® ABC System and Trident™ System	Hip Prostheses	2/3/2003
Dimension® Free Specific Antigen (FPSA) Flex® Reagent Cartridge	Prostate, PSA	1/24/2003
Philips Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Saturation Monitoring	Fetal Oxygen	1/3/2003
ProstaLund® CoreTherm™	Benign Prostatic Hyperplasia (BPH), Prostate, Prostate Cancer	12/23/2002
Bridge™ Extra Support Over-The-Wire Renal Stent System	Angioplasty, Balloon, Renal Stent	12/18/2002
Metrika A1cNow® for Home Use	Diabetes	12/13/2002
Karl Storz Autofluorescence System	Autofluorescence, Bronchoscopes	12/12/2002
ALERT® System	Defibrillators	11/27/2002
Elecsys® proBNP Immunoassay	Congestive Heart Failure	11/19/2002
IDI-Strep B Assay	In Vitro Diagnostics (IVD), Strep B Assay	11/18/2002
VERSANT™ HCV RNA Qualitative Assay	Hepatitis	11/7/2002
EXCLUDER™ Bifurcated Endoprosthesis	Aneurysm Repair Devices	11/6/2002
HeartMate® SNAP-VE LVAS	Heart Devices, Ventricular, Ventricular Assist Device	11/6/2002
Essure™ System	Contraceptives	11/4/2002
NaviStar DS and Celsius DS Diagnostic/Ablation Catheters, Stockert 70 RF Generator and Accessories	Cardiac Ablation Devices	9/27/2002
Neuroform™ Microdelivery Stent System	Aneurysm Repair Devices, Stents	9/11/2002
GlucoWatch G2 Biographer	Diabetes, Glucose Monitoring, Glucowatch	8/26/2002
RetroX Transcutaneous Air Conduction Hearing Aid System	Hearing Aids	8/20/2002
NEUROLINK® System	Balloon, Catheters, Stents	8/9/2002
IMMULITE HBsAg and IMMULITE 2000 HBsAg and Confirmatory Kit	Hepatitis	7/26/2002
IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM	Hepatitis	7/26/2002
IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc	Hepatitis	7/24/2002
IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs	Hepatitis	7/22/2002
Mentor Saline-Filled Testicular Prosthesis	Testicular Prostheses	7/19/2002
Siemens SONOCUR® Basic	Elbow, Extracorporeal, Shock Wave Therapy	7/19/2002
Guidant Ventak Implantable Cardioverter Defibrillators - Expanded Use	Defibrillators, Implantable Cardioverter Defibrillator	7/18/2002
PALMAZ® Balloon-Expandable Stent for Renal Arteries	Angioplasty, Balloon	7/10/2002
InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device	Back Pain, Bone Graft Substitute, Spinal Fusion	7/2/2002
Medtronic® InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator System with Cardiac Resynchronization Therapy	Defibrillators, Implantable Cardioverter Defibrillator	6/26/2002
AFFINITY™ Cage System	Orthopedic	6/13/2002
Paragon CRT™ (paflufocon B), Paragon CRT™ 100 (paflufocon D), Paragon Quadra RG™ (paflufocon B), and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy	Contact Lenses, Eye	6/13/2002
Roche Diagnostics Accu-Check Advantage Module	Glucose Monitoring	6/11/2002
TheraSense, Inc. FreeStyle Tracker™ Diabetes Management System	Glucose Monitoring	6/11/2002
Indermil™ Tissue Adhesive	Glue	5/22/2002
Guidant Cardiac Resynchronization Therapy Defibrillator System	Defibrillators, Implantable Cardioverter Defibrillator	5/2/2002
Ancure® Aortoiliac System	Endovascular Grafts	4/24/2002
INTEGRA® Dermal Regeneration Template	Burns, Collagen, Dermal, Skin	4/19/2002
ViewPoint CK System	Eye Surgery, Lasers	4/11/2002
AMPLATZER® PFO Occluder	Heart Devices, Occlusion Devices, Septal Occluders	4/5/2002
IntraCoil® Self-Expanding Peripheral Stent	Stents	4/3/2002
QuickSeal Arterial Closure System	Heart, Heart Devices, Sealants	3/25/2002
Disintegrator Insulin Needle Destruction Unit	Needles, Sharps	3/15/2002
Lorad Digital Breast Imager	Breast Imaging Devices, Digital Mammography	3/15/2002
Lea's Shield	Contraceptives, Women's Health	3/14/2002
SIR-Spheres®	Cancer, Radioactive Spheres	3/5/2002
Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs	Hepatitis	2/27/2002
Wartner Wart Removal System	Wart Removal	2/20/2002
Second Look™	Breast Imaging Devices, Digital Mammography	1/31/2002
Dornier Epos Ultra	Shock Wave Therapy	1/15/2002
MammoReader	Breast Imaging Devices, Mammography	1/15/2002
Activa® Parkinson's Control System	Brain Stimulator, Movement Disorders, Parkinson's Disease, Stimulator	1/14/2002
VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method	Excimer Lasers	12/19/2001
Acticon™ Neosphincter	Artificial Sphincter	12/18/2001
LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System	Defibrillators	12/18/2001
CoSealTM Surgical Sealant	Sealants	12/14/2001
AMPLATZER® Septal Occluder	Cardiac, Heart, Heart Devices	12/5/2001
NNMT Medical, Inc. CardioSEAL Septal Occlusion System with QwikLoad	Septal Occluders	12/5/2001
BioGlue Surgical Adhesive	Glue	12/3/2001
QuantiFERON® -TB	Tuberculosis	11/28/2001
Genesis Neurostimulation (IPG) System	Stimulator	11/21/2001
Ascension MCP	Finger Joint Implant, Orthopedic	11/19/2001
Gynecare Intergel Adhesion Prevention Solution	Adhesion Prevention, Ob/Gyn, Ob/Gyn Surgical Devices	11/16/2001
WALLSTENT Venous Endoprosthesis with Unistep	Cardiac	11/16/2001
IMMULITE AFP and IMMULTE 2000 AFP	Alpha-Fetoprotein	11/9/2001
OP-1 TM Implant	Bone Implant, Collagen	10/17/2001
Focus Night and Day Soft Contact Lens	Contact Lenses	10/11/2001
Home Monitoring System with the BA03 DDDR Pulse Generator	Pacemaker, Pacing Systems	10/11/2001
DERMAGRAFT	Skin, Skin Substitutes, Wound Healing Devices	9/28/2001
NovaSure™ Impedance Controlled Endometrial Ablation System	Ablation Devices, Endometrial	9/28/2001
SenoScan Full Field Digital Mammography System	Mammography	9/25/2001
Deflux Injectable Gel	Urology, Vesicoureteral Reflux	9/24/2001
Model 3100B High-Frequency Oscillatory Ventilator	Ventilators	9/24/2001
SOUNDTEC® Direct Drive Hearing System	Hearing Devices	9/7/2001
OrCel Bilayered Cellular Matrix	Wound and Burn Dressing	8/31/2001
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator	Hepatitis	8/30/2001
Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis	Finger Joint Implant, Prostheses	8/28/2001
Medtronic InSync Biventricular Pacing System including the InSync Model 8040 Pulse Generator, Attain LV Model 2187 and Attain CS Model 2188 Leads	Pacemaker, Pacing Systems	8/28/2001
MED-EL COMBI 40+ Cochlear Implant System	Hearing Devices	8/20/2001
Given Diagnostic Imaging System	Camera, Diagnostic Imaging, Endoscopy	8/1/2001
UBIS 5000 Ultrasound Bone Sonometer	Bone Sonometers, Orthopedic, Ultrasound	7/17/2001
AquaFlow Collagen Glaucoma Drainage Device - Model CGDD-20	Glaucoma Devices	7/12/2001
RapidScreen RS-2000	Computer Aided Diagnosis (CADx), Lung Cancer, X-Rays	7/12/2001
Integrity AFx DR Model 5346	Pacemaker, Pacing Systems	7/11/2001
AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 (v2.0)	Hepatitis	7/5/2001
Dimension RxL PSA Flex Reagent Cartridge	Prostate, PSA	7/5/2001
COBAS AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 (v2.0)	Hepatitis	7/3/2001
TMx-2000 BPH Thermotherapy System	Microwaves, Prostate	6/29/2001
Carisolv Non-Invasive Caries Removal System	Dental Composites	6/27/2001
Diagnostic Products Corporation’s Total Prostate Specific Antgen (PSA) Assays on the Immulite and Immulite 2000 Analyzers	Prostate	6/19/2001
AMS Sphincter 800™ Urinary Prosthesis	Incontinence, Prostate, Prostate Surgery	6/14/2001
LAP-Band® Adjustable Gastric Banding (LAGB®) System	Gastric Banding, Lap-Band, Obesity, Stomach Band, Weight Loss Devices	6/5/2001
Elecsys HBsAg Immunoassay, Elecsys HBsAg Confirmatory, and PreciControl HBsAg	Hepatitis	6/1/2001
On-X Prosthetic Heart Valve	Heart, Heart Devices, Heart Valves	5/30/2001
Heartstream FR2 AED with Attenuated Defibrillation Pads	Automated External Defibrillators (AED), Defibrillators	5/2/2001
Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit	Hepatitis	4/27/2001
BAK/Cervical (BAK/C) Interbody Fusion System	Orthopedic, Spinal Fusion	4/20/2001
HerOption Uterine Cryoblation Therapy System	Ablation Devices, Cryoblation	4/20/2001
Hydro ThermAblator	Ablation Devices, Endometrial	4/20/2001
STAARVISC Sodium Hyaluronate	Eye Surgery, Sodium Hyaluronate	4/18/2001
Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator System (supplement)	Defibrillators	4/6/2001
CeeOn Edge Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens - Model 911A	Intraocular Lens (IOL)	4/5/2001
Devices for Testing the Hepatitus B Virus (HBV)	Diagnostic Tests, Hepatitis	3/30/2001
PROSTALAC Hip Temporary Prosthesis	Hip Prostheses	3/23/2001
GlucoWatch Automatic Glucose Biographer	Blood Glucose Monitors, Diabetes, Glucose Monitoring, Glucowatch	3/22/2001
N Latex Cystatin C Test Kit	Cystatin C, Diagnostic Tests, In Vitro Diagnostics (IVD)	3/13/2001
Edwards Prima Plus Stentless Bioprosthesis Model 2500P	Heart, Heart Devices, Heart Valves	2/27/2001
TMJ Fossa Eminence Prosthesis	Jaw Surgery, Temporomandibular Joint, Temporomandibular Joint (TMJ) Implants	2/27/2001
Composite Cultured Skin (CCS)	Collagen, Skin, Skin Grafts, Wound Healing Devices	2/21/2001
VISTAKON (lenefilcon A) Soft Contact Lenses	Contact Lenses	2/16/2001
Corometrics 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring	Fetal Oxygen, Monitors	2/9/2001
SUPARTZ Dispo	Sodium Hyaluronate	1/24/2001
TMJ (Temporomandibular Joint) Metal-on-Metal Total Joint Replacement Prostheses System	Temporomandibular Joint (TMJ) Implants	1/5/2001
Microny SR+ Cardiac Pacemaker (Model 245T)	Pacemaker, Pacing Systems	12/21/2000
Q-103 Needle Management System	Anti-Needlestick Devices, Diabetes, Glucose Monitoring, Hypodermic Needles, Needles, Sharps	12/21/2000
Roche Elecsys free Prostate-Specific Antigen (fPSA) Assay on the Elecsys 1010 and 2010 immunoassay analyzers	Analyzer Systems, Prostate, Prostate Cancer, PSA	12/12/2000
Psychemedics Corporation Opiate Assay	Diagnostic Tests, Drugs of Abuse, Test Kits	12/11/2000
Stinger Ablation Catheter and TempLink Extension Cable	Cardiac Ablation Devices, Catheters	11/29/2000
PATHWAY ™ Her 2 (Clone CB11)	Cancer, In Vitro Diagnostics (IVD)	11/28/2000
Roche Elecsys Total Prostate-Specific Antigen (PSA) Assay on the 1010 and 2010 immunoassay analyzers	Analyzer Systems, Prostate, Prostate Cancer, PSA	11/22/2000
Optical Biopsy System	Biopsy Devices, Cancer	11/14/2000
Cordis Checkmate System	Angioplasty, Brachytherapy, Cardiac Angioplasty Devices, Heart, Heart Devices, Restenosis	11/3/2000
Novoste Beta-Cath System	Angioplasty, Brachytherapy, Cardiac Angioplasty Devices, Heart, Heart Devices, Restenosis	11/3/2000
Photon DR Implantable Cardioverter Defibrillator	Defibrillators, Implantable Cardioverter Defibrillator	10/27/2000
Nucleus 24 Auditory Brainstem Implant System	Auditory Implant, Brain Stimulator, Hearing Devices, Stimulator	10/20/2000
BeStent™ 2 with Discrete Technology™ Over-The-Wire and Rapid Exchange Coronary Stent Delivery Systems	Angioplasty, Cardiac Angioplasty Devices, Stents	10/16/2000
ATS Open Pivot Bileaflet Heart Valve	Heart, Heart Devices, Heart Valves	10/13/2000
OssaTron	Orthopedic, Shock Wave Therapy	10/12/2000
BiodivYsio AS PC (phosphorylcholine) Coated Stent Delivery System	Stents	9/29/2000
Phylax AV Implantable Cardioverter Defibrillator with Program Software	Defibrillators, Heart, Heart Devices, Implantable Cardioverter Defibrillator	9/29/2000
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators	Calibrators, In Vitro Diagnostics (IVD)	9/29/2000
TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System	Embolization, Occlusion Devices	9/25/2000
DTU-One Ultrasound Scanner	Bone Sonometers	9/19/2000
Bayer Immuno 1 Complexed Prostate-Specific Antigen (PSA) Assay - P990055	Analyzer Systems, Prostate, PSA	9/8/2000
Medstone STS Lithotripter	Lithotripters	9/5/2000
Vibrant Soundbridge	Hearing Devices	8/31/2000
Horizon 55 EW and Horizon 55 EW Westint Contact Lenses	Contact Lenses	8/22/2000
QUS-2 Calcaneal Ultrasonometer	Bone Sonometers	8/8/2000
Medtronic IsoMed Constant Flow Infusion System	Infusion, Infusion Pumps, Pumps	7/21/2000
Mentor Alpha I Inflatable Penile Prosthesis	Penile Devices	7/14/2000
Mosaic Porcine Bioprosthesis, Model 305 (Aortic) and Model 310 (Mitral)	Heart Valves	7/14/2000
Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens	Contact Lenses	7/11/2000
Diomed 630 PDT Laser Model T2USA	Cancer, Lasers	6/30/2000
Hyperion LTK System	Eye Surgery, Lasers	6/30/2000
Vascular Solutions Duett Sealing Device	Balloon, Sealants	6/22/2000
NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter	Cardiac Ablation Devices, Catheters, Heart, Heart Devices, Radiofrequency Ablation	6/15/2000
Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator System	Defibrillators, Implantable Cardioverter Defibrillator	6/14/2000
CoStasis/DynaStat Surgical Hemostat	Hemostat	6/13/2000
Stocker 70 RF Generator	Cardiac Ablation Devices, Radiofrequency Ablation	5/31/2000
FocalSeal-Synthetic Absorbable Sealant	Sealants	5/26/2000
OxiFirst Fetal Oxygen Saturation Monitoring System	Fetal Oxygen, Monitors, Oxygen	5/12/2000

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH