| Code | Device name | Class | 21 CFR | 510(k) (3y) |
|---|
| OLS | Oral Wound Dressing W/Drug And/Or Biologic | Class U | | |
| OME | Extracorporeal Shock Wave Treatment | Class 3 | | |
| OMX | High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented | Class F | | |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Class 3 | | |
| OOB | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter | Class 3 | | |
| OOY | Bronchial Thermoplasty System | Class 3 | | |
| OPR | Intrasaccular Flow Disruption Device | Class 3 | | |
| OQS | Laboratory Developed Test | Class N | | |
| ORL | Whole Blood Pre-Treatment T-Cell Enrichment Reagent | Class 3 | | |
| OSR | Pacemaker/Icd/Crt Non-Implanted Components | Class 3 | | |
| OTE | Digital Breast Tomosynthesis | Class 3 | | |
| OTL | Femtosecond Laser System For Refractive Correction | Class 3 | | |
| OTQ | Research Use Only/Hematology Devices | Class N | | |
| OTR | Research Use Only/Immunology Devices | Class N | | |
| OTT | Research Use Only/Microbiology | Class N | | |
| OTU | Research Use Only/Pathology | Class N | | |
| OTV | Research Use Only/Clinical Chemistry Devices | Class N | | |
| OTW | Research Use Only/Clinical Toxicology | Class N | | |
| OUT | Intracranial Aneurysm Flow Diverter | Class 3 | | |
| OUU | Polymeric Neurovascular Embolization | Class F | | |
| OVC | Headframe | Class N | | |
| OVG | Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used | Class F | | |
| OVL | Hemodialyzer, High Cut-Off | Class F | | |
| OVO | Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation | Class 3 | | |
| OVX | Water Immersion Labor Pool | Class N | | |
| OWD | Somatic Gene Mutation Detection System | Class 3 | | |
| OWE | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene R | Class 3 | | |
| OWO | Drug-Eluting Sinus Stent | Class 3 | | |
| OXR | 5-Fluorouracil Assay | Class N | | |
| OXW | Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy | Class N | | |
| OYA | P2psa | Class 3 | | |
| OYB | Kit, Rna Detection, Human Papillomavirus | Class 3 | | |
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | Class 3 | | |
| OYF | Aspiration Therapy System | Class 3 | | |
| OYM | Prostrate Cancer Genes Nucleic Acid Amplification Test System | Class 3 | | |
| OYR | Filler, Bone Void, Recombinant Platelet-Derived Growth Factor | Class N | | |
| OYY | Leukemia Translocation Panel Multiplex Test | Class N | | |
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Class 3 | | |
| OZG | Transcatheter Septal Occluder (Atrial) | Class 3 | | |
| OZH | Transcatheter Septal Occluder (Ventricular) | Class 3 | | |
| OZJ | Inhibitor, Postoperative Fibrosis (Adhesion Barrier) | Class N | | |
| OZO | Automated Insulin Dosing , Threshold Suspend | Class 3 | | |
| OZP | Automated Insulin Dosing Device System, Single Hormonal Control | Class 3 | | |
| OZQ | Automated Insulin Dosing Device System, Bihormonal Control | Class 3 | | |
| PAA | Automated Breast Ultrasound | Class 3 | | |
| PAN | Braf Mutation Kit | Class N | | |
| PAP | Aortic Heart Valve, More Than Minimally Manipulated Allograft | Class F | | |
| PAQ | Test, Nr2 Antibody | Class N | | |
| PAR | Test, Volatile Organic Compounds Breath Analysis | Class F | | |
| PAS | Rf/Microwave Hyperthermia System, Cancer Treatment | Class F | | |
| PAT | Bladder System | Class F | | |
| PAX | Surgical Kit | Class F | | |
| PAZ | Electrical Stimulation Bladder System | Class F | | |
| PBA | Ecarin Clotting Time | Class F | | |
| PBN | Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients | Class F | | |
| PBU | Bone Void Filler, Syringe | Class N | | |
| PCQ | Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier) | Class N | | |
| PCW | Implantable Pulse Generator, Programmer And Battery Charger | Class N | | |
| PCX | Artificial Chordae Tendinae Delivery System | Class N | | |
| PCY | Investigational Use Only - Microbiology | Class N | | |
| PCZ | Investigational Use Only - Immunology | Class N | | |
| PDA | Investigational Use Only - Clinical Chemistry | Class N | | |
| PDB | Investigational Use Only - Clinical Toxicology | Class N | | |
| PDC | Investigational Use Only - Hematology | Class N | | |
| PDD | Investigational Use Only - Pathology | Class N | | |
| PDI | Beta 2-Microglobulin Apheresis Column | Class F | | |
| PDR | Computer-Assisted Personalized Sedation System | Class 3 | | |
| PEJ | Salivary Estriol Test | Class 3 | | |
| PEP | Molecular Erythrocyte Typing Test | Class 3 | | |
| PFC | Cultured Human Cell Skin Dressing | Class 3 | | |
| PFE | Gastrointestinal Liner System | Class N | | |
| PFM | Hemibridge System | Class N | | |
| PFN | Implanted Brain Stimulator For Epilepsy | Class 3 | | |
| PFU | Tissue Processing Kit | Class N | | |
| PFV | System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit | Class 3 | | |
| PFZ | Ophthalmic Sealant | Class 3 | | |
| PGE | Gastric Emptying Breath Test | Class 3 | | |
| PGO | Anti-Stick Glass Syringe | Class N | | |
| PGQ | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amp | Class 3 | | |
| PHK | Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/ | Class N | | |
| PHN | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | Class U | | 5 |
| PHO | Normothermic Preservation System For Transplantation Of Initially Unac | Class 3 | | |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | Class 3 | | |
| PHU | Intra-Abdominal Pressure Monitoring Device | Class U | | 2 |
| PIK | Metabolic Neuromodulation System | Class N | | |
| PIL | Test For Periprosthetic Joint Infection | Class N | | |
| PIM | Neuromodulator For Obesity | Class 3 | | |
| PIX | Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Pros | Class N | | |
| PIZ | Combination Compression/Decompression Manual Chest Pump With Impedance | Class 3 | | |
| PJF | Illuminator System For Blood Products | Class 3 | | |
| PJG | Cancer-Related Germline Gene Mutation Detection System | Class 3 | | |
| PJQ | Agent, Occluding, Vascular, Permanent | Class 3 | | |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Class 3 | | |
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Ampute | Class 3 | | |
| PKF | D And C Tray | Class N | | |
| PKJ | Crown And Bridge Material, Resin Based | Class N | | |
| PKK | Stent Delivery System | Class N | | |
| PKM | Chemiluminescent Immunoassay System | Class N | | |
| PKW | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase | Class 3 | | |
| PKY | Implant, Dermal, For Aesthetic Use In The Hands | Class 3 | | |
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | Class 3 | | |
| PMH | Mechanical Compression Device Fecal Incontinence (Non-Manually Operate | Class F | | |
| PMI | Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Rec | Class 3 | | |
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | Class 3 | | |
| PNC | Catheter Introducer | Class N | | |
| PNF | Aortic Stent | Class 3 | | |
| PNK | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) | Class 3 | | |
| PNW | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant | Class 3 | | |
| PNY | Absorbable Coronary Drug-Eluting Stent | Class 3 | | |
| POA | Reagents, Zika Virus Nucleic Acid | Class N | | |
| POG | Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2 | Class N | | |
| POH | Mr-Guided Focused Ultrasound System | Class 3 | | |
| POI | Lung Tissue Sealant For Lung Volume Reduction | Class N | | |
| POT | Lockbox (Export Only) | Class N | | |
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | Class 3 | | |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant | Class 3 | | |
| PRC | Drug-Coated Peripheral Transluminal Angioplasty Catheter | Class 3 | | |
| PRF | Docetaxel / Paclitaxel Assay | Class N | | |
| PRL | Iliac Covered Stent, Arterial | Class 3 | | |
| PSR | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | Class 3 | | |
| PSS | Minoxidil Sulfotransferase Or Isoenzymes Test System | Class N | | |
| PUV | Lymph Node Location System During Sentinel Biopsy Procedure | Class 3 | | |
| PWC | General Wellness Product | Class N | | |
| PWG | Spinal Fixation System | Class N | | |
| PYS | Zika Virus Serological Reagents (Emergency Use) | Class N | | |
| PZC | Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue | Class N | | |
| PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-In | Class 3 | | |
| PZN | Placental Growth Factor Test | Class N | | |
| PZT | Peripheral Blood Processing Device For Osteoarthritis | Class N | | |
| PZU | Bone Marrow Processing Device For Clinical Use | Class N | | |
| PZV | Peripheral Blood Processing Device For Clinical Use | Class N | | |
| QAN | Stent, Iliac Vein | Class 3 | | |
| QBA | Normothermic Machine Perfusion System For The Preservation Of Standard | Class 3 | | |
| QBB | Placental Alpha Microglobulin-1 Immunoassay | Class 3 | | |
| QBG | Assay, Oral Direct Thrombin Inhibitor | Class N | | |
| QBI | Acute Coronary Syndrome Event Detector | Class 3 | | |
| QBT | Artificial Iris | Class 3 | | |
| QCA | Intracranial Coil-Assist Stent | Class 3 | | |
| QCD | Continuous Glucose Monitor, Implanted, Adjunctive Use | Class 3 | | |
| QCG | Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone | Class N | | |
| QCT | Scaffold, Dissection Repair | Class 3 | | |
| QCZ | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension | Class 3 | | |
| QES | Reherniation Reduction Device | Class 3 | | |
| QFI | Synthetic Next-Generation Sequencing Quality Control And Filler Materi | Class N | | |
| QFK | Tumor Gene Profiling Test | Class N | | |
| QFV | Implantable Pulse Generator | Class 3 | | |
| QGP | Posterior Ratcheting Rod System | Class N | | |
| QGZ | Electrical Tumor Treatment Fields | Class 3 | | |
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use | Class 3 | | |
| QHP | Vertebral Body Tethering System | Class N | | |
| QHV | Multiple Osteoarticular Pathogen Antigen Kit | Class N | | |
| QIK | Organ Care System (Ocs) Heart System | Class 3 | | |
| QIM | Bartonella Spp. Serological Reagents | Class N | | |
| QIN | Babesia Spp. Serological Reagents | Class N | | |
| QIO | Anaplasma Spp. And Ehrlichia Spp. Serological Reagents | Class N | | |
| QIP | Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reag | Class N | | |
| QIQ | Orientia Spp. (Scrub Typhus) Serological Reagents | Class N | | |
| QIT | Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | Class 3 | | |
| QIX | System, Transdermal Delivery, Cder Or Cber Led | Class N | | |
| QIY | Nasal Spray, Systemic Delivery, Cder Or Cber Led | Class N | | |
| QIZ | Material, Implantable For Controlled Release, Cder Or Cber Led | Class N | | |
| QJA | Tympanostomy Tube Delivery Product With Drug | Class 3 | | |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Class N | | |
| QJX | Caries Detection Product With Drug Or Biologic | Class 3 | | |
| QKJ | Stent, Central Venous | Class 3 | | |
| QKO | Reagent, Coronavirus Serological | Class N | | |
| QKP | Coronavirus Antigen Detection Test System. | Class N | | |
| QKR | Face Mask Within The Scope Of The Face Mask And Barrier Face Covering | Class N | | |
| QKS | Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led | Class N | | |
| QKU | Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) | Class N | | |
| QKY | Decontamination Systems For N95 Respirators | Class N | | |
| QLC | Interleukin 6 | Class N | | |
| QLD | Protective Barrier Enclosure | Class N | | |
| QLE | Protective Barrier Enclosure With Negative Pressure | Class N | | |
| QLH | System, Intravaginal, For Controlled Release Of Drug Substance, Cder O | Class N | | |
| QLI | Vaporizer, Cder Or Cber Led | Class N | | |
| QLJ | Patient Monitor With Independent Remote Display And Operation | Class N | | |
| QLK | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For P | Class 3 | | |
| QLL | Left Ventricular Ejection Fraction Screening Tool | Class N | | |
| QLM | Intensive Care Unit, Respiratory Failure And Hemodynamic Instability T | Class N | | |
| QLN | Extracorporeal System For Carbon Dioxide Removal For The Treatment Of | Class N | | |
| QLO | Immunoadsorption Column For Emergency Use | Class N | | |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | Class N | | |
| QLW | Covid-19 Test Home Collection Kit Devices | Class N | | |
| QMF | Mask, Surgical, Eua Authorized | Class N | | |
| QMG | Shockwave Intravascular Lithotripsy System | Class 3 | | |
| QMN | Covid-19 Multi-Analyte Antigen Device | Class N | | |
| QNB | Plasma Processing System For Converting Alpha To Pre-Beta High-Density | Class F | | |
| QNK | Optoacoustic Imaging System | Class 3 | | |
| QNN | Prosthesis, Total Talus Replacement, Metal | Class F | | |
| QNY | Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolo | Class N | | |
| QNZ | Powered Communication System For Emergency Use | Class N | | |
| QOA | Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screen | Class N | | |
| QOC | Temporary Non-Roller Type Left Or Right Heart Support Blood Pump | Class N | | |
| QOD | Extracorporeal Circuit And Accessories For Long Term Respiratory Cario | Class N | | |
| QOJ | Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only) | Class N | | |
| QOO | Ventilator Tubing And Accessories | Class N | | |
| QOP | Respiratory Humidifier For Emergency Use | Class N | | |
| QOQ | Non-Continuous Ventilator For Emergency Use | Class N | | |
| QOR | Continuous Ventilator, Minimal Ventilatory Support | Class N | | |