PMN requirements apply to Class III devices, the most stringent regulatory category for medical devices. The latest PMN approved devices are listed below. Search the PMN database here.
| Manufacturer | Device Name | Date |
|---|---|---|
| INVOS PM7100 Patient Monitor, INVOS Pediatric RSO2 Sensor, INVOS Infant Regional Saturation Sensor (also Referred To As OxyAlert NIRSensor) | 2021-12-05 | |
| Nitrile Powder Free Blue Examination Gloves, Non-Sterile | 2021-12-04 | |
| 21HQ513D | 2021-12-03 | |
| Adapter Sleeve For BIOLOX® OPTION Femoral Head, +10.5mm Head Length | 2021-12-03 | |
| AHI System | 2021-12-03 | |
| ArtiSential Trocar | 2021-12-03 | |
| Cydar EV (Series B) And Cydar EV Maps | 2021-12-03 | |
| Everyway Incontinence Stimulation System | 2021-12-03 | |
| ImplaStation | 2021-12-03 | |
| Independent Corneal Viewing Chamber (IVC-21) | 2021-12-03 | |
| Inspan ScrewLES Fusion System | 2021-12-03 | |
| Medline Cardiovascular Procedure Kit | 2021-12-03 | |
| Molecular Flow Simulations | 2021-12-03 | |
| PVmed Contouring Software | 2021-12-03 | |
| Solero Microwave Tissue Ablation (MTA) System And Accessories | 2021-12-03 | |
| Surgical Masks | 2021-12-03 | |
| Aimanfun Lumea Comfort, A-2789/A-3588 | 2021-12-02 | |
| AURORA Evacuator +Coag | 2021-12-02 | |
| Clivia Series Diagnostic Ultrasound System | 2021-12-02 | |
| Encevis | 2021-12-02 | |
| FUJIFILM Video Laparoscope EL-R740M30 | 2021-12-02 | |
| Nitrile Disposable Examination Gloves | 2021-12-02 | |
| OxyLight 2.0 | 2021-12-02 | |
| Powder Free Nitrile Examination Glove - White, Non-sterile | 2021-12-02 | |
| PS System | 2021-12-02 | |
| Puravita Medical Fold Flat Surgical Mask | 2021-12-02 | |
| Single-use Surgical Mask | 2021-12-02 | |
| AC Cream - Conductive Paste | 2021-12-01 | |
| DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T | 2021-12-01 | |
| Electric Breast Pump | 2021-12-01 | |
| Milli Vaginal Dilator | 2021-12-01 | |
| NGM WAVE PLIF Cage | 2021-12-01 | |
| Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | 2021-12-01 | |
| Powder Free Nitrile Examination Glove- Blue, Non-sterile | 2021-12-01 | |
| Sphincterotome / Short-wire Compatible, Sterile Sphincterotome | 2021-12-01 | |
| Vantage Fortian 1.5T, MRT-1550, V8.0 With AiCE Reconstruction Processing Unit For MR | 2021-12-01 | |
| ALTMS Magnetic Stimulation Therapy System | 2021-11-26 | |
| CUBE Air Purifier | 2021-11-26 | |
| MammoScreen 2.0 | 2021-11-26 | |
| Medical Surgical Mask | 2021-11-26 | |
| Nitrile Examination Gloves | 2021-11-26 | |
| Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | 2021-11-26 | |
| Synthetic Nitrile Examination Gloves | 2021-11-26 | |
| Tablo Cartridge | 2021-11-26 | |
| Trevo Trak 21 Microcatheter | 2021-11-26 | |
| AMRA Profiler | 2021-11-24 | |
| Atellica CH Enzymatic Creatinine_3 (ECre3) | 2021-11-24 | |
| Bronchoscope System | 2021-11-24 | |
| C-30 Crown Kit | 2021-11-24 | |
| ControlRad Select Model Z | 2021-11-24 | |
| Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | 2021-11-24 | |
| Guiding Catheter | 2021-11-24 | |
| MicroPen EVO | 2021-11-24 | |
| Non-Contact Infrared Thermometer, Model HL710H | 2021-11-24 | |
| Regulora | 2021-11-24 | |
| Surgical Mask (sterile) | 2021-11-24 | |
| The Radian MIS Bunion System | 2021-11-24 | |
| Trachealator | 2021-11-24 | |
| Xpert Wrist | 2021-11-24 | |
| Arthrex Vortex Threaded Bone Marrow Recovery Needle | 2021-11-19 | |
| BD Nano 2nd Gen Pen Needle | 2021-11-19 | |
| Catalyft LS Expandable Interbody System | 2021-11-19 | |
| Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | 2021-11-19 | |
| EkoSonic Endovascular Device | 2021-11-19 | |
| EndoScreener | 2021-11-19 | |
| Finebeam | 2021-11-19 | |
| Frontier Series Power Wheelchairs | 2021-11-19 | |
| HALYARD Flexaprene Green Powder-Free Exam Glove | 2021-11-19 | |
| Leaf Smooth | 2021-11-19 | |
| MR 5300 | 2021-11-19 | |
| OnQ Neuro | 2021-11-19 | |
| Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | 2021-11-19 | |
| Vector® Hammertoe Correction System | 2021-11-19 | |
| Velofix SA Cervical Cage | 2021-11-19 | |
| Capiox ICP Centrifugal Pump | 2021-11-18 | |
| Cardiologs Holter Platform | 2021-11-18 | |
| CoLink Vallux Plating System | 2021-11-18 | |
| Dermalux Flex MD | 2021-11-18 | |
| Desnuda Reflect | 2021-11-18 | |
| Disposable Medical Nitrile Examination Gloves (Non-sterile) | 2021-11-18 | |
| DIXI Medical Microdeep Micro-Macro Depth Electrodes | 2021-11-18 | |
| FAICO Dental Implant System And CAD/CAM Abutments | 2021-11-18 | |
| Gemini 2 810+980 Soft Tissue Laser | 2021-11-18 | |
| HANAROSTENT Esophagus Asymmetric (CCC) | 2021-11-18 | |
| Impertech Surgical Face Mask | 2021-11-18 | |
| IPL Hair Removal, Model: OBT-02 | 2021-11-18 | |
| LINK® Embrace Shoulder System - Reverse Configuration | 2021-11-18 | |
| MD-320W Ultrasound Biomicroscope | 2021-11-18 | |
| Medley | 2021-11-18 | |
| Reprocessed IntellaMap Orion High Resolution Mapping Catheter | 2021-11-18 | |
| Savvy Mask - Level 3 Surgical Face Mask | 2021-11-18 | |
| Stratum® Ankle Fusion Plating System | 2021-11-18 | |
| SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | 2021-11-18 | |
| VALORY | 2021-11-18 | |
| Water-soluble Personal Lubricant | 2021-11-18 | |
| Arthrex Modular Glenoid System-Titanium Glenosphere | 2021-11-17 | |
| BruxZir Esthetic | 2021-11-17 | |
| Disposable Surgical Mask | 2021-11-17 | |
| Lunit INSIGHT MMG | 2021-11-17 | |
| Promisemed Sharps Container | 2021-11-17 | |
| Protect X Level 3 Isolation Gown | 2021-11-17 | |
| Qora Stool Management Kit | 2021-11-17 | |
| Soteria.AI | 2021-11-17 | |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | 2021-11-17 | |
| Disposable Surgical Gowns | 2021-11-13 | |
| Surgical Face Mask | 2021-11-13 | |
| Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System | 2021-11-12 | |
| DR-HO's Back Pain Relief System Pro (Models BPRS-I And BPRS-II) | 2021-11-12 | |
| Erchonia FX-405 | 2021-11-12 | |
| ETEST Fosfomycin (FO) (0.032-512 µg/mL) | 2021-11-12 | |
| HYDRASHIFT 2/4 Isatuximab | 2021-11-12 | |
| Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | 2021-11-12 | |
| Intellijoint VIEW | 2021-11-12 | |
| MAMMOVISTA B.smart | 2021-11-12 | |
| MiPACS HTML5 Web Viewer | 2021-11-12 | |
| NightGuard Flex | 2021-11-12 | |
| Tornier Perform™ Patient-Matched Primary Reversed Glenoid And BLUEPRINT™ Patient Specific Instrumentation | 2021-11-12 | |
| Wrap Accessory Electrodes | 2021-11-12 | |
| Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2021-11-12 | |
| Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) | 2021-11-11 | |
| EnSite X EP System | 2021-11-11 | |
| Nitrile Examination Glove (Powder Free, Blue) | 2021-11-11 | |
| AlignRT Plus | 2021-11-10 | |
| Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | 2021-11-10 | |
| Diode Laser Therapy System | 2021-11-10 | |
| Disposable Automatic Core Biopsy Instrument | 2021-11-10 | |
| EKuore Pro 4T - REF EP0098 | 2021-11-10 | |
| ESSENZ Patient Monitor | 2021-11-10 | |
| Identity Imprint Cruciate Retaining (CR) Knee Replacement System And Identity Imprint Posterior Stabilized (PS) Knee Replacement System | 2021-11-10 | |
| InVisionOS | 2021-11-10 | |
| Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | 2021-11-10 | |
| LTV2 Series Ventilators | 2021-11-10 | |
| Lunit INSIGHT CXR Triage | 2021-11-10 | |
| More-Cell-System | 2021-11-10 | |
| Powder Free Nitrile Patient Examination Gloves, Blue Color | 2021-11-10 | |
| Reverso | 2021-11-10 | |
| RTapp | 2021-11-10 | |
| Venen-trainer (Model: FM150, SFM90) | 2021-11-10 | |
| VSP® Orthopedics System | 2021-11-10 |