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 |
|---|---|---|
| Intravascular Extension Set | 2021-06-18 | |
| Port Access System | 2021-06-18 | |
| IBed Wireless With IBed Mobile | 2021-06-18 | |
| Kontact Dental Implant System | 2021-06-18 | |
| Transcutaneous Electrical Nerve Stimulator | 2021-06-18 | |
| AScope 4 Broncho Regular Sampler Set 5.0/2.2, AScope 4 Broncho Large Sampler Set 5.8/2.8 | 2021-06-17 | |
| Fix2Lock (Biocomposite Medial, Biocomposite Lateral, Biocombi Self Punching) | 2021-06-17 | |
| Migraine Tens Digital Pain Reliever | 2021-06-17 | |
| Precise Position | 2021-06-17 | |
| Su2ura Approximation Device | 2021-06-17 | |
| Fist Assist Devices Model FA-1 | 2021-06-17 | |
| Infrared Thermometer | 2021-06-17 | |
| MIS Lance+ Conical Connection Dental Implant System | 2021-06-17 | |
| NaviNetics D1 Stereotactic System | 2021-06-17 | |
| Restor3d Utility Wedge | 2021-06-17 | |
| Sonata Transcervical Fibroid Ablation System 2.2 | 2021-06-17 | |
| AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) | 2021-06-16 | |
| Disposable Medical Surgical Face Mask | 2021-06-16 | |
| EnsoSleep | 2021-06-16 | |
| Qmenta Care Platform Family | 2021-06-16 | |
| Aptiva Celiac Disease IgA Reagent | 2021-06-16 | |
| Disposable Vinyl Examination Glove | 2021-06-16 | |
| IBOT Personal Mobility Device (iBOT PMD) | 2021-06-16 | |
| Silent Nite Sleep Appliance With The Glidewell Hinge | 2021-06-16 | |
| Sublime Radial Access 018 RX Dilatation Catheter | 2021-06-16 | |
| Peripheral Blood Processing Device For Wound Management | 2021-06-16 | |
| Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N | 2021-06-13 | |
| Axon Therapy | 2021-06-11 | |
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | 2021-06-11 | |
| EOS Air Cleaner | 2021-06-11 | |
| Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | 2021-06-11 | |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | 2021-06-11 | |
| Medical Face Mask | 2021-06-11 | |
| Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | 2021-06-11 | |
| PANAVIA Veneer LC | 2021-06-11 | |
| POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | 2021-06-11 | |
| Radius T Wearable Thermometer | 2021-06-11 | |
| Replens Long-Lasting Vaginal Moisturizer | 2021-06-11 | |
| Surgical Face Mask | 2021-06-11 | |
| BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) | 2021-06-10 | |
| Blood Administration Set | 2021-06-10 | |
| Callaly Tampliner | 2021-06-10 | |
| Disposable Surgical Mask | 2021-06-10 | |
| Disposable Vinyl Examination Gloves | 2021-06-10 | |
| Fiducial Marker | 2021-06-10 | |
| H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit For Two, JO 2 To Tango For Me, JO 2 To Tango Couples Pleasure Kit | 2021-06-10 | |
| H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango For You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit For Two | 2021-06-10 | |
| IDx-DR | 2021-06-10 | |
| M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | 2021-06-10 | |
| Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound | 2021-06-10 | |
| Spirometer | 2021-06-10 | |
| Surgical Face Mask | 2021-06-10 | |
| Surgical Masks, Model:FE-1 | 2021-06-10 | |
| Symmetric Total Knee System | 2021-06-10 | |
| Syngo.via MI WorkFlows, Scenium, Syngo MBF | 2021-06-10 | |
| ELEOS Limb Salvage System With BioGrip | 2021-06-09 | |
| Navigated Anterolateral Disc Prep Instruments | 2021-06-09 | |
| Palm Bladder Scanner - PBSV7.1 | 2021-06-09 | |
| Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | 2021-06-09 | |
| Vivid S60N / Vivid S70N | 2021-06-09 | |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) System | 2021-06-04 | |
| Avon Patello-femoral Joint Prosthesis | 2021-06-04 | |
| Dentis S-Clean S-Line Mini | 2021-06-04 | |
| Disposable Medical Mask | 2021-06-04 | |
| ECT Cotton Bite Block- Size Large, ECT Cotton Bite Block -size Medium | 2021-06-04 | |
| Fix2Lock (PEEK Self Punching) | 2021-06-04 | |
| GlidePath 13F Long-Term Hemodialysis Catheter | 2021-06-04 | |
| HIT Clear Aligner | 2021-06-04 | |
| Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) | 2021-06-04 | |
| Insulia Diabetes Management Companion | 2021-06-04 | |
| Kendall NPWT Incision Management Device | 2021-06-04 | |
| Micro C Medical Imaging System, M01 | 2021-06-04 | |
| Nitrile Patient Examination Gloves | 2021-06-04 | |
| Perfect EMS | 2021-06-04 | |
| Prudent 1717, Prudent 1417, Prudent 1212 | 2021-06-04 | |
| SureStrip Vitrification Straw, SureLock Vitrification Straw | 2021-06-04 | |
| Surgical Face Mask | 2021-06-04 | |
| Surgical Green Laser System | 2021-06-04 | |
| TruBase S | 2021-06-04 | |
| Allmed Surgical Face Masks (Ear Loops) | 2021-06-03 | |
| ASTRA Spine System | 2021-06-03 | |
| Breezeway II | 2021-06-03 | |
| Intellihab System | 2021-06-03 | |
| PCA-C1 Series Patient Cable | 2021-06-03 | |
| SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories) | 2021-06-03 | |
| 6MS Invisible Aligner | 2021-06-02 | |
| ASM-301 Level 3 Surgical Mask | 2021-06-02 | |
| BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System | 2021-06-02 | |
| DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | 2021-06-02 | |
| Disposable Medical Mask | 2021-06-02 | |
| Disposable Surgical Face Mask | 2021-06-02 | |
| Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS) | 2021-06-02 | |
| NATRELLE INSPIRA Single Use Sizers For Gel Implants | 2021-06-02 | |
| SeaSpine WaveForm™ A Interbody System | 2021-06-02 | |
| Surgical Face Mask | 2021-06-02 | |
| Transpara 1.7.0 | 2021-06-02 | |
| ABT12 Multi-purpose Solution | 2021-05-28 | |
| AtriCure Isolator® Synergy™ Surgical Ablation System | 2021-05-28 | |
| Axis Charcot Fixation System | 2021-05-28 | |
| CoraCross | 2021-05-28 | |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | 2021-05-28 | |
| Infant Phototherapy Equipment | 2021-05-28 | |
| INVU By Nuvo | 2021-05-28 | |
| Irrisept Antimicrobial Wound Lavage | 2021-05-28 | |
| LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, And Shell/Insert Adapters | 2021-05-28 | |
| LINQ II Insertable Cardiac Monitor | 2021-05-28 | |
| MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, And GALAXY G3 Mini Microcoil Delivery Systems | 2021-05-28 | |
| Pathfinder Endoscope Overtube | 2021-05-28 | |
| Single Use Injection Needle | 2021-05-28 | |
| Aqua Medical RF Vapor System | 2021-05-27 | |
| BIB Stent Placement Catheter | 2021-05-27 | |
| Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads | 2021-05-27 | |
| ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs | 2021-05-27 | |
| GalaSTITCH Absorbable Monofilament Suture | 2021-05-27 | |
| LigaPASS® Spinal System, CD Horizon™ Spinal System | 2021-05-27 | |
| ZedView | 2021-05-27 | |
| Counter, Differential Cell | 2021-05-27 | |
| Breast Volume Navigator (BVN) Model G-2000 | 2021-05-26 | |
| Disposable Synthetic Examination Gloves | 2021-05-26 | |
| Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody Sys | 2021-05-26 | |
| Fassier-Duval Telescopic IM System | 2021-05-26 | |
| Implacil Implant System | 2021-05-26 | |
| Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves | 2021-05-26 | |
| OTE MPS 045 Multi-purpose Lens Care Solution | 2021-05-26 | |
| Peak Flow Meter | 2021-05-26 | |
| PlasmaWave | 2021-05-26 | |
| SpyGlass Discover Retrieval Basket | 2021-05-26 | |
| ViperCath XC Peripheral Exchange Catheter | 2021-05-26 |