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 |
|---|---|---|
| Pro Guard Nitrile Powder Free Examination Glove | 2022-08-06 | |
| Reprocesses Umbilical Cable | 2022-08-06 | |
| Avéli | 2022-08-05 | |
| FAMA Male Latex Condoms | 2022-08-05 | |
| MONOFIX PGCL, Knotless Wound Closure Device | 2022-08-05 | |
| Neurophet SCALE PET | 2022-08-05 | |
| Non-Sterile Powder Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | 2022-08-05 | |
| Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | 2022-08-05 | |
| Spineology Navigation Instruments | 2022-08-05 | |
| TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | 2022-08-05 | |
| Unispace SA Cervical Cage | 2022-08-05 | |
| Actera™ Hip System | 2022-08-04 | |
| Bloomi Smooth Water Based Lubricant | 2022-08-04 | |
| CenterMed Patient Matched Assisted Surgical Planning (ASP) System | 2022-08-04 | |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | 2022-08-04 | |
| Endoscope Model EG-580UT And Endoscope Model EG-580UR | 2022-08-04 | |
| ExGraft, ExGraft Carbon | 2022-08-04 | |
| MANTIS Clip | 2022-08-04 | |
| Masimo CARESCAPE SpO2 – Masimo With SpHb | 2022-08-04 | |
| MDHearingAid App, MDHearingAid Smart Hearing Aids | 2022-08-04 | |
| Mini-ClotTriever Thrombectomy System | 2022-08-04 | |
| Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | 2022-08-04 | |
| Cannulated Screws | 2022-08-03 | |
| Customize | 2022-08-03 | |
| ImmunoCAP Allergen F433, Allergen Component RTri A 14 LTP, Wheat, ImmunoCAP Allergen F416, Allergen Component RTri A 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen F449, Allergen Component RSes I 1 Sesame Seed | 2022-08-03 | |
| QScreen | 2022-08-03 | |
| Root ZX3 | 2022-08-03 | |
| Solidence Multipockets | 2022-08-03 | |
| Transpara 1.7.2 | 2022-08-03 | |
| Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid | 2022-07-30 | |
| 091 Balloon Guide Catheter | 2022-07-29 | |
| ABMD Software | 2022-07-29 | |
| Auxilock Titanium Screw-In Suture Anchor | 2022-07-29 | |
| Bodyport Cardiac Scale | 2022-07-29 | |
| Catapult Guide Sheath | 2022-07-29 | |
| Deep Learning Image Reconstruction | 2022-07-29 | |
| Dental Handpiece, Model CA160, CA160L, And CA500L | 2022-07-29 | |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System | 2022-07-29 | |
| DiviTum TKa | 2022-07-29 | |
| EleGARD | 2022-07-29 | |
| Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | 2022-07-29 | |
| Injection Needle | 2022-07-29 | |
| Medispine - Spinal Needle, Glospine - Spinal Needle | 2022-07-29 | |
| Microstream CO2 NanoPod | 2022-07-29 | |
| Next Generation NetKonnect | 2022-07-29 | |
| NobelProcera Zirconia N1 Base | 2022-07-29 | |
| OptiVu ROSA MxR | 2022-07-29 | |
| RhinAer® Stylus (FG1393) | 2022-07-29 | |
| S-Core Implant System | 2022-07-29 | |
| Tablo Hemodialysis System | 2022-07-29 | |
| Vascette HP (hemostatic Pad) | 2022-07-29 | |
| Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2022-07-29 | |
| BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | 2022-07-28 | |
| Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm X 160 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 Mm X 320 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 230 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 320 Cm, Beamer AVEO FIL | 2022-07-28 | |
| Biotres | 2022-07-28 | |
| Cvi42 Auto Imaging Software Application | 2022-07-28 | |
| EXALT Model B Single-Use Bronchoscope | 2022-07-28 | |
| Gastrointestinal Boundary Identifier (GIBI HD) | 2022-07-28 | |
| INERTIA CONNEXX Modular Pedicle Screw System | 2022-07-28 | |
| MagXtract Collection Tube | 2022-07-28 | |
| NeXus Ultrasonic Surgical Aspirator System | 2022-07-28 | |
| OsteoCentric Spine MIS Pedicle Fastener System | 2022-07-28 | |
| Single Use Cytology Brush | 2022-07-28 | |
| Swoop Portable MR Imaging System | 2022-07-28 | |
| Trinias | 2022-07-28 | |
| TRON | 2022-07-28 | |
| AOK 95A Medical Mask (20200049) | 2022-07-27 | |
| AquaA | 2022-07-27 | |
| BIOMONITOR IIIm, BIOMONITOR III | 2022-07-27 | |
| Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | 2022-07-27 | |
| CorPath GRX System | 2022-07-27 | |
| DeepRhythmAI | 2022-07-27 | |
| Disposable Nitrile Powder-Free Examination Gloves (Tested For Use With Chemotherapy Drugs) | 2022-07-27 | |
| Dornier Thulio | 2022-07-27 | |
| EliA Ro52, EliA Ro60 | 2022-07-27 | |
| HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | 2022-07-27 | |
| Hummingbird Tympanostomy Tube System | 2022-07-27 | |
| KeriFlex® MCP And PIP Finger Joint Prostheses | 2022-07-27 | |
| OTC DDR | 2022-07-27 | |
| Pegasus-X Expandable PLIF System | 2022-07-27 | |
| Powder Free Nitrile Examination Gloves (Blue),Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | 2022-07-27 | |
| Real Intelligence Cori | 2022-07-27 | |
| ReVive Light Therapy LED Cleansing System | 2022-07-27 | |
| TransLoc 3D | 2022-07-27 | |
| Upper Arm Type Blood Pressure Monitor | 2022-07-27 | |
| Powder-Free Nitrile Examination Glove, Non-Sterile | 2022-07-23 | |
| 10HQ701G-B | 2022-07-22 | |
| 14HQ701G-B | 2022-07-22 | |
| AI4CMR V1.0 | 2022-07-22 | |
| Align Lumbar Interbody Fusion System | 2022-07-22 | |
| BioFire JI Control Panel M420 | 2022-07-22 | |
| BLUE 400 | 2022-07-22 | |
| C-Stem AMT LE Prosthesis | 2022-07-22 | |
| Disposable Medical Face Mask (ear Loop) | 2022-07-22 | |
| DM Converter - TiN Coated | 2022-07-22 | |
| DuraFuse Clip And Applier System | 2022-07-22 | |
| EchoPAC Software Only, EchoPAC Plug-in | 2022-07-22 | |
| FX SPS | 2022-07-22 | |
| Kentrospine PSS Pedicle Screw System | 2022-07-22 | |
| MedWand | 2022-07-22 | |
| PreXion3D Explorer PRO | 2022-07-22 | |
| SECURE-LOCK | 2022-07-22 | |
| Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown | 2022-07-22 | |
| Synergy Marble (Model: Opasm) | 2022-07-22 | |
| TargetCool | 2022-07-22 | |
| Vivid E80, Vivid E90, Vivid E95 | 2022-07-22 | |
| BTI Interna Narrow/Plus Dental Implant System UnicCa | 2022-07-21 | |
| Celerity Incubator | 2022-07-21 | |
| Cionic Neural Sleeve NS-100 | 2022-07-21 | |
| Insufflation Retention Device | 2022-07-21 | |
| Life Scope PT BSM-1700 Series Bedside Monitor | 2022-07-21 | |
| Manual Wheelchair | 2022-07-21 | |
| Pump Alignment Syringe | 2022-07-21 | |
| Sterile Safety Syringes For Single Use (Retractable) | 2022-07-21 | |
| Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle | 2022-07-21 | |
| Wei Nasal Jet Tube | 2022-07-21 | |
| AF Laser | 2022-07-20 | |
| AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | 2022-07-20 | |
| AutoSeg | 2022-07-20 | |
| Biofeedback Nerve And Muscle Stimulator | 2022-07-20 | |
| Libby Echo:Prio | 2022-07-20 | |
| Pediatric Nailing Platform Femur | 2022-07-20 | |
| Pentaflush | 2022-07-20 | |
| Root Apex Locator | 2022-07-20 | |
| TruDi Shaver Blade | 2022-07-20 | |
| Vario-Cup System | 2022-07-20 | |
| Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | 2022-07-20 | |
| 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | 2022-07-16 | |
| Powder Free Nitrile Examination Gloves, (Cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves | 2022-07-16 | |
| Alinity M EBV AMP Kit (List No. 09N43-095), Alinity M EBV CTRL Kit (List No. 09N43-085), Alinity M EBV CAL Kit (List No. 09N43-075) | 2022-07-15 | |
| ComPAS2 | 2022-07-15 | |
| CUSA Clarity Ultrasonic Surgical Aspirator System | 2022-07-15 | |
| Digital Radiography CXDI-Pro, Digital Radiography D1 | 2022-07-15 | |
| Ers2 - Ergoline Rehabilitation System | 2022-07-15 | |
| Facet 28G Universal Lancet | 2022-07-15 | |
| Hailie Sensor NF0106 | 2022-07-15 | |
| Kontact Dental Implant System | 2022-07-15 | |
| Model 9100 PFT/DICO | 2022-07-15 | |
| Nerve Tape | 2022-07-15 | |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy For Mental Health | 2022-07-15 | |
| NomadAir PMU810 | 2022-07-15 | |
| NxtGen Infant Transport Incubator | 2022-07-15 | |
| OK Handpiece | 2022-07-15 | |
| Renuvion APR Handpiece | 2022-07-15 | |
| Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | 2022-07-15 | |
| Tatum Surgical Dental Implant System | 2022-07-15 | |
| Vivid S60N, Vivid S70N | 2022-07-15 | |
| Set, Transfer (Blood/Plasma) | 2022-07-15 | |
| 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) | 2022-07-14 | |
| AGNES | 2022-07-14 | |
| AHI System | 2022-07-14 | |
| Alma Diode Tabletop Laser | 2022-07-14 | |
| Anatase Spine Surgery Navigation System, Model Number: SNS-Spine2-S And SNS-spine2-V | 2022-07-14 | |
| CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems | 2022-07-14 | |
| Dermatac Drape | 2022-07-14 | |
| Disposabel Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle | 2022-07-14 | |
| E-GPS Navigated Instruments | 2022-07-14 | |
| Examination Gloves-Type A(Latex Gloves) | 2022-07-14 | |
| KDF Zirconia Disc | 2022-07-14 | |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set | 2022-07-14 | |
| Normatec Go | 2022-07-14 | |
| PELNAC Meshed Bilayer Wound Matrix | 2022-07-14 | |
| SmileSeries | 2022-07-14 | |
| TROJAN(TM) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant | 2022-07-14 | |
| TruAbutment DS, TruBase | 2022-07-14 | |
| 17HQ701G-B | 2022-07-13 | |
| SNUCONE Bone Level Implant System | 2022-07-13 | |
| Syngo.CT Extended Functionality | 2022-07-13 | |
| TruSculpt ID | 2022-07-13 |