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 |