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 |
|---|---|---|
| Cadwell Bolt Software | 2019-11-23 | |
| DEXIS CariVu 3-in-1 By KaVo | 2019-11-23 | |
| 3M™ Attest™ Steam Chemical Integrators | 2019-11-22 | |
| 6450 Ultrasound System | 2019-11-22 | |
| ADVIA Centaur CA 15-3 Assay | 2019-11-22 | |
| AMIStem-P Short Neck | 2019-11-22 | |
| Applied Medical Laparoscopic Linear Cutter | 2019-11-22 | |
| BruxZir GT (Gum Tissue) Color | 2019-11-22 | |
| C2 CryoBalloon EndoGrip | 2019-11-22 | |
| Color Liquid, Vita Liquid | 2019-11-22 | |
| EverX Flow | 2019-11-22 | |
| EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | 2019-11-22 | |
| EXPD 4343P, EXPD 3643P | 2019-11-22 | |
| Hair Growth System | 2019-11-22 | |
| Healy | 2019-11-22 | |
| Hemochron Signature Elite | 2019-11-22 | |
| INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | 2019-11-22 | |
| KLS Martin Individual Patient Solutions | 2019-11-22 | |
| LEva Pelvic Digital Health System | 2019-11-22 | |
| MatriStem UBM Pericardial Patch | 2019-11-22 | |
| Medsynapse Ris Pacs & Medsynapse VNA | 2019-11-22 | |
| Navigated Anterolateral Disc Prep Instruments | 2019-11-22 | |
| Navina Smart System, Navina Classic System | 2019-11-22 | |
| Parcus Synd-EZ SS | 2019-11-22 | |
| Parkell Desensitizer Gel | 2019-11-22 | |
| PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | 2019-11-22 | |
| Revitalair 430F | 2019-11-22 | |
| Senhance Surgical System | 2019-11-22 | |
| SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | 2019-11-22 | |
| SMR TT Augmented Glenoid System | 2019-11-22 | |
| Spes Medica Subdermal Needle Electrodes | 2019-11-22 | |
| Synergy Platform, Synergy, Infinity, VersaHD | 2019-11-22 | |
| Trevo NXT ProVue Retriever | 2019-11-22 | |
| Trevo Trak 21 Microcatheter | 2019-11-22 | |
| VariAx Foot | 2019-11-22 | |
| Asahi PTCA Guide Wire Asahi SION Series | 2019-11-21 | |
| Axis Plating System | 2019-11-21 | |
| Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories | 2019-11-21 | |
| CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | 2019-11-21 | |
| Engage™ Partial Knee System | 2019-11-21 | |
| LZI Cotinine II Enzyme Immunoassay | 2019-11-21 | |
| M. Blue Adjustable Shunt System | 2019-11-21 | |
| PG Pro Microcatheter | 2019-11-21 | |
| SAM IO Intraosseous Access System | 2019-11-21 | |
| Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | 2019-11-21 | |
| SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO | 2019-11-21 | |
| Torpedo Gelatin Foam | 2019-11-21 | |
| UPMR 790 | 2019-11-20 | |
| Ziehm 8000 | 2019-11-20 | |
| AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior | 2019-11-20 | |
| FUJIFILM Endoscope Model EC-760Z-V/L | 2019-11-20 | |
| Penumbra LP Coil System | 2019-11-20 | |
| SDS1.2 Dental Implant | 2019-11-20 | |
| SmartLite Pro Modular LED Curing Light | 2019-11-20 | |
| TranS1 AxiaLIF Plus System | 2019-11-20 | |
| 3M Comply Hydrogen Peroxide Chemical Indicator | 2019-11-16 | |
| Dornier Ureteral Stent | 2019-11-15 | |
| HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | 2019-11-15 | |
| Pentax Medical Video Duodenoscope ED34-i10T2 | 2019-11-15 | |
| EM SA Implant System | 2019-11-15 | |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | 2019-11-15 | |
| DRSplus | 2019-11-15 | |
| Arcus Head Fixation Frame | 2019-11-15 | |
| CoolTone | 2019-11-15 | |
| KeyPrint KeySplint Soft | 2019-11-15 | |
| Ophthalmic Yag Laser System YC-200 | 2019-11-15 | |
| ROSA Bracket | 2019-11-15 | |
| Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | 2019-11-15 | |
| Gabriel Feeding Tube With Balloon, And EnFit Connector | 2019-11-15 | |
| SmartSPACE Shoulder System | 2019-11-15 | |
| CAPERE Thrombectomy System | 2019-11-15 | |
| Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | 2019-11-15 | |
| Soltus 500 | 2019-11-15 | |
| SPY Portable Handheld Imaging (SPY-PHI) System | 2019-11-15 | |
| TDM Plate And Screw Systems | 2019-11-15 | |
| Brainlab Compatible K2M Navigation Instruments | 2019-11-14 | |
| LongBow Ti | 2019-11-14 | |
| E-100 Electrosurgical Generator, SynchroSeal | 2019-11-14 | |
| HeraBEAT™ US | 2019-11-14 | |
| MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL) | 2019-11-14 | |
| ST Internal Implant System | 2019-11-14 | |
| EBA One Nailing System | 2019-11-14 | |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | 2019-11-14 | |
| Allwin Intra Uterine Insemination Catheters (INSEMINA And INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED And CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE And TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLE | 2019-11-14 | |
| Reprocessed ViewFlex™ Xtra ICE Catheter | 2019-11-14 | |
| AMICUS Separator System | 2019-11-13 | |
| AEON-C Stand Alone System | 2019-11-13 | |
| Infrared Thermometer Model MD-H30 | 2019-11-13 | |
| EchoGo Core | 2019-11-13 | |
| Piper GO-IO Intraosseous Infusion System | 2019-11-13 | |
| Nox Sleep System | 2019-11-13 | |
| GMA 2.0 Pedicle Screw System | 2019-11-13 | |
| NuVasive CoRoent Small Interlock System | 2019-11-13 |