FDA 510(k) PMN

Database of Premarket Notifications


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.

Latest Premarket Notifications

ManufacturerDevice NameDate
Pro Guard Nitrile Powder Free Examination Glove2022-08-06
Reprocesses Umbilical Cable2022-08-06
Avéli2022-08-05
FAMA Male Latex Condoms2022-08-05
MONOFIX PGCL, Knotless Wound Closure Device2022-08-05
Neurophet SCALE PET2022-08-05
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 Instruments2022-08-05
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)2022-08-05
Unispace SA Cervical Cage2022-08-05
Actera™ Hip System2022-08-04
Bloomi Smooth Water Based Lubricant2022-08-04
CenterMed Patient Matched Assisted Surgical Planning (ASP) System2022-08-04
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay2022-08-04
Endoscope Model EG-580UT And Endoscope Model EG-580UR2022-08-04
ExGraft, ExGraft Carbon2022-08-04
MANTIS Clip2022-08-04
Masimo CARESCAPE SpO2 – Masimo With SpHb2022-08-04
MDHearingAid App, MDHearingAid Smart Hearing Aids2022-08-04
Mini-ClotTriever Thrombectomy System2022-08-04
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)2022-08-04
Cannulated Screws2022-08-03
Customize2022-08-03
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 Seed2022-08-03
QScreen2022-08-03
Root ZX32022-08-03
Solidence Multipockets2022-08-03
Transpara 1.7.22022-08-03
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid2022-07-30
091 Balloon Guide Catheter2022-07-29
ABMD Software2022-07-29
Auxilock Titanium Screw-In Suture Anchor2022-07-29
Bodyport Cardiac Scale2022-07-29
Catapult Guide Sheath2022-07-29
Deep Learning Image Reconstruction2022-07-29
Dental Handpiece, Model CA160, CA160L, And CA500L2022-07-29
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System2022-07-29
DiviTum TKa2022-07-29
EleGARD2022-07-29
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)2022-07-29
Injection Needle2022-07-29
Medispine - Spinal Needle, Glospine - Spinal Needle2022-07-29
Microstream CO2 NanoPod2022-07-29
Next Generation NetKonnect2022-07-29
NobelProcera Zirconia N1 Base2022-07-29
OptiVu ROSA MxR2022-07-29
RhinAer® Stylus (FG1393)2022-07-29
S-Core Implant System2022-07-29
Tablo Hemodialysis System2022-07-29
Vascette HP (hemostatic Pad)2022-07-29
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2022-07-29
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel2022-07-28
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 FIL2022-07-28
Biotres2022-07-28
Cvi42 Auto Imaging Software Application2022-07-28
EXALT Model B Single-Use Bronchoscope2022-07-28
Gastrointestinal Boundary Identifier (GIBI HD)2022-07-28
INERTIA CONNEXX Modular Pedicle Screw System2022-07-28
MagXtract Collection Tube2022-07-28
NeXus Ultrasonic Surgical Aspirator System2022-07-28
OsteoCentric Spine MIS Pedicle Fastener System2022-07-28
Single Use Cytology Brush2022-07-28
Swoop Portable MR Imaging System2022-07-28
Trinias2022-07-28
TRON2022-07-28
AOK 95A Medical Mask (20200049)2022-07-27
AquaA2022-07-27
BIOMONITOR IIIm, BIOMONITOR III2022-07-27
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit2022-07-27
CorPath GRX System2022-07-27
DeepRhythmAI2022-07-27
Disposable Nitrile Powder-Free Examination Gloves (Tested For Use With Chemotherapy Drugs)2022-07-27
Dornier Thulio2022-07-27
EliA Ro52, EliA Ro602022-07-27
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap2022-07-27
Hummingbird Tympanostomy Tube System2022-07-27
KeriFlex® MCP And PIP Finger Joint Prostheses2022-07-27
OTC DDR2022-07-27
Pegasus-X Expandable PLIF System2022-07-27
Powder Free Nitrile Examination Gloves (Blue),Tested For Use With Chemotherapy Drugs And Fentanyl Citrate2022-07-27
Real Intelligence Cori2022-07-27
ReVive Light Therapy LED Cleansing System2022-07-27
TransLoc 3D2022-07-27
Upper Arm Type Blood Pressure Monitor2022-07-27
Powder-Free Nitrile Examination Glove, Non-Sterile2022-07-23
10HQ701G-B2022-07-22
14HQ701G-B2022-07-22
AI4CMR V1.02022-07-22
Align Lumbar Interbody Fusion System2022-07-22
BioFire JI Control Panel M4202022-07-22
BLUE 4002022-07-22
C-Stem AMT LE Prosthesis2022-07-22
Disposable Medical Face Mask (ear Loop)2022-07-22
DM Converter - TiN Coated2022-07-22
DuraFuse Clip And Applier System2022-07-22
EchoPAC Software Only, EchoPAC Plug-in2022-07-22
FX SPS2022-07-22
Kentrospine PSS Pedicle Screw System2022-07-22
MedWand2022-07-22
PreXion3D Explorer PRO2022-07-22
SECURE-LOCK2022-07-22
Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown2022-07-22
Synergy Marble (Model: Opasm)2022-07-22
TargetCool2022-07-22
Vivid E80, Vivid E90, Vivid E952022-07-22
BTI Interna Narrow/Plus Dental Implant System UnicCa2022-07-21
Celerity Incubator2022-07-21
Cionic Neural Sleeve NS-1002022-07-21
Insufflation Retention Device2022-07-21
Life Scope PT BSM-1700 Series Bedside Monitor2022-07-21
Manual Wheelchair2022-07-21
Pump Alignment Syringe2022-07-21
Sterile Safety Syringes For Single Use (Retractable)2022-07-21
Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle2022-07-21
Wei Nasal Jet Tube2022-07-21
AF Laser2022-07-20
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle2022-07-20
AutoSeg2022-07-20
Biofeedback Nerve And Muscle Stimulator2022-07-20
Libby Echo:Prio2022-07-20
Pediatric Nailing Platform Femur2022-07-20
Pentaflush2022-07-20
Root Apex Locator2022-07-20
TruDi Shaver Blade2022-07-20
Vario-Cup System2022-07-20
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)2022-07-20
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub2022-07-16
Powder Free Nitrile Examination Gloves, (Cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves2022-07-16
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
ComPAS22022-07-15
CUSA Clarity Ultrasonic Surgical Aspirator System2022-07-15
Digital Radiography CXDI-Pro, Digital Radiography D12022-07-15
Ers2 - Ergoline Rehabilitation System2022-07-15
Facet 28G Universal Lancet2022-07-15
Hailie Sensor NF01062022-07-15
Kontact Dental Implant System2022-07-15
Model 9100 PFT/DICO2022-07-15
Nerve Tape2022-07-15
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy For Mental Health2022-07-15
NomadAir PMU8102022-07-15
NxtGen Infant Transport Incubator2022-07-15
OK Handpiece2022-07-15
Renuvion APR Handpiece2022-07-15
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems2022-07-15
Tatum Surgical Dental Implant System2022-07-15
Vivid S60N, Vivid S70N2022-07-15
Set, Transfer (Blood/Plasma)2022-07-15
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)2022-07-14
AGNES2022-07-14
AHI System2022-07-14
Alma Diode Tabletop Laser2022-07-14
Anatase Spine Surgery Navigation System, Model Number: SNS-Spine2-S And SNS-spine2-V2022-07-14
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems2022-07-14
Dermatac Drape2022-07-14
Disposabel Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle2022-07-14
E-GPS Navigated Instruments2022-07-14
Examination Gloves-Type A(Latex Gloves)2022-07-14
KDF Zirconia Disc2022-07-14
LIAISON MeMed BV, LIAISON MeMed BV Control Set2022-07-14
Normatec Go2022-07-14
PELNAC Meshed Bilayer Wound Matrix2022-07-14
SmileSeries2022-07-14
TROJAN(TM) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant2022-07-14
TruAbutment DS, TruBase2022-07-14
17HQ701G-B2022-07-13
SNUCONE Bone Level Implant System2022-07-13
Syngo.CT Extended Functionality2022-07-13
TruSculpt ID2022-07-13

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