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
Intravascular Extension Set2021-06-18
Port Access System2021-06-18
IBed Wireless With IBed Mobile2021-06-18
Kontact Dental Implant System2021-06-18
Transcutaneous Electrical Nerve Stimulator2021-06-18
AScope 4 Broncho Regular Sampler Set 5.0/2.2, AScope 4 Broncho Large Sampler Set 5.8/2.82021-06-17
Fix2Lock (Biocomposite Medial, Biocomposite Lateral, Biocombi Self Punching)2021-06-17
Migraine Tens Digital Pain Reliever2021-06-17
Precise Position2021-06-17
Su2ura Approximation Device2021-06-17
Fist Assist Devices Model FA-12021-06-17
Infrared Thermometer2021-06-17
MIS Lance+ Conical Connection Dental Implant System2021-06-17
NaviNetics D1 Stereotactic System2021-06-17
Restor3d Utility Wedge2021-06-17
Sonata Transcervical Fibroid Ablation System 2.22021-06-17
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)2021-06-16
Disposable Medical Surgical Face Mask2021-06-16
EnsoSleep2021-06-16
Qmenta Care Platform Family2021-06-16
Aptiva Celiac Disease IgA Reagent2021-06-16
Disposable Vinyl Examination Glove2021-06-16
IBOT Personal Mobility Device (iBOT PMD)2021-06-16
Silent Nite Sleep Appliance With The Glidewell Hinge2021-06-16
Sublime Radial Access 018 RX Dilatation Catheter2021-06-16
Peripheral Blood Processing Device For Wound Management2021-06-16
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 N2021-06-13
Axon Therapy2021-06-11
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD2021-06-11
EOS Air Cleaner2021-06-11
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants2021-06-11
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System2021-06-11
Medical Face Mask2021-06-11
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H2021-06-11
PANAVIA Veneer LC2021-06-11
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS2021-06-11
Radius T Wearable Thermometer2021-06-11
Replens Long-Lasting Vaginal Moisturizer2021-06-11
Surgical Face Mask2021-06-11
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 Set2021-06-10
Callaly Tampliner2021-06-10
Disposable Surgical Mask2021-06-10
Disposable Vinyl Examination Gloves2021-06-10
Fiducial Marker2021-06-10
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 Kit2021-06-10
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 Two2021-06-10
IDx-DR2021-06-10
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System2021-06-10
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 Ultrasound2021-06-10
Spirometer2021-06-10
Surgical Face Mask2021-06-10
Surgical Masks, Model:FE-12021-06-10
Symmetric Total Knee System2021-06-10
Syngo.via MI WorkFlows, Scenium, Syngo MBF2021-06-10
ELEOS Limb Salvage System With BioGrip2021-06-09
Navigated Anterolateral Disc Prep Instruments2021-06-09
Palm Bladder Scanner - PBSV7.12021-06-09
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-0002021-06-09
Vivid S60N / Vivid S70N2021-06-09
AlphaVac Multipurpose Mechanical Aspiration (MMA) System2021-06-04
Avon Patello-femoral Joint Prosthesis2021-06-04
Dentis S-Clean S-Line Mini2021-06-04
Disposable Medical Mask2021-06-04
ECT Cotton Bite Block- Size Large, ECT Cotton Bite Block -size Medium2021-06-04
Fix2Lock (PEEK Self Punching)2021-06-04
GlidePath 13F Long-Term Hemodialysis Catheter2021-06-04
HIT Clear Aligner2021-06-04
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)2021-06-04
Insulia Diabetes Management Companion2021-06-04
Kendall NPWT Incision Management Device2021-06-04
Micro C Medical Imaging System, M012021-06-04
Nitrile Patient Examination Gloves2021-06-04
Perfect EMS2021-06-04
Prudent 1717, Prudent 1417, Prudent 12122021-06-04
SureStrip Vitrification Straw, SureLock Vitrification Straw2021-06-04
Surgical Face Mask2021-06-04
Surgical Green Laser System2021-06-04
TruBase S2021-06-04
Allmed Surgical Face Masks (Ear Loops)2021-06-03
ASTRA Spine System2021-06-03
Breezeway II2021-06-03
Intellihab System2021-06-03
PCA-C1 Series Patient Cable2021-06-03
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories)2021-06-03
6MS Invisible Aligner2021-06-02
ASM-301 Level 3 Surgical Mask2021-06-02
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System2021-06-02
DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System)2021-06-02
Disposable Medical Mask2021-06-02
Disposable Surgical Face Mask2021-06-02
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS)2021-06-02
NATRELLE INSPIRA Single Use Sizers For Gel Implants2021-06-02
SeaSpine WaveForm™ A Interbody System2021-06-02
Surgical Face Mask2021-06-02
Transpara 1.7.02021-06-02
ABT12 Multi-purpose Solution2021-05-28
AtriCure Isolator® Synergy™ Surgical Ablation System2021-05-28
Axis Charcot Fixation System2021-05-28
CoraCross2021-05-28
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index2021-05-28
Infant Phototherapy Equipment2021-05-28
INVU By Nuvo2021-05-28
Irrisept Antimicrobial Wound Lavage2021-05-28
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, And Shell/Insert Adapters2021-05-28
LINQ II Insertable Cardiac Monitor2021-05-28
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, And GALAXY G3 Mini Microcoil Delivery Systems2021-05-28
Pathfinder Endoscope Overtube2021-05-28
Single Use Injection Needle2021-05-28
Aqua Medical RF Vapor System2021-05-27
BIB Stent Placement Catheter2021-05-27
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads2021-05-27
ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs2021-05-27
GalaSTITCH Absorbable Monofilament Suture2021-05-27
LigaPASS® Spinal System, CD Horizon™ Spinal System2021-05-27
ZedView2021-05-27
Counter, Differential Cell2021-05-27
Breast Volume Navigator (BVN) Model G-20002021-05-26
Disposable Synthetic Examination Gloves2021-05-26
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 Sys2021-05-26
Fassier-Duval Telescopic IM System2021-05-26
Implacil Implant System2021-05-26
Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves2021-05-26
OTE MPS 045 Multi-purpose Lens Care Solution2021-05-26
Peak Flow Meter2021-05-26
PlasmaWave2021-05-26
SpyGlass Discover Retrieval Basket2021-05-26
ViperCath XC Peripheral Exchange Catheter2021-05-26

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