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
Geko™ W-22020-01-18
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire2020-01-18
Acqguide Flex With Acqcross Qx, Acqguide Mini With Acqcross Qx2020-01-17
Altera Gas Sampling Lines2020-01-17
AMD Ritmed AssureWear VersaGown2020-01-17
Asimov-MKS Imaging System2020-01-17
Bio-TackS Orthodontic Mini Implant2020-01-17
Black Diamond Navigation Instruments2020-01-17
C0152020-01-17
Caresens S Fit Bt Blood Glucose Monitoring System2020-01-17
CoLink Plating System, Fracture And Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System2020-01-17
CustomizedBone Service2020-01-17
Dental Pain Eraser2020-01-17
Evis Exera III Duodenovideoscope Olympus TJF-Q190V2020-01-17
LiNA OperaScope With HDMI Cable And On-board LCD - 6 Units, LiNA OperaScope Recording Module2020-01-17
MAGLUMI 2000 HCG/ß-HCG2020-01-17
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter2020-01-17
Merit ONE Snare System2020-01-17
PicoLazer Laser System2020-01-17
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)2020-01-17
RxSight Insertion Device2020-01-17
Sac2 - Electrode Cream2020-01-17
SoundBite Console, SoundBite Active Wire 182020-01-17
Study Watch With Irregular Pulse Monitor2020-01-17
Surelead Cable System2020-01-17
Actiflip Naked, Actiflip Cinch, Actiflip Whip, Gfs Ultimate Hip2020-01-16
ALLthread Titanium Suture Anchor2020-01-16
Auto Positioning2020-01-16
Electric Breast Pump2020-01-16
Glidescope Bflex 3.8 Single-use Bronchoscope2020-01-16
INNOVO2020-01-16
Maxxi Snore Sensor2020-01-16
Mobilit Cup2020-01-16
Resectr Tissue Resection Device2020-01-16
SherpaPak Lung Preservation System , SherpaPak Liver Transport System2020-01-16
Stellar M22 For Intense Pulsed Light (IPL) And Laser System2020-01-16
Viveve 2.0 System2020-01-16
ADAS 3D2020-01-15
Advia Centaur Total Ige (tige)2020-01-15
All’InCath 035M PTA Balloon Dilatation Catheter2020-01-15
Arthrex SwiveLock Suture Anchor2020-01-15
Clenchguard2020-01-15
Eko Analysis Software2020-01-15
INTRAcel RF Microneedle System2020-01-15
KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography2020-01-15
Livento Press, Soprano 10, Soprano2020-01-15
NEX-D2 Posterior Fixation System2020-01-15
UNO 302020-01-15
VitalScan ANS2020-01-15
Wattson Temporary Pacing Guidewire2020-01-15
Dental Pain Eraser2020-01-14
G210 Invicell Plus With Signiphy Ph Monitoring2020-01-14
Icare Ic2002020-01-14
MiiS Horus Eye Anterior Camera2020-01-14
Oragene®•Dx2020-01-14
SABLE Expandable Spacer2020-01-14
Streamline Tl Spinal Fixation System2020-01-14
XTRAC Momentum Excimer Laser System2020-01-14
Erchonia Emerald2020-01-13
Midwest Rhino XE And Air Motor M2020-01-13
Nva, Nvp, And Nvt2020-01-13
Route 92 Medical Sheath System2020-01-13
TENS And EMS Stimulator, TENS Stimulator2020-01-11
CD Horizon™ Fenestrated Screw Set2020-01-10
CorticaLINK Spinal Fusion Platform2020-01-10
Cybird LED Curing Light2020-01-10
FlowMet2020-01-10
IP Converter2020-01-10
KardioScreen2020-01-10
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs)2020-01-10
MotoBAND CP Implant System2020-01-10
Nihon Kohden NKV-550 Series Ventilator System2020-01-10
OsteoRemedies Hip Spacer System2020-01-10
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff2020-01-10
Univers Revers Modular Glenoid System (Augemented Baseplates)2020-01-10
Altapore2020-01-09
AMIStem-C2020-01-09
ER-REBOA PLUS Catheter2020-01-09
HyaloGYN Vaginal Moisturizing Suppositories2020-01-09
LED Curing Light2020-01-09
Longeviti ClearFit Cranial Implant2020-01-09
TrellOss™-L MPF2020-01-09
Tyber Medical Trauma Screws2020-01-09
Clear Aligner2020-01-08
EASYGRIP FLO-41 Precision MIS Delivery System2020-01-08
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device2020-01-08
Genesys Spine 3DP Cervical Interbody System2020-01-08
Sensititre 20-24 Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC Or Breakpoint, Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/mL2020-01-08
Tyber Medical Trauma Screw2020-01-08
Avenger Radial Head System2020-01-07
BioCardia 8F Morph DNA Deflectable Guide Catheter2020-01-07
CRF Radiofrequency Ablation System2020-01-07
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color2020-01-07
ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal Footswitch, Extension Cable F. ERBECRYO 2 Footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire Basket; Connecting Hoses, Switching Valves, Adapter2020-01-07
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch2020-01-07
EVOL Ha - D Lateral Interbody Fusion System2020-01-06
MRIaudio PREM System With MRIview2020-01-06
Multi-unit Abutments2020-01-06
Quadra-P2020-01-06
R2P Destination Slender Guiding Sheath2020-01-06
RS85 Diagnostic Ultrasound System2020-01-06
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece2020-01-06
TK Sterile Piston Syringe Without Needle2020-01-06
ViewPoint 62020-01-06
TriMed ASET Foot Plating System2020-01-05
AlignRT Plus2020-01-03
Conformity Stem, Cemented2020-01-03
Dillard Nasal Balloon Catheter2020-01-03
Endotics2020-01-03
Flex Body SPEEDER2020-01-03
MPowRx Snoring Solution (also Known As Good Morning Snore Solution)2020-01-03
NeuroBlate System2020-01-03
PALLAS 308/311 Solid-State UV Laser System2020-01-03
PiccGuard2020-01-03
Straumann Ceramic Healing Abutments2020-01-03
SureMAX Family Of Cervical Spacers2020-01-03
Z5-BL2020-01-03
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard2020-01-02
Air Next2020-01-02
ASAHI PTCA Guide Wire ASAHI Gaia Next2020-01-02
Elos Accurate Customized Abutment2020-01-02
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP2020-01-02
OC-Auto SENSOR Io IFOB Test2020-01-02
Optilume Basic Urological Balloon Dilation Catheter2020-01-02
OptoWire III2020-01-02
Sterile LeadConfirm2020-01-02
TunneLoc Tibial Fixation Device2020-01-02
Ureteral Stent Systems, Biliary Drainage Catheters2020-01-02
AutoMIStar2019-12-31
Digital Thermometer2019-12-31
InCore TMT System2019-12-31
MCare® Powder Free Nitrile Black Examination Glove2019-12-31
Patient Monitor2019-12-31
RadCalc Software2019-12-31
Depuy Synthes Maxillofacial Portfolio - MR Conditional2019-12-30
Disposable Valve Sets2019-12-30
Sterile Latex Surgical Glove, Powder Free2019-12-30
Straumann BLX Ø3.5 Mm Implants2019-12-27
True 3D Viewer Software2019-12-27
UroNav System2019-12-27
Volumetric Specimen Imager2019-12-27
Xcam2019-12-27
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft2019-12-27
InMode System With The Morpheus8 (Fractora) Applicators2019-12-27
Masimo Rad-97 And Accessories2019-12-27
Medical Radiation Dosimetry System MicroSTARii2019-12-27
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26
IHelmet Hair Growth System2019-12-26
Temporary Fixation Pins2019-12-26
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool2019-12-26
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