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
BEAR And BEAR Mini2020-07-31
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords2020-07-31
Carto Octaray Mapping Catheter With Trueref Technology2020-07-31
Cemented Origin Hip Stem2020-07-31
Clear Guide SCENERGY2020-07-31
CORBEL Spacers2020-07-31
Cyber Blade2020-07-31
Flex Fit2020-07-31
I Do2020-07-31
Kendall NPWT Incision Management Dressing Kit2020-07-31
Lin-zhi International, Inc. (lzi) Methamphetamine Enzyme Immunoassay For Pictus Analyzers2020-07-31
Liver Incytes, Model 10052020-07-31
Navigation Enabled Intruments2020-07-31
P Pro Crown & Bridge2020-07-31
Reprocessed Endoscopic Trocars And Sleeves2020-07-31
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge2020-07-31
VibrantVue Scleral Saline2020-07-31
XPORT 304 (miCOR) System Lens Fragmentation System2020-07-31
AI-Rad Companion Prostate MR2020-07-30
Arthrex Mini Hip PushLock2020-07-30
BD Univia RightFit Enteral Extension Sets And Transitional Adapters2020-07-30
EXULT Femoral Component Trial - Left, EXULT Femoral Component Trial - Right2020-07-30
FractureDetect (FX)2020-07-30
HI-TORQUE PROCEED Guide Wire Family2020-07-30
Joimax Intracs System2020-07-30
KY Grosz Jelly2020-07-30
MAGEC® System2020-07-30
MEDRAD Imaging Bulk Package Transfer Spike2020-07-30
MY01 Continuous Compartmental Pressure Monitor2020-07-30
OSSIOfiber™ Compression Screws2020-07-30
PENTAX Medical Video Bronchoscope EB-J10 Series2020-07-30
Reprocessed NRG Transseptal Needle2020-07-30
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System2020-07-30
Safey Peak Flow Meter2020-07-30
Safey Pocket Spirometer2020-07-30
SpeediCath Soft2020-07-30
Sterispine™ PS2020-07-30
Pitkar External Fixation System - Rail Mechanism2020-07-29
PNEUMOCLEAR2020-07-29
Superpipe Angiographic Catheter2020-07-29
Symphony2020-07-29
Zoom 14 Guidewire2020-07-29
Bioflux Software II2020-07-29
Biolox® Delta Ceramic Heads, Biolox® Delta Option Ceramic Heads MR Labeling2020-07-29
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2020-07-29
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote2020-07-29
BoniPlus Dental G-Mesh System2020-07-29
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown2020-07-29
DemeMASK2020-07-24
Tempus LS - Manual2020-07-24
Disposable Temperature Probe2020-07-24
DePuy Synthes 2.7mm VA LCP Clavicle Plate System2020-07-24
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous2020-07-24
Arthrex SutureTape2020-07-24
Extremely Thin 003, ZERO ZERO THREE2020-07-24
Single Use Electrosurgical Knife2020-07-24
Transept Cervical Plate System2020-07-24
Ureterorenoscope System2020-07-24
JUSHA-CP610 LCD Monitor2020-07-24
Aer X2020-07-24
LG Pra. L Derma LD Scalp Care2020-07-23
Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors2020-07-23
Vivid E80/ Vivid E90/ Vivid E952020-07-23
Microlife Upper Arm Automatic Digital Blood Pressure Monitor2020-07-23
AVVIGO Guidance System2020-07-23
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)2020-07-23
1717SCV, 1717SGV2020-07-23
Canon Non-mydriatic Retinal Camera CR Series2020-07-23
EVA 15 Insufflator2020-07-23
Pre-Seed™ Fertility Lubricant2020-07-23
True Tulip System, True M.I.S. System2020-07-22
Endomat Select, IBS Shaver Software, License2020-07-22
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor2020-07-22
Picowon2020-07-22
8ch Flex Suite2020-07-22
Caption Interpretation Automated Ejection Fraction Software2020-07-22
EVOS Straight Proximal Humerus 7-15 Hole Plates (137-225mm)2020-07-22
Duranext Abutments2020-07-22
Rubicon SA System2020-07-22
SOMATOM On.site And On.scene2020-07-22
Visera Elite II Video System Center2020-07-22
Gamma3 System2020-07-22
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 Mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 Mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 Mm2020-07-22
DAC Dynamic Active Compression Plate2020-07-22
Empty EVA Bag2020-07-22
InMode RF Multi-System2020-07-22
Pedicle Screw System2020-07-22
Reprocessed BRK Transseptal Needle2020-07-22
3DMax MID Anatomical Mesh2020-07-17
AeroEclipse* ONE BAN2020-07-17
Ambu Duodeno System2020-07-17
Cryocheck Chromogenic Factor VIII2020-07-17
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I2020-07-17
LINK TrabecuLink Femoral Cones2020-07-17
MyQA ION2020-07-17
Phantom® Hindfoot TTC/TC Nail System2020-07-17
Rover2020-07-17
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable2020-07-17
SCENARIA View2020-07-17
Signia Stapler (with New Software)2020-07-17
SuRgical Planner (SRP) BrainStorm2020-07-17
Synvitro Hyadase2020-07-17
Syringe With Safety Needle, Safety Needle2020-07-17
True 3D Viewer2020-07-17
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head2020-07-17
AcuPulse W CO2 Laser Systems, Delivery Devices And Accessories2020-07-16
Arm Blood Pressure Monitor2020-07-16
Barricaid Instrument Tray2020-07-16
FibroScan® 6302020-07-16
Geneva2020-07-16
HealthMammo2020-07-16
Infrared Thermometer Model Number RN-50A,RN-50B2020-07-16
KeraStat Cream2020-07-16
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System2020-07-16
REDUCT® Headless Compression Screw System2020-07-16
TiN Coated Humeral Head2020-07-16
Vivid S60N, Vivid S70N2020-07-16
ZCA All-Poly Acetabular Cups2020-07-16
BD SoloShot Mini Syringe/ BD Auto Disable Syringe2020-07-15
CO2 Laser Therapy System2020-07-15
CoLink Plating System2020-07-15
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens2020-07-15
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage2020-07-15
Encision AEM EnTouch 2X Scissor2020-07-15
FullFocus2020-07-15
Humelock TiN Coated Glenosphere2020-07-15
IHealth Infrared No-Touch Forehead Thermometer2020-07-15
LifeSignals ECG Remote Monitoring Patch Platform2020-07-15
Magicore II System2020-07-15
Nalu Neurostimulation SCS System2020-07-15
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System2020-07-15
V30 System, V20 System, V10 System, V-FR Handpiece2020-07-15
EMBOTRAP III Revascularization Device2020-07-14
AGE Automatic Wrist Blood Pressure Monitor2020-07-12
Automatic Upper Arm Blood Pressure Monitor2020-07-12
AI-Rad Companion Engine2020-07-10
ASSISTO Universal Applicator Clamping Device2020-07-10
Automatic Upper Arm Blood Pressure Monitor2020-07-10
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System2020-07-10
DigitalDiagnost C502020-07-10
Disposable Specimen Retrieval Bag2020-07-10
DreamStation 2 System, DreamStation 2 Advanced System2020-07-10
Eclipse Treatment Planning System V16.12020-07-10
ExcelsiusGPS Cranial 1.0 Module2020-07-10
Ezra Plexo Software2020-07-10
HD Steth2020-07-10
Infrascanner2020-07-10
NextAR TKA Platform2020-07-10
Paragon 28 APEX 3D Total Ankle Replacement System2020-07-10
Pelvital System2020-07-10
Resoundant Acoustic Driver System2020-07-10
SmartLinx Vitals Plus Patient Monitoring System2020-07-10
Sonicision Cordless Ultrasonic Dissector2020-07-10
Triathlon Total KneeSystem2020-07-10
X-Cube 702020-07-10
X-Cube 902020-07-10
DuraDiagnost2020-07-09
ETHICON Linx Esophagus Sizing Tool2020-07-09
GC Temp Print2020-07-09
GTK Trocars2020-07-09
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)2020-07-09
I-Rapha Solution2020-07-09
Optiflux Enexa F500 Dialyzer2020-07-09
Rapid LVO2020-07-09
SR-8100 Portable X-ray Unit2020-07-09
XACT Robotic System2020-07-09
Zimmer, Inc. Hip Joint Prostheses MR Labeling I2020-07-09
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2020-07-09
ABRO 1, RESITON GINGIVA, PRIME And THERAPON TRANSPA2020-07-08
ACTIV.A.C. Negative Pressure Wound Therapy System2020-07-08
Arthrex DynaNite Compression Plate2020-07-08
Arthrex Eclipse Shoulder Prosthesis System2020-07-08
B&J DVT Compression Devices MHH800/MHH800SQ2020-07-08
CAPERE Thrombectomy System2020-07-08
CMDR 2C (Multiple Models)2020-07-08
Delta Multihole TT Pro Acetabular System2020-07-08
Dental Glass Ceramics Blocks2020-07-08
Digital Thermometer2020-07-08
Intraosseous Fixation System2020-07-08
Looking Glass 4K Integrated Visualization System2020-07-08
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2020-07-08
VisCalor2020-07-08

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