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
INVOS PM7100 Patient Monitor, INVOS Pediatric RSO2 Sensor, INVOS Infant Regional Saturation Sensor (also Referred To As OxyAlert NIRSensor)2021-12-05
Nitrile Powder Free Blue Examination Gloves, Non-Sterile2021-12-04
Adapter Sleeve For BIOLOX® OPTION Femoral Head, +10.5mm Head Length2021-12-03
AHI System2021-12-03
ArtiSential Trocar2021-12-03
Cydar EV (Series B) And Cydar EV Maps2021-12-03
Everyway Incontinence Stimulation System2021-12-03
Independent Corneal Viewing Chamber (IVC-21)2021-12-03
Inspan ScrewLES Fusion System2021-12-03
Medline Cardiovascular Procedure Kit2021-12-03
Molecular Flow Simulations2021-12-03
PVmed Contouring Software2021-12-03
Solero Microwave Tissue Ablation (MTA) System And Accessories2021-12-03
Surgical Masks2021-12-03
Aimanfun Lumea Comfort, A-2789/A-35882021-12-02
AURORA Evacuator +Coag2021-12-02
Clivia Series Diagnostic Ultrasound System2021-12-02
FUJIFILM Video Laparoscope EL-R740M302021-12-02
Nitrile Disposable Examination Gloves2021-12-02
OxyLight 2.02021-12-02
Powder Free Nitrile Examination Glove - White, Non-sterile2021-12-02
PS System2021-12-02
Puravita Medical Fold Flat Surgical Mask2021-12-02
Single-use Surgical Mask2021-12-02
AC Cream - Conductive Paste2021-12-01
DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T2021-12-01
Electric Breast Pump2021-12-01
Milli Vaginal Dilator2021-12-01
NGM WAVE PLIF Cage2021-12-01
Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)2021-12-01
Powder Free Nitrile Examination Glove- Blue, Non-sterile2021-12-01
Sphincterotome / Short-wire Compatible, Sterile Sphincterotome2021-12-01
Vantage Fortian 1.5T, MRT-1550, V8.0 With AiCE Reconstruction Processing Unit For MR2021-12-01
ALTMS Magnetic Stimulation Therapy System2021-11-26
CUBE Air Purifier2021-11-26
MammoScreen 2.02021-11-26
Medical Surgical Mask2021-11-26
Nitrile Examination Gloves2021-11-26
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula2021-11-26
Synthetic Nitrile Examination Gloves2021-11-26
Tablo Cartridge2021-11-26
Trevo Trak 21 Microcatheter2021-11-26
AMRA Profiler2021-11-24
Atellica CH Enzymatic Creatinine_3 (ECre3)2021-11-24
Bronchoscope System2021-11-24
C-30 Crown Kit2021-11-24
ControlRad Select Model Z2021-11-24
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue2021-11-24
Guiding Catheter2021-11-24
MicroPen EVO2021-11-24
Non-Contact Infrared Thermometer, Model HL710H2021-11-24
Surgical Mask (sterile)2021-11-24
The Radian MIS Bunion System2021-11-24
Xpert Wrist2021-11-24
Arthrex Vortex Threaded Bone Marrow Recovery Needle2021-11-19
BD Nano 2nd Gen Pen Needle2021-11-19
Catalyft LS Expandable Interbody System2021-11-19
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)2021-11-19
EkoSonic Endovascular Device2021-11-19
Frontier Series Power Wheelchairs2021-11-19
HALYARD Flexaprene Green Powder-Free Exam Glove2021-11-19
Leaf Smooth2021-11-19
MR 53002021-11-19
OnQ Neuro2021-11-19
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
Vector® Hammertoe Correction System2021-11-19
Velofix SA Cervical Cage2021-11-19
Capiox ICP Centrifugal Pump2021-11-18
Cardiologs Holter Platform2021-11-18
CoLink Vallux Plating System2021-11-18
Dermalux Flex MD2021-11-18
Desnuda Reflect2021-11-18
Disposable Medical Nitrile Examination Gloves (Non-sterile)2021-11-18
DIXI Medical Microdeep Micro-Macro Depth Electrodes2021-11-18
FAICO Dental Implant System And CAD/CAM Abutments2021-11-18
Gemini 2 810+980 Soft Tissue Laser2021-11-18
HANAROSTENT Esophagus Asymmetric (CCC)2021-11-18
Impertech Surgical Face Mask2021-11-18
IPL Hair Removal, Model: OBT-022021-11-18
LINK® Embrace Shoulder System - Reverse Configuration2021-11-18
MD-320W Ultrasound Biomicroscope2021-11-18
Reprocessed IntellaMap Orion High Resolution Mapping Catheter2021-11-18
Savvy Mask - Level 3 Surgical Face Mask2021-11-18
Stratum® Ankle Fusion Plating System2021-11-18
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System2021-11-18
Water-soluble Personal Lubricant2021-11-18
Arthrex Modular Glenoid System-Titanium Glenosphere2021-11-17
BruxZir Esthetic2021-11-17
Disposable Surgical Mask2021-11-17
Lunit INSIGHT MMG2021-11-17
Promisemed Sharps Container2021-11-17
Protect X Level 3 Isolation Gown2021-11-17
Qora Stool Management Kit2021-11-17
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System2021-11-17
Disposable Surgical Gowns2021-11-13
Surgical Face Mask2021-11-13
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System2021-11-12
DR-HO's Back Pain Relief System Pro (Models BPRS-I And BPRS-II)2021-11-12
Erchonia FX-4052021-11-12
ETEST Fosfomycin (FO) (0.032-512 µg/mL)2021-11-12
HYDRASHIFT 2/4 Isatuximab2021-11-12
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)2021-11-12
Intellijoint VIEW2021-11-12
MAMMOVISTA B.smart2021-11-12
MiPACS HTML5 Web Viewer2021-11-12
NightGuard Flex2021-11-12
Tornier Perform™ Patient-Matched Primary Reversed Glenoid And BLUEPRINT™ Patient Specific Instrumentation2021-11-12
Wrap Accessory Electrodes2021-11-12
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2021-11-12
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)2021-11-11
EnSite X EP System2021-11-11
Nitrile Examination Glove (Powder Free, Blue)2021-11-11
AlignRT Plus2021-11-10
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System2021-11-10
Diode Laser Therapy System2021-11-10
Disposable Automatic Core Biopsy Instrument2021-11-10
EKuore Pro 4T - REF EP00982021-11-10
ESSENZ Patient Monitor2021-11-10
Identity Imprint Cruciate Retaining (CR) Knee Replacement System And Identity Imprint Posterior Stabilized (PS) Knee Replacement System2021-11-10
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector2021-11-10
LTV2 Series Ventilators2021-11-10
Lunit INSIGHT CXR Triage2021-11-10
Powder Free Nitrile Patient Examination Gloves, Blue Color2021-11-10
Venen-trainer (Model: FM150, SFM90)2021-11-10
VSP® Orthopedics System2021-11-10

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