Search FDA 510(k) Database

7,157 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22369–22392 of 174,061
Cleared Dec 19, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K183223 · OZZ
Diasorin Molecular, LLC
Microbiology · 29d
Cleared Dec 19, 2018
CoreLink F3D™ Lateral System
K183239 · MAX
Corelink, LLC
Orthopedic · 29d
Cleared Dec 18, 2018
REVEL Spacers
K180909 · ODP
Globus Medical, Inc.
Orthopedic · 256d
Cleared Dec 18, 2018
Apex Locator, DPEX III
K181087 · LQY
Guilin Woodpecker Medical Instrument...
Dental · 237d
Cleared Dec 18, 2018
VINTAGE PRO
K181496 · EIH
Shofu Dental Corporation
Dental · 194d
Cleared Dec 18, 2018
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · FCG
Apriomed AB
Gastroenterology & Urology · 169d
Cleared Dec 18, 2018
Devon 52 Sequential Compression Device
K182150 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 132d
Cleared Dec 18, 2018
Arthrex Compression FT Screws
K182361 · HWC
Arthrex, Inc.
Orthopedic · 110d
Cleared Dec 18, 2018
Lucitone Denture Base Materials
K182422 · EBI
Dentsply Sirona
Dental · 103d
Cleared Dec 18, 2018
NuFACE FIX Skin Toning Device
K182424 · NFO
Carol Cole Company Dba Nuface
Neurology · 103d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593 · JIN
Apex BioTechnology Corp.
Chemistry · 89d
Cleared Dec 18, 2018
HERA W10 Diagnostic Ultrasound System
K182595 · IYN
Samsung Medison Co., Ltd.
Radiology · 89d
Cleared Dec 18, 2018
MIM - MRT Dosimetry
K182624 · LLZ
Mim Software, Inc.
Radiology · 85d
Cleared Dec 18, 2018
SKR 3000
K182688 · MQB
Konica Minolta, Inc.
Radiology · 83d
Cleared Dec 18, 2018
EliA RF IgM Immunoassay
K182747 · DHR
Phadia AB
Immunology · 81d
Cleared Dec 18, 2018
Integra Salto Total Ankle System
K182878 · HSN
Ascension Orthopedics
Orthopedic · 64d
Cleared Dec 18, 2018
Emission Computed Tomography System
K182938 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Dec 18, 2018
AURORA™ Screw System
K182989 · HWC
MiRus, LLC
Orthopedic · 50d
Cleared Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Dec 18, 2018
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · GBM
Hollister Incorporated
Gastroenterology & Urology · 27d
Cleared Dec 17, 2018
Handheld VitalSigns Monitoring System
K172965 · MWI
Visiomed Technology Co.,Ltd
Cardiovascular · 447d
Cleared Dec 17, 2018
Met One Czar Anterior Cervical Plate System
K180772 · KWQ
Met One Technologies
Orthopedic · 269d
Cleared Dec 17, 2018
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid...
K180878 · DJC
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 258d
Cleared Dec 17, 2018
Tyto Stethoscope (OTC)
K181612 · DQD
Tyto Care , Ltd.
Cardiovascular · 181d