FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
24121–24144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2018
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
K180863 · BTA
Taidoc Technology Corporation
Ear, Nose, Throat · 261d
Cleared Dec 19, 2018
Modified BrainScope One
K181785 · PIW
Brainscope Company, Inc.
Neurology · 169d
Cleared Dec 19, 2018
BA310 Abutment, BIA310 Implant/Abutment
K182116 · MAH
Cochlear Americas
Ear, Nose, Throat · 135d
Cleared CT Dec 19, 2018
FFRangio System
K182149 · QEK
Cathworks, Ltd.
Cardiovascular · 133d
Cleared Dec 19, 2018
Fetal Doppler
K182190 · KNG
Shenzhen AOJ Medical Technology Co.,...
Obstetrics & Gynecology · 128d
Cleared Dec 19, 2018
TruShot with Y-Knot All-Suture Anchor
K182446 · MBI
Conmed Corporation
Orthopedic · 103d
Cleared Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation...
K182610 · OCL
Medtronic
Cardiovascular · 89d
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