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
18121–18144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2021
Flex-ThreadTM Distal Fibula Intramedullary Nail System
K202858 · HSB
Conventus Orthopaedics, LLC
Orthopedic · 116d
Cleared Jan 22, 2021
Platinum dRF Imaging System
K203010 · JAA
Apelem-Dms Group
Radiology · 113d
Cleared Jan 22, 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000...
K203131 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 95d
Cleared CT Jan 22, 2021
Nerivio, FGD000075-4.7
K203181 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 88d
Cleared Jan 22, 2021
Advanced Research Medical Trident SI Screw System
K203373 · OUR
Advanced Research Medical, LLC
Orthopedic · 67d
Cleared Jan 22, 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 38d
Cleared Jan 21, 2021
pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK...
K200731 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 307d
Cleared Jan 21, 2021
Forwarts
K201366 · GEH
Pronova Laboratories BV
General & Plastic Surgery · 244d
Cleared Jan 21, 2021
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III...
K201758 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 206d
Cleared Jan 21, 2021
DIR 800
K202391 · IZI
Aesculap, Inc.
Neurology · 153d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · QEP
Roche Molecular Systems, Inc.
Microbiology · 153d
Cleared Jan 21, 2021
EEA Circular Stapler with Tri-Staple Technology
K202507 · GDW
Covidien
General & Plastic Surgery · 143d
Cleared Jan 21, 2021
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
K202595 · FXX
Premier Guard USA, LLC
General Hospital · 135d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672 · FPA
Quest Medical, Inc.
General Hospital · 128d
Cleared Jan 21, 2021
Overlapped Compression Therapy
K202839 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 118d
Cleared Jan 21, 2021
Surgical Face Mask
K202904 · FXX
Jiangxi Feilikang Medical Technology...
General Hospital · 114d
Cleared Jan 21, 2021
AEROCURE-MD
K203189 · FRA
Aerobiotix, Inc.
General Hospital · 86d
Cleared Jan 20, 2021
Dentsply Sirona Universal Spray Glazes
K202629 · EIH
Dentsply Sirona
Dental · 131d
Cleared Jan 19, 2021
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
K192913 · KLE
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 462d
Cleared CT Jan 19, 2021
Ava Fertility Tracker
K200163 · LHD
Ava AG
Obstetrics & Gynecology · 363d
Cleared Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219 · KXA
Biocore9, LLC
Orthopedic · 258d
Cleared Jan 19, 2021
Potenza
K201685 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 211d
Cleared Jan 19, 2021
HBP7 Settable Hemostatic Bone Putty
K202363 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 153d
Cleared Jan 19, 2021
Sequel External Fixation Device
K202833 · KTT
Sequel Medical, Inc.
Orthopedic · 116d