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
20305–20328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2020
KY Grosz UltraGel
K192982 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 172d
Cleared Apr 14, 2020
Vapocoolshot Mist
K193349 · MLY
Vapocoolshot, Inc.
Physical Medicine · 133d
Cleared Apr 14, 2020
Dermapose Refresh
K193363 · MUU
Puregraft, LLC
General & Plastic Surgery · 132d
Cleared Apr 14, 2020
Xelis Dental 2.0
K193369 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 131d
Cleared Apr 14, 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
K200388 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 56d
Cleared Apr 14, 2020
Stat Profile Prime Plus Analyzer System
K200403 · JGS
Nova Biomedical Corporation
Chemistry · 55d
Cleared Apr 14, 2020
JiveX
K200703 · LLZ
Visus Health IT GmbH
Radiology · 27d
Cleared Apr 13, 2020
CuraRad-ICH
K192167 · QAS
Curacloud Corp.
Radiology · 248d
Cleared Apr 13, 2020
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium...
K192838 · DWA
Spectrum Medical , Ltd.
Cardiovascular · 193d
Cleared Apr 13, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K192850 · KFM
Qura S.R.L
Cardiovascular · 193d
Cleared Apr 13, 2020
ND:YAG Laser
K193464 · GEX
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 119d
Cleared Apr 13, 2020
s-Clean SQ-SL Implant System Mini
K200099 · DZE
Dentis Co., Ltd.
Dental · 88d
Cleared Apr 13, 2020
ADVIA Centaur CEA Assay
K200215 · DHX
Siemens Healthcare Disgnostics, Inc.
Immunology · 76d
Cleared Apr 13, 2020
VivAer Stylus
K200300 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 67d
Cleared Apr 13, 2020
AcuityPDR
K200726 · IZL
Radmedix, LLC
Radiology · 24d
Cleared Apr 12, 2020
VERASENSE for Stryker Triathlon
K200665 · ONN
Orthosensor, Inc.
Orthopedic · 30d
Cleared Apr 11, 2020
Nerve and Muscle Stimulator
K193275 · IPF
Shenzhen Xft Medical Limited
Physical Medicine · 137d
Cleared Apr 10, 2020
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
K190353 · PLC
Residential Home Sleep Services
Dental · 420d
Cleared Apr 10, 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single...
K192679 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 197d
Cleared Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition...
K193215 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 10, 2020
SIGNA Premier
K193282 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 109d
Cleared CT Apr 10, 2020
SkinStylus SteriLock MicroSystem
K200044 · QAI
Esthetic Education, LLC
General & Plastic Surgery · 93d
Cleared Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with...
K200072 · LZA
Kimberly Clark Corporation
General Hospital · 87d