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
17425–17448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2021
rainbow CT
K200271 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 16, 2021
Electric Wheelchair (Model: S7110)
K200978 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 368d
Cleared Apr 16, 2021
Fusion Taper System
K201047 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 360d
Cleared Apr 16, 2021
Looper (Model: ZX-579S)
K202055 · OLP
Heat IN A Click, LLC
General & Plastic Surgery · 266d
Cleared Apr 16, 2021
BIOTECH Nitrile Examination Gloves
K202419 · LZA
Tk Hitech Technology Co., Ltd.
General Hospital · 235d
Cleared Apr 16, 2021
Infrared Thermometer Models: DT-8806S, DT-8807S
K203170 · FLL
Shenzhen Everbest Machinery Industry...
General Hospital · 175d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 16, 2021
Brainsway Deep (DTMS) System
K203616 · QMD
Brainsway , Ltd.
Neurology · 127d
Cleared Apr 16, 2021
Hair Growth Device
K210169 · OAP
Dongguan Lescolton Intelligent...
General & Plastic Surgery · 84d
Cleared Apr 16, 2021
Disposable Nitrile Gloves
K210276 · LZA
Fujian Ercon Medical Management Co.,...
General Hospital · 74d
Cleared Apr 16, 2021
MOLLI
K210600 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 46d
Cleared Apr 15, 2021
GD Disposable Medical Face Mask
K201718 · FXX
Jiangsu Guangda Medical Material...
General Hospital · 296d
Cleared Apr 15, 2021
SKORE (Colors & Flavors), SKORE (Colors)
K202403 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 237d
Cleared Apr 15, 2021
Axiostat Patch
K202830 · QSY
Advamedica, Inc.
General & Plastic Surgery · 202d
Cleared Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
K203132 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 178d
Cleared Apr 15, 2021
BLUEPRINT™ Patient Specific Instrumentation
K203315 · KWS
Tornier S.A.S.
Orthopedic · 156d
Cleared Apr 15, 2021
MDPC-8127
K203364 · PSY
Barco N.V.
Pathology · 150d
Cleared Apr 15, 2021
Locator Overdenture Implant System
K203701 · DZE
Ivory Super Holdco Inc. / Zest...
Dental · 118d
Cleared Apr 15, 2021
Verrata PLUS Pressure Guide Wire
K210235 · DQX
Volcano Corporation
Cardiovascular · 77d
Cleared Apr 15, 2021
Edge Insulated Blade Electrode
K210338 · GEI
Covidien, LLC
General & Plastic Surgery · 69d
Cleared Apr 15, 2021
CoreLink Midline Fixation System
K210539 · NKB
Corelink, LLC
Orthopedic · 50d
Cleared Apr 15, 2021
Instylla Microcatheter 1.2
K210808 · KRA
Instylla, Inc.
Cardiovascular · 29d
Cleared Apr 14, 2021
DEFEND Ear-loop Face Masks
K201127 · FXX
Young Dental Manufacturing Co. 1, LLC
General Hospital · 351d
Cleared Apr 14, 2021
AMSure® Single Use Saline Topical Solution
K201138 · FRO
Amsino Medical, Inc.
General & Plastic Surgery · 351d