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

Filters: Cleared only ×
175,820 results
15649–15672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2021
Vector® Hammertoe Correction System
K213421 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Nov 18, 2021
Capiox iCP Centrifugal Pump
K200091 · KFM
Terumo Cardiovascular Systems...
Cardiovascular · 672d
Cleared Nov 18, 2021
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · GZL
Dixi Medical
Neurology · 478d
Cleared Nov 18, 2021
Gemini 2 810+980 Soft Tissue Laser
K210350 · NVK
Azena Medical, LLC
Dental · 283d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662 · NLG
Innovative Health, LLC
Cardiovascular · 170d
Cleared Nov 18, 2021
FAICO Dental Implant System and CAD/CAM Abutments
K211871 · NHA
Faico Medical, LLC
Dental · 154d
Cleared Nov 18, 2021
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
K211937 · JOW
Jiangsu Synecoun Medical Technology...
Cardiovascular · 149d
Cleared Nov 18, 2021
Desnuda Reflect
K211998 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 143d
Cleared Nov 18, 2021
Medley
K212000 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 143d
Cleared Nov 18, 2021
Impertech Surgical Face Mask
K212046 · FXX
Impertech Industries , Ltd.
General Hospital · 141d
Cleared Nov 18, 2021
Water-soluble Personal Lubricant
K212104 · NUC
Foshan Pingchuang Medical Technology...
Obstetrics & Gynecology · 135d
Cleared Nov 18, 2021
Cardiologs Holter Platform
K212112 · DPS
Cardiologs Technologies
Cardiovascular · 135d
Cleared Nov 18, 2021
Dermalux Flex MD
K212275 · OHS
Aesthetic Technology, Ltd.
General & Plastic Surgery · 121d
Cleared Nov 18, 2021
CoLink Vallux Plating System
K212487 · HRS
In2bones USA, LLC
Orthopedic · 101d
Cleared Nov 18, 2021
Disposable Medical Nitrile Examination Gloves (Non-sterile)
K212600 · LZA
Suqian Linglian Medical Technology...
General Hospital · 93d
Cleared Nov 18, 2021
Stratum® Ankle Fusion Plating System
K212640 · HRS
Nextremity Solutions, Inc.
General Hospital · 90d
Cleared Nov 18, 2021
LINK® Embrace Shoulder System - Reverse Configuration
K212992 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 59d
Cleared Nov 18, 2021
IPL Hair Removal, Model: OBT-02
K213041 · OHT
Glan Electronics Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 18, 2021
MD-320W Ultrasound Biomicroscope
K213070 · IYO
MEDA Co., Ltd.
Radiology · 56d
Cleared Nov 18, 2021
HANAROSTENT Esophagus Asymmetric (CCC)
K213251 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 49d
Cleared Nov 18, 2021
Savvy Mask - Level 3 Surgical Face Mask
K213406 · FXX
Texas Medplast, LLC
General Hospital · 30d
Cleared Nov 18, 2021
VALORY
K213469 · MQB
Agfa N.V.
Radiology · 21d
Cleared Nov 17, 2021
Disposable Surgical Mask
K210042 · FXX
Suzhou Letian Protective Products...
General Hospital · 314d
Cleared Nov 17, 2021
Protect X Level 3 Isolation Gown
K211538 · FYC
Azac Group
General Hospital · 183d