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
24769–24792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2018
Piccolo Composite® Plate System
K182015 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 76d
Cleared Oct 11, 2018
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary...
K182151 · OVE
Ctl Medical Corporation
Orthopedic · 64d
Cleared Oct 11, 2018
Voyant Electrosurgical Generator
K182244 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 52d
Cleared Oct 11, 2018
Ormco Spark Aligner System
K182826 · NXC
Sybron Dental Specialties
Dental · 6d
Cleared Oct 10, 2018
Cellent Spinal Systems
K172826 · NKB
Jiangsu Trauhui Medical Instrument...
Orthopedic · 387d
Cleared Oct 10, 2018
Temperature Probe
K173194 · FLL
Orantech, Inc.
General Hospital · 373d
Cleared Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7...
K181038 · PSQ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 174d
Cleared Oct 10, 2018
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures
K181774 · GAT
Teleflex Medical Incorporated
General & Plastic Surgery · 99d
Cleared Oct 10, 2018
Elvie Pump
K181863 · HGX
Chiaro Technology Limited
Obstetrics & Gynecology · 90d
Cleared Oct 10, 2018
BioHorizons Tapered IM Implants
K182070 · DZE
BioHorizons Implant Systems, Inc.
Dental · 70d
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 48d
Cleared Oct 10, 2018
Geminus Volar Distal Radius Plate System
K182492 · HRS
Skeletal Dynamics, LLC
Orthopedic · 29d
Cleared Oct 10, 2018
ClotTriever Thrombectomy System
K182531 · QEW
Inari Medical
Cardiovascular · 26d
Cleared Oct 09, 2018
Senhance Surgical System
K181517 · NAY
Transenterix, Inc.
General & Plastic Surgery · 123d
Cleared Oct 09, 2018
Scarlet AL-T
K181818 · OVD
Spineart
Orthopedic · 92d
Cleared Oct 09, 2018
Ziostation2
K181892 · LLZ
Ziosoft, Inc.
Radiology · 88d
Cleared Oct 09, 2018
Swiss LithoClast Trilogy
K182490 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 28d
Cleared Oct 06, 2018
Bluetooth blood pressure monitor
K182018 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 71d
Cleared Oct 06, 2018
Vinyl Patient Examination Gloves
K182117 · LYZ
Jiangxi Zhonghong Pulin Medical...
General Hospital · 61d
Cleared Oct 05, 2018
Straumann SC Variobase Abutments
K173945 · NHA
Institut Straumann AG
Dental · 283d
Cleared Oct 05, 2018
Royal Flush Plus High-Flow Catheter
K180054 · DQO
Cook Incorporated
Cardiovascular · 270d
Cleared Oct 05, 2018
GORE Tri-Lumen Catheter
K180919 · DQY
W. L. Gore and Associates, Inc.
Cardiovascular · 179d