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
21145–21168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 2020
Air Next
K183089 · BZG
Nuvoair AB
Anesthesiology · 422d
Cleared Jan 02, 2020
Optilume Basic Urological Balloon Dilation Catheter
K191061 · KOE
Urotronic, Inc.
Gastroenterology & Urology · 255d
Cleared Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147 · OOX
Eiken Chemical Co., Ltd.
Hematology · 247d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 216d
Cleared Jan 02, 2020
Sterile LeadConfirm
K191739 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 188d
Cleared Jan 02, 2020
OptoWire III
K191907 · DQX
Opsens, Inc.
Cardiovascular · 170d
Cleared Jan 02, 2020
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
K192216 · ITI
Invacare Corporation
Physical Medicine · 140d
Cleared Jan 02, 2020
Elos Accurate Customized Abutment
K192457 · NHA
Elos Medtech Pinol A/S
Dental · 115d
Cleared Jan 02, 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 104d
Cleared Jan 02, 2020
TunneLoc Tibial Fixation Device
K193092 · MBI
Biomet, Inc.
Orthopedic · 57d
Cleared Jan 02, 2020
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
K193360 · KPR
Radmedix, LLC
Radiology · 29d
Cleared Dec 31, 2019
Digital Thermometer
K190990 · FLL
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 260d
Cleared Dec 31, 2019
Patient Monitor
K192343 · DQA
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 125d
Cleared Dec 31, 2019
mCare® Powder Free Nitrile Black Examination Glove
K192444 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 116d
Cleared Dec 31, 2019
InCore TMT System
K192578 · HWC
Nextremity Solutions, Inc.
Orthopedic · 103d
Cleared Dec 31, 2019
AutoMIStar
K192912 · LLZ
Apollo Medical Imaging Technology...
Radiology · 77d
Cleared Dec 31, 2019
RadCalc Software
K193381 · MUJ
Lifeline Software, Inc.
Radiology · 26d
Cleared Dec 30, 2019
Sterile Latex Surgical Glove, Powder Free
K190241 · KGO
Careglove Global Sdn. Bhd.
General Hospital · 327d
Cleared Dec 30, 2019
Disposable Valve Sets
K192258 · ODC
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 132d
Cleared Dec 30, 2019
Depuy Synthes Maxillofacial Portfolio - MR Conditional
K192655 · JEY
Synthes USA Products, LLC
Dental · 96d
Cleared CT Dec 27, 2019
Masimo Rad-97 and Accessories
K191059 · MWI
Masimo Corporation
Anesthesiology · 249d
Cleared Dec 27, 2019
Straumann BLX Ø3.5 mm Implants
K191256 · DZE
Institut Straumann AG
Dental · 231d
Cleared Dec 27, 2019
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic...
K191696 · OXN
Cook Biotech Incorporated
General & Plastic Surgery · 185d
Cleared Dec 27, 2019
Medical Radiation Dosimetry System microSTARii
K192196 · IYE
Landauer
Radiology · 136d