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
30169–30192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2017
SPY Phi Open Field Handheld Fluorescence Imaging System
K162885 · OWN
Novadaq Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Jan 11, 2017
Epic Pro
K163128 · GEX
Biolase, Inc.
General & Plastic Surgery · 64d
Cleared Jan 11, 2017
R2P Metacross RX
K163479 · LIT
KANEKA Corporation
Cardiovascular · 30d
Cleared Jan 10, 2017
Neo GBR System
K160991 · DZL
Neobiotech Co., Ltd.
Dental · 277d
Cleared Jan 10, 2017
osteo-WEDGE II ® Open Wedge Bone Locking Plate System
K162179 · HRS
Graham Medical Technologies, LLC Dba...
Orthopedic · 159d
Cleared Jan 10, 2017
Akros Fibulink Syndesmosis Repair Kit
K162805 · HTN
Akros Medical
Orthopedic · 97d
Cleared Jan 10, 2017
Liquichek Tumor Marker Control-Level 1
K163015 · JJY
Bio-Rad Laboratories
Immunology · 74d
Cleared Jan 10, 2017
EPIQ 5 Diagnostic Ultrasound System
K163120 · IYN
Philips Ultrasound, Inc.
Radiology · 63d
Cleared Jan 10, 2017
Mammomat Fusion with Stereotactic Biopsy
K163252 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Jan 09, 2017
Love Alchemy's Love Lotion
K151857 · NUC
Love Alchemy, LLC
Obstetrics & Gynecology · 551d
Cleared Jan 09, 2017
Ceruloplasmin
K161508 · DDB
Beckman Coulter Ireland, Inc.
Immunology · 222d
Cleared Jan 09, 2017
D2P
K161841 · LLZ
3D Systems, Inc.
Radiology · 188d
Cleared Jan 09, 2017
Bindex BI-2
K161971 · MUA
Bone Index Finland , Ltd.
Radiology · 175d
Cleared Jan 09, 2017
RII Multi-function Infrared Thermometer, Model TH52Z
K162083 · FLL
Radiant Innovation, Inc.
General Hospital · 166d
Cleared Jan 09, 2017
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
K162208 · CFN
Beckman Coulter, Inc.
Immunology · 157d
Cleared Jan 09, 2017
Symbia Intevo Bold
K162483 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jan 09, 2017
Sentinel BreastScan II System
K162767 · LHQ
First Sense Medical, LLC
Radiology · 101d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K162818 · LZA
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...
K162819 · LZA
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 06, 2017
Hospira Extension Set, Hospira Primary Set
K161036 · FPA
Hospira, Inc.
General Hospital · 268d
Cleared Jan 06, 2017
SureClip(TM) Repositionable Hemostasis Clip
K161463 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 225d
Cleared Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K161504 · MPB
Cook Incorporated
Gastroenterology & Urology · 219d
Cleared Jan 06, 2017
MultiStim ECO
K162086 · BXN
PAJUNK GmbH Medizintechnologie
Anesthesiology · 163d
Cleared Jan 06, 2017
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K162181 · DRE
Cardiacassist, Inc.
Cardiovascular · 155d