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
29089–29112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2017
Humeris Shoulder
K163669 · PHX
Fx Solutions
Orthopedic · 141d
Cleared May 17, 2017
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT...
K170078 · IYN
Medisono, LLC
Radiology · 128d
Cleared May 17, 2017
Test of Variables of Attention (T.O.V.A.) Version 9.0
K170082 · LQD
The Tova Company
Neurology · 127d
Cleared May 17, 2017
QuantX
K170195 · LLZ
Quantitative Insights, Inc.
Radiology · 114d
Cleared May 17, 2017
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K170196 · DXN
A&D Company, Ltd.
Cardiovascular · 114d
Cleared May 17, 2017
Cardiac Trigger Monitor
K170828 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 58d
Cleared May 17, 2017
Nexus DR Digital X-ray Imaging System
K171138 · MQB
Varex Imaging Corporation
Radiology · 29d
Cleared May 17, 2017
Surefire Precision Infusion System
K171355 · DQO
Surefire Medical, Inc.
Cardiovascular · 8d
Cleared May 16, 2017
VerteFIT Corpectomy Cage System
K162133 · MQP
Ldr Spine USA, Inc.
Orthopedic · 288d
Cleared May 16, 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · KNT
Covidien (Dba Medtronic)
Gastroenterology & Urology · 200d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared May 16, 2017
EPIC Extremely Small Staple
K163226 · JDR
Epic Extremely, LLC
Orthopedic · 180d
Cleared May 16, 2017
iSR'obot Biopsy Kit
K163502 · ITX
Biobot Surgical Pte., Ltd.
Radiology · 153d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Boston Scientific Corporation
Cardiovascular · 138d
Cleared May 16, 2017
DSM Biomedical Dental Bone Graft
K170245 · NPM
Kensey Nash Corporation Dba Dsm...
Dental · 110d
Cleared May 16, 2017
A-View
K170338 · ITX
Stroke2prevent B.V.
Radiology · 103d
Cleared May 16, 2017
KARL STORZ ShuntScope
K170462 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 90d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · PQZ
Hardy Diagnostics
Microbiology · 89d
Cleared May 16, 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · NKB
Stryker Corporation
Orthopedic · 88d
Cleared May 16, 2017
SIROLaser Advance+
K170500 · GEX
Dentsply Sirona
General & Plastic Surgery · 84d
Cleared May 16, 2017
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K170575 · LYZ
Ever Global (Vietnam) Enterprise Corp
General Hospital · 78d
Cleared May 16, 2017
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K170680 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 71d
Cleared May 16, 2017
Arthrex Knotless SutureTak Anchor
K171020 · MBI
Arthrex, Inc.
Orthopedic · 41d
Cleared May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
K171168 · JIT
Ortho-Clinical Diagnostics
Chemistry · 25d