Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
32233–32256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2016
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
K153050 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 189d
Cleared Apr 26, 2016
Genesys Spine Apache Interbody Fusion System
K153123 · MAX
Genesys Spine
Orthopedic · 180d
Cleared Apr 26, 2016
2008K2 Hemodialysis Machine
K153449 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared Apr 26, 2016
Inertia Pedicle Screw and Deformity Correxxion System
K153453 · NKB
Nexxt Spine, LLC
Orthopedic · 148d
Cleared Apr 26, 2016
Materialise Glenoid Positioning System
K153602 · KWS
Materialise NV
Orthopedic · 131d
Cleared Apr 26, 2016
Voluson P6, Voluson P8
K160162 · IYN
Ge Healthcare
Radiology · 90d
Cleared Apr 26, 2016
Signia Stapler
K160176 · GDW
Covidien
General & Plastic Surgery · 90d
Cleared Apr 26, 2016
StarFuse Interphalangeal Pin
K160194 · HTY
Phalanx Innovations
Orthopedic · 90d
Cleared Apr 26, 2016
White Pearl Preferred Angle Anterior Cervical Plate
K160522 · KWQ
Osseus Fusion Systems, LLC
Orthopedic · 61d
Cleared Apr 26, 2016
PASS OCT Spinal System
K160756 · NKG
Medicrea International SA
Orthopedic · 39d
Cleared Apr 26, 2016
CompactCath Intermittent Urinary Catheter
K160858 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 25, 2016
maxFit II Dental Implant System
K151588 · DZE
Taiwan Implant Technology Company, Ltd.
Dental · 319d
Cleared Apr 25, 2016
MIM-Thin Client (mobile)
K151913 · LLZ
Mim Software, Inc.
Radiology · 287d
Cleared CT Apr 25, 2016
POGO Automatic Blood Glucose Monitoring System
K152493 · NBW
Intuity Medical, Inc.
Chemistry · 237d
Cleared Apr 25, 2016
MMS PTA Balloon Catheter
K152934 · LIT
Micro Medical Solutions, Inc.
Cardiovascular · 203d
Cleared Apr 25, 2016
Stryker Neptune 3 Waste Management System
K153407 · JCX
Stryker Corporation
General Hospital · 152d
Cleared Apr 25, 2016
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
K160285 · OAP
Capillus, LLC
General & Plastic Surgery · 82d
Cleared Apr 22, 2016
MIRI TL
K151357 · MQG
At Medical Uab
Obstetrics & Gynecology · 338d
Cleared Apr 22, 2016
CueSee Hypoxic
K152553 · JJS
Eurotrol B.V.
Chemistry · 227d
Cleared Apr 22, 2016
Matrix Mini ECG Monitor
K152701 · DSI
Global Instrumentation, LLC
Cardiovascular · 214d
Cleared Apr 22, 2016
PASS LP Spinal System
K153413 · NKB
Medicrea International SA
Orthopedic · 149d
Cleared Apr 22, 2016
AvaDent Denture Base Material
K153590 · EBI
Global Dental Science
Dental · 128d
Cleared Apr 22, 2016
OSTEOPAL plus
K153737 · LOD
Heraeus Medical GmbH
Orthopedic · 116d
Cleared Apr 22, 2016
U80 Series Upper Arm Electronic Blood Pressure Monitor
K160019 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 108d