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
34345–34368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2015
Shielded Applicator Set, Cervical Stop
K151657 · JAQ
Varian Medical Systems, Inc.
Radiology · 49d
Cleared Aug 07, 2015
Precision Spine Interspinous Plate System
K151863 · PEK
Precision Spine, Inc.
Orthopedic · 30d
Cleared Aug 07, 2015
STA R MAX
K151867 · JPA
Diagnostica Stago S.A.S
Hematology · 29d
Cleared Aug 07, 2015
MicroTract Access System
K151877 · DRE
Arstasis, Inc.
Cardiovascular · 29d
Cleared Aug 07, 2015
Wingman Crossing Catheter
K151880 · DQY
Reflow Medical
Cardiovascular · 29d
Cleared Aug 07, 2015
Q-Rad Radiographic System with Auto-Tracker Option
K151924 · KPR
Quantum Medical Imaging Divison of...
Radiology · 25d
Cleared Aug 07, 2015
Confida Adaptive Sheath
K152054 · DYB
Medtronic, Inc.
Cardiovascular · 15d
Cleared Aug 06, 2015
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring...
K142689 · CGA
Apex BioTechnology Corp.
Chemistry · 318d
Cleared Aug 06, 2015
Elecsys CA-125 II assay
K143534 · LTK
Roche Professional Diagnostics
Immunology · 237d
Cleared CT Aug 06, 2015
Total Knee Application (TKA)
K143752 · OLO
Mako Surgical Corp.
Orthopedic · 218d
Cleared Aug 06, 2015
ReDs Wearable System
K150095 · DSB
Sensible Medical Innovations , Ltd.
Cardiovascular · 202d
Cleared Aug 06, 2015
EUM 100Pro
K150398 · HGM
Ob Tools, Ltd.
Obstetrics & Gynecology · 169d
Cleared Aug 06, 2015
Reveal LINQ
K150614 · MXD
Medtronic, Inc.
Cardiovascular · 149d
Cleared Aug 06, 2015
Triglycerides
K150819 · CDT
Randox Laboratories Limited
Chemistry · 132d
Cleared Aug 06, 2015
O-Arm O2 Imaging System
K151000 · OWB
Medtronic, Inc.
Radiology · 113d
Cleared Aug 06, 2015
Cornea Cold
K151061 · LYX
Eurobio
Ophthalmic · 108d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 100d
Cleared Aug 06, 2015
VIKINI Diode Laser System
K151232 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 90d
Cleared Aug 06, 2015
Medline Foot Plates and Screws
K151235 · HRS
Medline Industries, Inc.
Orthopedic · 87d
Cleared Aug 06, 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP...
K151374 · MAX
Nu Vasive, Incorporated
Orthopedic · 76d
Cleared Aug 06, 2015
Penumbra System 110 Aspiration Tubing
K151623 · NRY
Penumbra, Inc.
Neurology · 51d
Cleared Aug 06, 2015
Resolution Clip
K151802 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 35d
Cleared Aug 06, 2015
ABL80 FLEX CO-OX with AQURE connectivity
K151856 · CHL
Sendx Medical, Inc.
Chemistry · 29d
Cleared Aug 06, 2015
VariAx 2 One-Third Tubular Plating System
K151879 · HRS
Stryker GmbH
Orthopedic · 28d