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
30817–30840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2016
Standard Clamp
K161720 · GCJ
Standard Bariatrics
General & Plastic Surgery · 124d
Cleared Oct 24, 2016
Automatic Arm Bluetooth Blood Pressure Monitor
K161846 · DXN
Truly Instrument Limited
Cardiovascular · 111d
Cleared Oct 24, 2016
Ahmed Glaucoma Valve
K162060 · KYF
New World Medical, Inc.
Ophthalmic · 90d
Cleared Oct 21, 2016
KJ Mini Implant System
K151970 · DZE
Kj Meditech Co., Ltd.
Dental · 463d
Cleared Oct 21, 2016
NOSOGARD FILTERS
K153784 · NHV
Evoqua Water Technologies, LLC
Gastroenterology & Urology · 295d
Cleared Oct 21, 2016
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
K160187 · DQK
St Jude Medical
Cardiovascular · 268d
Cleared Oct 21, 2016
SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
K160294 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 261d
Cleared Oct 21, 2016
Xenco Medical Cervical Interbody System
K160313 · OVE
Xenco Medical, LLC
Orthopedic · 259d
Cleared Oct 21, 2016
MAGEC® Spinal Bracing and Distraction System
K160352 · PGN
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 256d
Cleared Oct 21, 2016
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz...
K160442 · IYN
Neural Analytics, Inc.
Radiology · 247d
Cleared Oct 21, 2016
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH...
K160541 · JLW
Sysmex America, Inc.
Chemistry · 238d
Cleared Oct 21, 2016
HPM-6000
K160992 · IPF
BTL Industries, Inc.
Physical Medicine · 196d
Cleared Oct 21, 2016
MiniBox +
K161295 · BZC
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 165d
Cleared Oct 21, 2016
Ambient HipVac 50 Wand with Integrated Finger Switches
K161481 · GEI
ArthroCare Corporation
General & Plastic Surgery · 143d
Cleared Oct 21, 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · PGW
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 137d
Cleared Oct 21, 2016
CapsoCam Plus (SV-3) Capsule Endoscope System
K161773 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 115d
Cleared Oct 21, 2016
TRAcelet Compression Device
K162027 · DXC
Medtronic Vascular
Cardiovascular · 91d
Cleared Oct 21, 2016
M.U.S.T. Pedicle Screw System
K162061 · NKB
Medacta International S.A.
Orthopedic · 87d
Cleared Oct 21, 2016
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens,...
K162317 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 63d
Cleared Oct 21, 2016
Artemis
K162474 · LLZ
Eigen
Radiology · 45d
Cleared Oct 21, 2016
Gentrix Surgical Matrix
K162554 · FTM
Acell, Inc.
General & Plastic Surgery · 38d
Cleared Oct 21, 2016
Distal Radius Plating System
K162635 · HRS
Miami Device Solutions, LLC
Orthopedic · 30d
Cleared Oct 21, 2016
Paragon 2
K162687 · IZL
Meridian Medical Systems, LLC
Radiology · 24d
Cleared Oct 20, 2016
aoni Natural Rubber Latex Condom
K153016 · HIS
Guangzhou Daming United Rubber...
Obstetrics & Gynecology · 371d