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
33289–33312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2015
Molteno3 Glaucoma Implant
K152996 · KYF
Innovative Ophthalmic Products, Inc....
Ophthalmic · 65d
Cleared Dec 17, 2015
Beacon Tissue Marker (SE)
K153189 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 44d
Cleared Dec 17, 2015
Klassic Knee System
K153310 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared Dec 17, 2015
Asahi REXEED-S Series Dialyzer
K153344 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Dec 16, 2015
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue...
K150524 · NLQ
Surgical Instrument Services and...
General & Plastic Surgery · 289d
Cleared Dec 16, 2015
PulseFlowDF
K150806 · JOW
Pulseflow Technologies
Cardiovascular · 265d
Cleared Dec 16, 2015
XM-01 Electronic Automatic Blood Pressure Monitor
K150908 · DXN
Sky Innovation Technology ( Shanghai)...
Cardiovascular · 257d
Cleared Dec 16, 2015
Vios Monitoring System
K150992 · DRT
Vios Medical, Inc.
Cardiovascular · 245d
Cleared Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
K151279 · NUH
Counter Scientific Development (Gz),...
Neurology · 216d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,...
K151840 · DQX
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Dec 16, 2015
Zenostar MT, Zenostar Color Liquids
K152118 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 139d
Cleared Dec 16, 2015
Resolve 2.0
K152322 · PME
Denali Corporation
Dental · 121d
Cleared Dec 16, 2015
AquaShield system CO2, AquaShield system-PENTAX
K153362 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 16, 2015
Advanced Perfusion System 1
K153376 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 23d
Cleared Dec 16, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153450 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 16d
Cleared Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
K153480 · IYN
Philips Health Care
Radiology · 14d
Cleared Dec 15, 2015
Monitor B40
K151063 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 239d
Cleared Dec 15, 2015
Latitude-C Cervical Interbody Spacer System
K151496 · ODP
Degen Medical
Orthopedic · 195d
Cleared Dec 15, 2015
Remedy® Shoulder Spacer
K152267 · KWS
Osteoremedies, LLC
Orthopedic · 126d
Cleared Dec 15, 2015
8X-10-XXXX Camera System
K152513 · GCJ
Santa Barbara Imaging Systems
General & Plastic Surgery · 104d
Cleared Dec 15, 2015
AccuLIF TL and PL Cage
K152651 · MAX
Stryker Corporation
Orthopedic · 90d
Cleared Dec 15, 2015
Alevicyn SG Antipruritic Gel
K152945 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 70d
Cleared Dec 15, 2015
Balloon controller PB-30
K153483 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 12d
Cleared Dec 14, 2015
V-STEADY, V-FAST
K150408 · LOD
G21, S.R.L.
Orthopedic · 299d