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
33889–33912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2015
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split...
K152025 · DJR
Assure Tech. Co., Ltd.
Chemistry · 75d
Cleared Oct 02, 2015
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE...
K141656 · NBW
Philosys, Inc.
Chemistry · 469d
Cleared Oct 02, 2015
Valeo Spacer System and Valeo II Interbody Fusion Device System
K143518 · MAX
Amedica Corp.
Orthopedic · 294d
Cleared Oct 02, 2015
SICAT OPTIMOTION
K143655 · MQC
Sicat GmbH & Co. KG
Dental · 283d
Cleared Oct 02, 2015
One Step hCG Pregnancy Test
K150063 · LCX
Coretests, Inc.
Chemistry · 262d
Cleared Oct 02, 2015
ARGOS
K150754 · MXK
Santec Corporation
Ophthalmic · 193d
Cleared Oct 02, 2015
CorPath 200 System
K150892 · DXX
Corindus, Inc.
Cardiovascular · 183d
Cleared Oct 02, 2015
zensor system
K151027 · MHX
Intelesens Limited
Cardiovascular · 168d
Cleared Oct 02, 2015
LOSPA IS Spinal System
K151408 · MAX
Corentec Co., Ltd.
Orthopedic · 129d
Cleared Oct 02, 2015
OrthoVis Web Portal
K151501 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 120d
Cleared Oct 02, 2015
iSy Implant System
K151599 · DZE
Altatec GmbH
Dental · 112d
Cleared Oct 02, 2015
TiTHON Staple with OsseoTi Technology
K151615 · JDR
Biomet Manufacturing Corp
Orthopedic · 109d
Cleared Oct 02, 2015
Disposable Insulin Syringe
K151949 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 79d
Cleared Oct 02, 2015
Extended Range Shifter for PROBEAT-V
K152207 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 57d
Cleared Oct 02, 2015
Elecsys Progesterone III CalSet
K152526 · JIT
Roche Diagnostics
Chemistry · 29d
Cleared Oct 02, 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 24d
Cleared Oct 01, 2015
SIS Inguinal Hernia Repair Graft
K142887 · FTM
Cook Biotech Incorprated
General & Plastic Surgery · 364d
Cleared Oct 01, 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i...
K143515 · NHA
Prismatik Dentalcraft, Inc.
Dental · 294d
Cleared Oct 01, 2015
hemoFISH Masterpanel
K150031 · JSS
Miacom Diagnostics GmbH
Microbiology · 266d
Cleared Oct 01, 2015
EPX-4440HD and EPX-4400HD with FICE
K150221 · FET
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 244d
Cleared Oct 01, 2015
3M Comply Hydrogen Peroxide Indicator Tape 1228
K150694 · JOJ
3M Company
General Hospital · 197d
Cleared Oct 01, 2015
VISERA 4K UHD SYSTEM
K151011 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 169d
Cleared Oct 01, 2015
Synergy ODM
K151952 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 78d
Cleared Oct 01, 2015
SonoStik IV Guide Wire Introducer
K152177 · DYB
Sonostik, LLC
Cardiovascular · 58d