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
32593–32616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2016
Cryotop US
K153027 · MQK
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 150d
Cleared Mar 14, 2016
Bundled Neurological Shunts and Accessories Product Families Labeling...
K153041 · JXG
Integra LifeSciences Corporation
Neurology · 147d
Cleared Mar 14, 2016
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital...
K153119 · KPR
Summit Industries, LLC
Radiology · 137d
Cleared Mar 14, 2016
Reprocessed Electrophysiology Catheter
K153153 · NLH
Innovative Health, LLC
Cardiovascular · 133d
Cleared Mar 14, 2016
Sleep Profiler
K153412 · OLZ
Advanced Brain Monitoring, Inc.
Neurology · 110d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661 · LYR
Meridian Bioscience, Inc.
Microbiology · 84d
Cleared Mar 14, 2016
MicroMatrix
K153754 · KGN
Acell, Inc.
General & Plastic Surgery · 76d
Cleared Mar 13, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · DXN
Health & Life Co., Ltd.
Cardiovascular · 52d
Cleared Mar 11, 2016
BellaFuse
K151271 · MQV
Hans Biomed Corp.
Orthopedic · 303d
Cleared Mar 11, 2016
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · NFB
Salter Labs
Anesthesiology · 281d
Cleared Mar 11, 2016
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · LJM
Immco Diagnostics, Inc.
Immunology · 275d
Cleared Mar 11, 2016
chromID MRSA
K151688 · JSO
bioMerieux, Inc.
Microbiology · 262d
Cleared Mar 11, 2016
Clean & More
K151748 · PIP
3M Deutschland GmbH
Dental · 256d
Cleared Mar 11, 2016
CAAS Workstation
K151780 · IZI
Pie Medical Imaging BV
Radiology · 254d
Cleared Mar 11, 2016
Dentti System
K151965 · NXC
Martz, Inc.
Dental · 239d
Cleared Mar 11, 2016
StimQ Peripheral Nerve Stimulator (PNS) System
K152178 · GZF
Stimq, LLC
Neurology · 220d
Cleared Mar 11, 2016
Rapicide PA High-Level Disinfectant Test Strips
K152394 · JOJ
Medivators, Inc.
General Hospital · 200d
Cleared Mar 11, 2016
SYLK PERSONAL LUBRICANT
K152646 · NUC
Toro Management, LLC Dba Sylk
Obstetrics & Gynecology · 177d
Cleared Mar 11, 2016
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
K160064 · QYX
Infobionic, Inc.
Cardiovascular · 58d
Cleared Mar 11, 2016
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV...
K160374 · FOZ
Tangent Medical Technologies, Inc.
General Hospital · 30d
Cleared Mar 11, 2016
NovaCross Microcatheter
K160389 · DQY
Nitiloop , Ltd.
Cardiovascular · 29d
Cleared Mar 11, 2016
Surefire Infusion System
K160662 · DQO
Surefire Medical, Inc.
Cardiovascular · 2d
Cleared Mar 10, 2016
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control...
K142993 · DCK
Orion Diagnostica, OY
Immunology · 511d
Cleared Mar 10, 2016
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2...
K151421 · CCK
Salter Labs
Anesthesiology · 287d