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
35281–35304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2015
OSTEOTEC SILICONE FINGER IMPLANT
K140453 · KYJ
Osteotec, Ltd.
Orthopedic · 417d
Cleared Apr 17, 2015
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
K140506 · NUC
Turkuaz Saglik Hizmetleri Medikal...
Obstetrics & Gynecology · 414d
Cleared Apr 17, 2015
EUROIMMUN IFA 40: HEP-20-10
K141827 · DHN
Euroimmun Us, Inc.
Immunology · 284d
Cleared Apr 17, 2015
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
K142083 · OZT
C.R. Bard, Inc.
Cardiovascular · 260d
Cleared Apr 17, 2015
OXYTOTE INFINITY SERIES VIPR SYSTEMS
K142149 · ECX
Western/Scott Fetzer Co.
Anesthesiology · 255d
Cleared Apr 17, 2015
DIODE LASER HAIR REMOVAL SYSTEM
K142186 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 252d
Cleared Apr 17, 2015
RAYSCAN A-EXPERT 3D
K142247 · OAS
Ray Co., Ltd.
Radiology · 262d
Cleared Apr 17, 2015
SCANIP
K142779 · LLZ
Simpleware , Ltd.
Radiology · 203d
Cleared Apr 17, 2015
MindChild Meridian M100 Fetal Heart Rate Monitor
K142883 · HGM
Mindchild Medical
Obstetrics & Gynecology · 197d
Cleared Apr 17, 2015
Exam Vue DR
K142930 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 190d
Cleared Apr 17, 2015
SagiNova
K142986 · JAQ
Eckert & Ziegler Bebig GmbH
Radiology · 183d
Cleared Apr 17, 2015
Dilapan-S
K143447 · PKN
Medicem Technology S.R.O
Obstetrics & Gynecology · 136d
Cleared Apr 17, 2015
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
K143599 · DJG
Chemtron Biotech, Inc.
Toxicology · 120d
Cleared Apr 17, 2015
Vitrea CT Myocardial Perfusion
K150104 · JAK
Vital Images, Inc.
Radiology · 87d
Cleared Apr 17, 2015
GammaBeam 500
K150191 · IWB
Best Theratronics Limited
Radiology · 79d
Cleared Apr 17, 2015
ProCinch Adjustable Loop Device
K150416 · HTY
Stryker Endoscopy
Orthopedic · 58d
Cleared Apr 17, 2015
Vantage Titan 1.5T, V3.1, MRT-1510
K150427 · LNH
Toshibamedical Systems Corporation
Radiology · 57d
Cleared Apr 17, 2015
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
K150430 · DXN
Fudakang Industrial Co., Ltd.
Cardiovascular · 57d
Cleared Apr 17, 2015
UnicLine Mobile
K150490 · EIA
Heka Dental A/S
Dental · 51d
Cleared Apr 17, 2015
SI-BONE iFuse Implant System
K150714 · OUR
SI-BONE, Inc.
Orthopedic · 29d
Cleared Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
K133002 · DHA
Abbott Point of Care, Inc.
Chemistry · 569d
Cleared Apr 16, 2015
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
K141880 · KKY
Ceremed , Inc.
General & Plastic Surgery · 279d
Cleared Apr 16, 2015
QANS (Quantitative Autonomic Nervous System) Monitoring System
K142551 · DPS
Hhssystems, LLC
Cardiovascular · 218d
Cleared Apr 16, 2015
Option (TM) ELITE Vena Cava Filter 100cm System
K143405 · DTK
Rex Medical, L.P.
Cardiovascular · 139d