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
47761–47784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2011
PORTABLE X-RAY SYSTEM
K103600 · EHD
Digimed Corporation
Radiology · 121d
Cleared Apr 08, 2011
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY...
K103672 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 113d
Cleared Apr 08, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
K103759 · NHA
Astra Tech, Inc.
Dental · 106d
Cleared Apr 08, 2011
LP CAGE
K110067 · MAX
Medyssey Co, Ltd.
Orthopedic · 88d
Cleared Apr 08, 2011
TAKE 1 ADVANCED RIGID TRAY
K110092 · ELW
Kerr Corporation
Dental · 86d
Cleared Apr 08, 2011
XEROS DRY MOUTH PUMP
K110116 · LFD
Lorin Technologies Corporation
Dental · 84d
Cleared Apr 08, 2011
ATRICURE BIPOLAR SYSTEM
K110117 · OCL
AtriCure, Inc.
Cardiovascular · 80d
Cleared Apr 08, 2011
PRELUDE III TONGUE SUSPENSION SYSTEM
K110127 · ORY
Siesta Medical, Inc.
Dental · 80d
Cleared Apr 08, 2011
PAIRED HYDROGEL ELECTRODE
K110138 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 80d
Cleared Apr 08, 2011
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
K110147 · HEX
Sti Medical Systems, LLC
Obstetrics & Gynecology · 80d
Cleared Apr 08, 2011
APEX ER. YAG / IPL SYSTEM
K110304 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 65d
Cleared Apr 08, 2011
ATAMA SYSTEM
K110411 · MOS
Monteris Medical, Inc.
Radiology · 53d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · DQX
Boston Scientific Corp
Cardiovascular · 49d
Cleared CT Apr 08, 2011
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT...
K110563 · MVV
Therapeutics 101, Inc (Dba Pressure...
Neurology · 39d
Cleared Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
K110667 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 30d
Cleared Apr 08, 2011
A-CHANNELS LUMBAT SPINE COILS 17
K110802 · LNH
Esaote, S.P.A.
Radiology · 16d
Cleared Apr 08, 2011
AMBIT TUNNELER
K110814 · BSO
Summit Medical Products, Inc.
Anesthesiology · 15d
Cleared Apr 08, 2011
UF-760AG
K110920 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 7d
Cleared Apr 07, 2011
COMBITRANS MONITORING SETS AND ACCESSORIES
K102033 · DRS
B.Braun Melsungen AG
Cardiovascular · 262d
Cleared Apr 07, 2011
UTA AND UHA
K102467 · NHA
Uta
Dental · 220d
Cleared Apr 07, 2011
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
K103318 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 146d
Cleared Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
K110169 · JIT
Siemens Healthcare Diagnostics
Chemistry · 77d
Cleared Apr 07, 2011
EMS AIR-FLOW MASTER PIEZON
K110173 · ELC
E.M.S Electro Medical Systems S.A
Dental · 77d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 76d