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
32737–32760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz...
K160173 · DXK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Feb 26, 2016
LOGIQ S7 Expert
K160182 · IYN
Ge Healthcare
Radiology · 30d
Cleared Feb 26, 2016
Novilase Laser Therapy System, Model LTS-2
K160392 · GEX
Novian Health, Inc.
General & Plastic Surgery · 15d
Cleared Feb 25, 2016
Cogent Lateral Interbody System
K151406 · MAX
Cogent Spine, LLC
Orthopedic · 275d
Cleared Feb 25, 2016
MRCAT
K151435 · MUJ
Philips Medical Systems MR Finland
Radiology · 273d
Cleared Feb 25, 2016
IRENE Locking Compression Plate System
K151508 · HRS
Tianjin Zhengtian Medical Instrument...
Orthopedic · 266d
Cleared Feb 25, 2016
MedicVOD System
K151737 · LLZ
Orpheus Medical , Ltd.
Radiology · 244d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · MDB
Becton, Dickinson and Company
Microbiology · 231d
Cleared Feb 25, 2016
High Pressure Tanning Lamps
K152141 · LEJ
Blv Licht-Und Vakuumtechnik GmbH
General & Plastic Surgery · 206d
Cleared Feb 25, 2016
Perfectio LED infrared device
K152332 · OHS
Omm Imports Inc Dba Zero Gravity
General & Plastic Surgery · 191d
Cleared Feb 25, 2016
ETView VivaSight-SL (TVT) system
K152438 · BTR
Etview , Ltd.
Anesthesiology · 182d
Cleared Feb 25, 2016
LATEX EXAMINATION GLOVE POWDER FREE
K152593 · LYY
Careplus (M) Sdn Bhd
General Hospital · 168d
Cleared Feb 25, 2016
EDS Universal Cement
K152691 · EMA
Essential Dental Systems, Inc.
Dental · 157d
Cleared Feb 25, 2016
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K152715 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 157d
Cleared Feb 25, 2016
SKIN CARE
K152736 · GEX
C.I.S, Ltd.
General & Plastic Surgery · 155d
Cleared Feb 25, 2016
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 135d
Cleared Feb 25, 2016
IMPLANT 3D
K153091 · LLZ
Media Lab S.R.L.
Radiology · 122d
Cleared Feb 25, 2016
VITAL SIGNS MONITOR
K153135 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 118d
Cleared Feb 25, 2016
ASAHI Astato XS 40
K153443 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 90d
Cleared Feb 25, 2016
Occlusion Perfusion Catheter
K153488 · QEY
Advanced Catheter Therapies, Inc.
Cardiovascular · 83d
Cleared Feb 25, 2016
Axxent Electronic Brachytherapy System Model 110 XP 1200
K153570 · JAD
Icad, Inc.
Radiology · 73d
Cleared Feb 25, 2016
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6,...
K153617 · OBJ
Boston Scientific Corporation
Cardiovascular · 69d
Cleared Feb 25, 2016
The Cellfina System
K153677 · OUP
Ulthera, Inc.
General & Plastic Surgery · 66d
Cleared Feb 25, 2016
SIGN Compression Screw System
K153759 · HWC
Sign Fracture Care International
Orthopedic · 57d