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
32257–32280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2016
Cascadia Interbody System
K160125 · ODP
K2m
Orthopedic · 93d
Cleared Apr 22, 2016
Gridlock Ankle Plating System
K160177 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 86d
Cleared Apr 22, 2016
Revolution Spinal Fixation System
K160216 · NKB
Intelligent Implant Systems, LLC
Orthopedic · 84d
Cleared Apr 22, 2016
ACCENTO / HWA Dual/Single laser
K160227 · GEX
Bison Medical Co, Ltd.
General & Plastic Surgery · 84d
Cleared Apr 22, 2016
MotoBand(TM) CP Implant System
K160300 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 78d
Cleared Apr 22, 2016
MX50N(MX50YQS)
K160353 · PGY
Wide Corporation
Radiology · 74d
Cleared Apr 22, 2016
Anzai Respiratory Gating System
K160432 · LHN
Anzai Medical Co., Ltd.
Radiology · 66d
Cleared Apr 22, 2016
G3(TM) Active Plate(R) Small Fragment System
K160633 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 46d
Cleared Apr 22, 2016
Reveal LINQ
K160689 · MXD
Medtronic, Inc.
Cardiovascular · 42d
Cleared Apr 22, 2016
Sydney IVF Sperm Cryopreservation Buffer
K160814 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 29d
Cleared Apr 22, 2016
sterEOS Workstation
K160914 · LLZ
Eos Imaging, Inc.
Radiology · 21d
Cleared Apr 21, 2016
Dash-Topic Plus Cream
K150914 · FRO
Founders Science Group, LLC
General & Plastic Surgery · 381d
Cleared Apr 21, 2016
Disposable General Electrode
K152059 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 272d
Cleared Apr 21, 2016
MaxiGen
K152077 · MQV
Hans Biomed Corp.
Orthopedic · 269d
Cleared Apr 21, 2016
Dropper hsCRP High Sensitivity CRP Control
K152117 · JJX
Quantimetrix Corporation
Chemistry · 266d
Cleared Apr 21, 2016
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy...
K152222 · LZC
Gmp Medicare Sdn Bhd (F25)
General Hospital · 258d
Cleared Apr 21, 2016
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
K152365 · NBW
Agamatrix, Inc.
Chemistry · 244d
Cleared Apr 21, 2016
Zavation Spinal System
K153404 · MNH
Zavation, LLC
Orthopedic · 149d
Cleared Apr 21, 2016
Ventix Suture Anchor
K153558 · MBI
Biomet Manufacturing Corp
Orthopedic · 129d
Cleared Apr 21, 2016
PROBEAT-V and accessories
K153614 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 126d
Cleared Apr 21, 2016
MINERAL OIL
K160142 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 91d
Cleared Apr 21, 2016
Laparoscope Lens Shield Device
K160172 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 85d
Cleared Apr 21, 2016
VirtuoSaph Plus Endoscopic Vessel Harvesting System
K160206 · GEI
Terumo Cardiovascular Systems...
General & Plastic Surgery · 84d
Cleared Apr 21, 2016
ULTRA Telescopes
K160249 · HRX
Olympus Winter & Ibe GmbH
Orthopedic · 80d