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
35689–35712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2015
IDEAL Locking Plate System
K141825 · HRS
Jiangsu Ideal Medical Science &...
Orthopedic · 239d
Cleared Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · NBW
Roche Diagnostics
Chemistry · 236d
Cleared Mar 03, 2015
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
K143301 · OMP
Integrated Healing Technologies
General & Plastic Surgery · 106d
Cleared Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · JWY
Thermo Fisher Scientific
Microbiology · 193d
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Mar 02, 2015
Mpact Double Mobility System
K143453 · LPH
Medacta International
Orthopedic · 89d
Cleared Mar 02, 2015
GE EchoPAC
K150085 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 46d
Cleared Feb 27, 2015
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
K140990 · ELC
E.M.S Electro Medical Systems S.A
Dental · 316d
Cleared Feb 27, 2015
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
K141123 · GWO
Alliance Partners, LLC
Neurology · 302d
Cleared Feb 27, 2015
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED...
K141183 · EFB
Ttbio Corp.
Dental · 296d
Cleared Feb 27, 2015
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto...
K141468 · OYE
Bd Biosciences
Immunology · 269d
Cleared Feb 27, 2015
V-GUIDE FOR VENTRICULOSTOMIES
K141559 · HAW
Arc Surgical, LLC
Neurology · 260d
Cleared Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
K141922 · NFJ
Intelligent Retinal Imaging Systems, LLC
Ophthalmic · 226d
Cleared Feb 27, 2015
PROCOTYL L-O ACETABULAR SYSTEM
K142119 · LPH
Microport Orthopedics, Inc.
Orthopedic · 207d
Cleared Feb 27, 2015
LIGHTMED TRUSCAN 577
K142172 · HQF
Lightmed Corp.
Ophthalmic · 204d
Cleared Feb 27, 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 157d
Cleared Feb 27, 2015
Single Use Biliary Balloon Dilator
K143303 · FGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 101d
Cleared Feb 27, 2015
Progressive Orthopaedic Total Hip System
K143314 · LPH
The Progressive Orthopaedic Company, LLC
Orthopedic · 100d
Cleared Feb 27, 2015
KATANA Zirconia
K143439 · EIH
Kuraray Noritake Dental, Inc.
Dental · 87d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
Cleared Feb 27, 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K150201 · DQY
Spectranetics, Inc.
Cardiovascular · 29d
Cleared Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · KIF
Dentsply International, Inc.
Dental · 202d
Cleared Feb 26, 2015
MAGNIFY and MAGNIFY-S Spacers
K142498 · OVD
Globus Medical, Inc.
Orthopedic · 174d
Cleared Feb 26, 2015
Spinal System
K142576 · NKB
Eisertech, LLC
Orthopedic · 167d