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
46057–46080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2011
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT...
K111345 · LPL
The See Clear Company, Inc.
Ophthalmic · 173d
Cleared Nov 02, 2011
BINGO PRO
K111474 · LQY
Forum Engineering Technologies (96) ,...
Dental · 159d
Cleared Nov 02, 2011
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · MMX
Cook, Inc.
Cardiovascular · 96d
Cleared Nov 02, 2011
REFLEX BALLON GUIDE CATHETER
K112262 · DQY
Reverse Medical Corporation
Cardiovascular · 86d
Cleared Nov 02, 2011
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
K112931 · NKB
Phygen, LLC
Orthopedic · 30d
Cleared Nov 02, 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 28d
Cleared Nov 02, 2011
NANO SUTURE ANCHOR
K112965 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 28d
Cleared Nov 02, 2011
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
K113036 · HEB
Kimberly Clark Corporation
Obstetrics & Gynecology · 21d
Cleared Nov 01, 2011
UC-CARE NAVIGO SYTEM
K100784 · LLZ
UC-CARE , Ltd.
Radiology · 592d
Cleared Nov 01, 2011
LCI OPTION FOR INNOCOR
K102047 · BZC
Innovision A/S
Anesthesiology · 468d
Cleared Nov 01, 2011
COOLTOUCH
K103338 · PDZ
New Star Lasers, Inc.
General & Plastic Surgery · 351d
Cleared Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
K110221 · LPN
Optics Laboratory, Inc.
Ophthalmic · 280d
Cleared Nov 01, 2011
EUS BALLOON
K111028 · FDF
United States Endoscopy Group, Inc.
Radiology · 202d
Cleared Nov 01, 2011
TRANSTEK
K112932 · MNW
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 01, 2011
BODY ANALYSIS SCALE
K112951 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 28d
Cleared Oct 31, 2011
FLIGHT 60 VENTILATOR
K111683 · CBK
Flight Medical Innovations , Ltd.
Anesthesiology · 138d
Cleared Oct 31, 2011
DISTAL VOLAR RADIUS PLATING SYSTEMS
K112345 · LXT
Medos International SARL
Orthopedic · 77d
Cleared Oct 31, 2011
CLO-SURPLUS P.A.D.
K112961 · QSY
Scion Cardio-Vascular, Inc.
General & Plastic Surgery · 27d
Cleared Oct 28, 2011
SUMO ACCESS AND TISSUE RESECTION SYSTEM
K103155 · ODC
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 367d
Cleared Oct 28, 2011
DUOCENTRIC REVERSED
K103251 · PHX
Aston Medical
Orthopedic · 359d
Cleared Oct 28, 2011
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278 · CGA
I-Sens, Inc.
Chemistry · 357d
Cleared Oct 28, 2011
MINI MASSEUSE
K110057 · NGX
Mj Specialty Retail
Physical Medicine · 291d
Cleared Oct 28, 2011
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
K110594 · CCK
Nihon Kohden Corp.
Anesthesiology · 240d
Cleared Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K111693 · MKJ
Philips Medical Systems
Cardiovascular · 134d