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
38401–38424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2014
ANYPLUS
K131612 · MAX
GS Medical Co., Ltd.
Orthopedic · 319d
Cleared Apr 18, 2014
PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND...
K132075 · MHX
Mindray North America
Cardiovascular · 289d
Cleared Apr 18, 2014
ERGONOMIC PRODUCTS WORKSTATION
K132315 · EIA
Ergonomic Products, Inc.
Dental · 267d
Cleared Apr 18, 2014
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
K132406 · NBW
Infopia Co, Ltd.
Chemistry · 259d
Cleared Apr 18, 2014
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
K132679 · CAH
Galemed Corp.
General Hospital · 233d
Cleared Apr 18, 2014
P-POD
K133397 · MVA
P-Pod
Neurology · 163d
Cleared Apr 18, 2014
MCKESSON CARDIOLOGY ECG MOBILE
K133534 · DQK
Mckesson Israel , Ltd.
Cardiovascular · 151d
Cleared Apr 18, 2014
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO...
K133597 · JOH
Cook, Inc.
Anesthesiology · 147d
Cleared Apr 18, 2014
COMPASS CT, COMPASS CT PORT
K133624 · DRS
Mirador Biomedical
Cardiovascular · 143d
Cleared Apr 18, 2014
GALAXY CO2 LASER SYSTEM
K133915 · GEX
Beijing Toplaser Technology Co., Ltd.
General & Plastic Surgery · 116d
Cleared Apr 18, 2014
GENTLECARE AR APPLICATOR
K133922 · JAQ
Gc Medtech, LLC
Radiology · 116d
Cleared Apr 18, 2014
MITEK ARTHROSCOPES
K133941 · HRX
Medos International SARL
Orthopedic · 116d
Cleared Apr 18, 2014
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998 · PNO
Angioscore, Inc.
Cardiovascular · 113d
Cleared Apr 18, 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 18, 2014
JULIET OL
K140474 · MAX
Spineart
Orthopedic · 52d
Cleared Apr 18, 2014
ORTHOSORB LS
K140625 · OVZ
Biomet, Inc.
Orthopedic · 38d
Cleared Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · CFR
Beckman Coulter, Inc.
Chemistry · 356d
Cleared Apr 17, 2014
SMART (SMART-D, SMART-DX)
K131660 · LXJ
Bts S.P.A.
Physical Medicine · 315d
Cleared Apr 17, 2014
HC-1 AND HC-1 CLASSIC
K131852 · KPL
Transcendencias Comerciales SL Transcom
Gastroenterology & Urology · 300d
Cleared Apr 17, 2014
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
K131962 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 294d
Cleared Apr 17, 2014
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K132547 · NDC
Monarch Medical Technologies
General Hospital · 247d
Cleared Apr 17, 2014
ICONN ANSWER SUTURE ANCHOR
K132724 · MBI
Iconn Orthopedics, LLC
Orthopedic · 230d
Cleared Apr 17, 2014
FLIP INTRODUCER ACCESS KIT
K132789 · DYB
Vascular Solutions, Inc.
Cardiovascular · 223d
Cleared Apr 17, 2014
ADVATX
K132976 · GEX
Advalight Aps
General & Plastic Surgery · 206d