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

Filters: Cleared only ×
175,820 results
36697–36720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2014
INS HILDEN TIBIAL ARZZT
K133166 · HSB
Truemed Group, LLC
Orthopedic · 385d
Cleared Nov 06, 2014
NIOX VERO AIRWAY INFLAMMATION MONITOR
K133898 · MXA
Aerocrine AB
Chemistry · 321d
Cleared Nov 06, 2014
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10...
K140130 · OQG
Encore Medical, L.P.
Orthopedic · 293d
Cleared Nov 06, 2014
YONGHE
K140244 · LYZ
Yonghe Plastic Products Co., Ltd.
General Hospital · 280d
Cleared Nov 06, 2014
YONGFA
K140246 · LYZ
Yongfa Glove Co., Ltd.
General Hospital · 280d
Cleared Nov 06, 2014
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT...
K140355 · KGO
Terang Nusa Sdn Bhd
General Hospital · 267d
Cleared Nov 06, 2014
ZOLL E SERIES ALS
K140502 · LDD
ZOLL Medical Corporation
Cardiovascular · 252d
Cleared Nov 06, 2014
IG_PLEX CELIAC DGP PANEL
K140691 · MVM
Sqi Diagnostics Systems, Inc.
Immunology · 232d
Cleared Nov 06, 2014
CUTERA PICOSECOND LASER SYSTEM
K140727 · GEX
Cutera, Inc.
General & Plastic Surgery · 227d
Cleared Nov 06, 2014
STIMPOD ST2-3010 NERVE STIMULATOR
K140853 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 217d
Cleared Nov 06, 2014
ADVANTAGE
K141555 · GEX
Lutronic Corporation
General & Plastic Surgery · 147d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141668 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 136d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141674 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 136d
Cleared Nov 06, 2014
OBSIDIAN PRESS (ALL CERAMIC AND POM)
K141887 · EIH
Prismatik Dentalcraft, Inc.
Dental · 115d
Cleared Nov 06, 2014
NAKOMA ACP
K141993 · KWQ
Alliance Partners, LLC
Orthopedic · 107d
Cleared Nov 06, 2014
CAPRI
K142016 · MQP
K2m, Inc.
Orthopedic · 104d
Cleared Nov 06, 2014
LINK MP RECONSTRUCTION PROSTHESIS
K142187 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 90d
Cleared Nov 06, 2014
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial...
K142640 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 50d
Cleared Nov 06, 2014
FlexCath Select Steerable Sheath (10 French)
K142684 · DYB
Medtronic Cryocath, LP
Cardiovascular · 48d
Cleared Nov 05, 2014
ICE ZIRKON TRANSLUZENT
K132230 · EIH
Zirkonzahn Srl
Dental · 475d
Cleared Nov 05, 2014
GUIDOSS
K133507 · NPL
Nibec Co., Ltd.
Dental · 356d
Cleared Nov 05, 2014
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K133518 · KWQ
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 355d
Cleared Nov 05, 2014
SPEX SUPPORT CATHETER
K141649 · DQY
Reflow Medical
Cardiovascular · 138d
Cleared Nov 05, 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · NPL
Collagen Matrix, Inc.
Dental · 113d