FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36097–36120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2014
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K140732 · GEX
Candela Corp.
General & Plastic Surgery · 228d
Cleared Nov 07, 2014
INNOVASIS CRANIAL SYSTEM
K141644 · GWO
Innovasis, Inc.
Neurology · 141d
Cleared Nov 07, 2014
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K141771 · NYI
Nanostring Technologies, Inc.
Pathology · 129d
Cleared Nov 07, 2014
MIDLINE II TI
K141942 · OVD
Centinel Spine, Inc.
Orthopedic · 113d
Cleared Nov 07, 2014
PUREFILL OXYGEN COMPRESSOR
K141967 · CAW
Inovo, Inc.
Anesthesiology · 109d
Cleared Nov 07, 2014
ENCORE HUMERAL SHOULDER STEM
K141990 · PHX
Encore Medical, L.P.
Orthopedic · 108d
Cleared Nov 07, 2014
SMR 40MM GLENOSPHERE
K142139 · PHX
Lima Corporate S.P.A.
Orthopedic · 94d
Cleared Nov 07, 2014
Power Twin21-50/Power Twin21-100
K142215 · ILY
Livetec GmbH
Physical Medicine · 87d
Cleared Nov 07, 2014
EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
K142550 · JWH
Microport Orthopedics, Inc.
Orthopedic · 58d
Cleared Nov 07, 2014
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
K143001 · FRO
Argentum Medical
General & Plastic Surgery · 21d
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