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
39169–39192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2013
AUTOLITH TOUCH
K130368 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 274d
Cleared Nov 15, 2013
ND NABIL DIB INFUSION CATHETER
K130569 · KRA
Translational Research Institute
Cardiovascular · 256d
Cleared Nov 15, 2013
SYMPHONY RF GENERATOR
K130689 · GEI
Thermigen, Inc.
General & Plastic Surgery · 247d
Cleared Nov 15, 2013
NEOVEIL
K130997 · OXC
Gunze Limited
General & Plastic Surgery · 219d
Cleared Nov 15, 2013
MICROCYN SCAR MANAGEMENT HYDROGEL
K131672 · PFP
Oculus Innovative Sciences
General & Plastic Surgery · 162d
Cleared Nov 15, 2013
TENSYN BAND
K131850 · HTN
Dallen Medical, Inc.
Orthopedic · 147d
Cleared Nov 15, 2013
ELECTRONIC PULSE STIMULATOR
K131921 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 142d
Cleared Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA...
K132376 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Nov 15, 2013
TRANSGATE GUIDE CATHETER
K132542 · DQY
Stryker Neurovascular
Cardiovascular · 94d
Cleared Nov 15, 2013
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K132741 · OMP
Kci USA, Inc.
General & Plastic Surgery · 73d
Cleared Nov 15, 2013
MAGNETOM AERA
K132951 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Nov 15, 2013
SHARPSOLOGY 2
K133031 · MMK
Industrial Water Solutions, Inc.
General Hospital · 50d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · GQG
Becton, Dickinson & CO
Microbiology · 29d
Cleared Nov 15, 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION...
K133142 · IYO
Volcano Corporation
Radiology · 29d
Cleared Nov 14, 2013
IQ IMPLANTS
K130829 · DZE
Iq Implants , Ltd.
Dental · 233d
Cleared Nov 14, 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · DXN
Robert Bosch Healthcare Systems, Inc.
Cardiovascular · 216d
Cleared Nov 14, 2013
ANKER DENTAL IMPLANT SYSTEM
K131165 · DZE
Alliance Global
Dental · 204d
Cleared Nov 14, 2013
DIGITAL ELECTROCARDIOGRAPHS
K131262 · DPS
Sonoscape Company Limited
Cardiovascular · 195d
Cleared Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
K131284 · NAK
Wallac OY
Chemistry · 192d
Cleared Nov 14, 2013
MERIDIAN
K131753 · EBF
Ab Ardent
Dental · 153d
Cleared Nov 14, 2013
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 150d
Cleared Nov 14, 2013
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
K132527 · IYN
Sonoscape Company Limited
Radiology · 94d
Cleared Nov 14, 2013
DOSIMETRY CHECK VERSION 4 RELEASE 1
K132605 · IYE
Math Resolutions, LLC
Radiology · 86d