FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
29689–29712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
K161954 · JGS
Siemens Healthcare Diagnostics
Chemistry · 234d
Cleared Mar 09, 2017
Hoggan Scientific® microFET2™
K162412 · LBB
Hoggan Scientific, LLC
Neurology · 192d
Cleared Mar 09, 2017
PhotoFix Decellularized Bovine Pericardium
K162506 · DXZ
Cryolife, Inc.
Cardiovascular · 182d
Cleared Mar 09, 2017
FLEX Microwave Ablation System and Accessories
K163118 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 121d
Cleared Mar 09, 2017
JAZZ SOLO Sensor
K163224 · MUH
Jazz Imaging, LLC
Radiology · 113d
Cleared Mar 09, 2017
3.3 mm Laurimed Microdebrider
K163247 · ERL
Laurimed, LLC
Ear, Nose, Throat · 111d
Cleared Mar 09, 2017
ARTIS pheno
K163286 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 107d
Cleared Mar 09, 2017
SeaSpine® Daytona® Small Stature Spinal System
K163604 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 78d
Cleared Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · JFM
Siemens Healthcare Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 09, 2017
Level One Hand Plating System
K170124 · HRS
KLS-Martin L.P.
Orthopedic · 55d
Cleared Mar 09, 2017
NuVasive® Reline® 4.5-5.0 System
K170126 · NKB
Nu Vasive, Incorporated
Orthopedic · 55d
Cleared Mar 09, 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · NBW
Apex BioTechnology Corp.
Chemistry · 41d
Cleared Mar 09, 2017
ANSiStim-PP
K170391 · BWK
Dyansys, Inc.
Neurology · 29d
Cleared Mar 09, 2017
Sterispine™ PS
K170528 · NKB
Safe Orthopaedics
Orthopedic · 15d
Cleared Mar 08, 2017
Solitaire Platinum Revascularization Device, 6x40 mm
K160641 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 366d
Cleared Mar 08, 2017
Nipro SafeTouch IV Catheter
K161681 · FOZ
Nipro Medical Corporation
General Hospital · 264d
Cleared Mar 08, 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 258d
Cleared Mar 08, 2017
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with...
K161898 · FPA
Beijing Fert Technology Co., Ltd.
General Hospital · 240d
Cleared Mar 08, 2017
CRC-77tHR
K162394 · KPT
Capintec, Inc.
Radiology · 194d
Cleared Mar 08, 2017
Q2 Low Pressure Power Injection Extension Set
K162804 · FPA
Quest Medical, Inc.
General Hospital · 154d
Cleared Mar 08, 2017
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing...
K162890 · DZE
Straumann USA, LLC
Dental · 142d
Cleared Mar 08, 2017
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
K163054 · DXT
Osprey Medical, Inc.
Cardiovascular · 127d
Cleared Mar 08, 2017
Expro Elite Snare, Sympro Elite Snare
K163307 · MMX
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Mar 08, 2017
Rampart(TM) T Lumbar Interbody Fusion Device
K163409 · MAX
Spineology, Inc.
Orthopedic · 93d