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
28393–28416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2017
27HJ713S
K170899 · GCJ
Lg Electronics
General & Plastic Surgery · 64d
Cleared May 30, 2017
Portable ECG Monitor
K170954 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 60d
Cleared May 30, 2017
gammaCore-S
K171306 · PKR
Electrocore, LLC
Neurology · 27d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
Cleared May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing...
K162448 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared May 26, 2017
Creatine Kinase-MB
K162526 · JHW
Roche Diagnostics
Chemistry · 259d
Cleared May 26, 2017
Masimo O3 Regional Oximeter System
K162603 · MUD
Masimo Corporation
Cardiovascular · 249d
Cleared May 26, 2017
T3 Software
K163065 · MWI
Etiometry, Inc.
Cardiovascular · 205d
Cleared May 26, 2017
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
K163140 · OWB
Gemss Medical Systems Co., Ltd.
Radiology · 198d
Cleared May 26, 2017
MIS V3 Conical Connection Dental Implant System­
K163349 · DZE
Mis Implants Technologies , Ltd.
Dental · 178d
Cleared May 26, 2017
AcceleDent Optima
K170093 · OYH
Orthoaccel Technology, Inc.
Dental · 135d
Cleared May 26, 2017
FFR V2.5
K170133 · IYO
Philips Volcano
Radiology · 129d
Cleared May 26, 2017
Ultravision Visual Field Clearing System
K170178 · PQM
Alesi Surgical, Ltd.
General Hospital · 127d
Cleared May 26, 2017
Flexitouch System
K170216 · JOW
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 122d
Cleared May 26, 2017
IQ Technologies
K170659 · NUH
Iq Technologies, Inc.
Neurology · 84d
Cleared May 26, 2017
Respire Pink Series with DentiTrac
K170692 · LRK
Respire Medical Holding
Dental · 80d
Cleared May 26, 2017
RAPID Web
K170839 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 66d
Cleared May 26, 2017
Nova StatSensor Creatinine Hospital Meter System
K171059 · CGL
Nova Biomedical Corporation
Chemistry · 46d
Cleared May 26, 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217 · DXT
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared May 26, 2017
DELL UP3017 with QUBYX PerfectLum bundle
K171229 · PGY
Qubyx Software Technologies, Inc.
Radiology · 29d
Cleared May 26, 2017
My Dose Coach
K171230 · NDC
Sanofi
General Hospital · 29d
Cleared May 26, 2017
Mistral-Air Warming Unit
K171234 · DWJ
The Surgical Company International BV...
Cardiovascular · 29d
Cleared May 26, 2017
da Vinci X Surgical System
K171294 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 24d
Cleared May 26, 2017
SutureTape
K171296 · GAT
Arthrex, Inc.
General & Plastic Surgery · 24d