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

5,277 results for "health"
1441–1464 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared May 11, 2017
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
K161961 · LYY
Ug Global Resources Sdn. Bhd.
General Hospital · 297d
Cleared May 04, 2017
Nucleus Image Management System
K171130 · LLZ
Nucleushealth, LLC
Radiology · 17d
Cleared May 03, 2017
PrisMax Control Unit
K163530 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 138d
Cleared Apr 28, 2017
RFID Localization System- Localizer Reader, RFID Localization System-...
K163667 · PBY
Health Beacons, Inc.
General & Plastic Surgery · 122d
Cleared Apr 28, 2017
BabyDance Fertility Lubricant
K162319 · PEB
Fairhaven Health, LLC
Obstetrics & Gynecology · 252d
Cleared Apr 21, 2017
syngo.CT Cardiac Planning
K170221 · JAK
Siemens Healthcare GmbH
Radiology · 86d
Cleared Apr 21, 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
K162930 · FYA
Halyard Health, Inc.
General Hospital · 184d
Cleared Apr 20, 2017
HEM-9210T
K163235 · DXN
Omron Healthcare, Inc.
Cardiovascular · 154d
Cleared Apr 20, 2017
Cardinal Health Sterilization Wrap
K161910 · FRG
Cardinal Health200, LLC
General Hospital · 282d
Cleared Apr 14, 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K162517 · NUH
Jkh Health Co., Ltd.
Neurology · 217d
Cleared Apr 13, 2017
Coolief* Cooled RF Probe
K163461 · GXI
Halyard Health, Inc.
Neurology · 125d
Cleared Apr 13, 2017
Intelli-Ox
K161179 · ECX
Air Liquide Healthcare America...
Anesthesiology · 352d
Cleared Apr 11, 2017
Carestream Vue PACS
K170580 · LLZ
Carestream Health, Inc.
Radiology · 42d
Cleared Apr 11, 2017
LOGIQ S8
K170445 · IYN
Ge Healthcare
Radiology · 56d
Cleared Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
K163220 · LCM
Siemens Healthcare Diagnostics, Inc.
Toxicology · 141d
Not Cleared Apr 06, 2017
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary...
DEN160026 · PTA
23AndMe, Inc.
Hematology · 282d
Cleared Mar 21, 2017
SmartGrid
K163157 · MQB
Carestream Health
Radiology · 131d
Cleared Mar 17, 2017
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K163586 · PIF
Trovrx, Inc. Dba Trovita Health Science
Gastroenterology & Urology · 87d
Cleared Mar 17, 2017
Exam Vue PACS
K162868 · LLZ
Jpi Healthcare Solutions, Inc.
Radiology · 155d
Cleared Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG
Siemens Healthcare Diagnostics
Chemistry · 212d
Cleared Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · JFM
Siemens Healthcare Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
K161954 · JGS
Siemens Healthcare Diagnostics
Chemistry · 234d
Cleared Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
K163045 · DXN
Omron Healthcare, Inc.
Cardiovascular · 113d