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

5,198 results for "health"
1417–1440 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d
Cleared Feb 14, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · DXN
Andon Health Co, Ltd.
Cardiovascular · 141d
Cleared Feb 10, 2017
LOGIQ P9 and LOGIQ P7
K163596 · IYN
Ge Healthcare
Radiology · 51d
Cleared Feb 08, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · DXN
Andon Health Co, Ltd.
Cardiovascular · 114d
Cleared Feb 07, 2017
PUREtrace™
K153262 · OSP
Nemo Healthcare BV
Obstetrics & Gynecology · 455d
Cleared Feb 02, 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · DYB
Medtronic Cryocath, LP
Cardiovascular · 73d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Jan 31, 2017
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with...
K162381 · LZA
Healthy Glove Co., Ltd.
General Hospital · 160d
Cleared Jan 24, 2017
F&P InfoSmart
K161686 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 221d
Cleared Jan 23, 2017
Lifestyles Zero Lubricated Latex Male Condom
K163107 · HIS
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 77d
Cleared Jan 19, 2017
Atellica CH Magnesium (Mg)
K162399 · JGJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 146d
Cleared Jan 19, 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation...
K161418 · OMP
Cardinalhealth
General & Plastic Surgery · 241d
Cleared Jan 18, 2017
F&P Brevida™ Nasal Pillows Mask
K161412 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 243d
Cleared Jan 17, 2017
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A...
K162663 · GZJ
Well-Life Healthcare Limited
Neurology · 113d
Cleared Jan 12, 2017
48CH Head Coil
K163205 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 58d
Cleared Jan 06, 2017
PrismaSATE
K162887 · KPO
Baxter Healthcare Corporation
Gastroenterology & Urology · 81d
Cleared Jan 04, 2017
DigitalDiagnost C50
K163410 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 30d
Cleared Dec 26, 2016
Sysmex CS-2100i
K162688 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · NLH
Innovative Health, LLC
Cardiovascular · 133d