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"
1417–1440 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Jul 28, 2017
Wheelchair
K163352 · IOR
Kunshan Hi-Fortune Health Products...
Physical Medicine · 240d
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jul 19, 2017
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
K171093 · LZA
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 98d
Cleared Jul 14, 2017
Dictum Health
K170798 · MWI
Dictum Health, Inc.
Cardiovascular · 119d
Cleared Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · OWQ
Innovative Health, LLC
Cardiovascular · 205d
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
K170587 · JIN
ACON Laboratories, Inc.
Chemistry · 128d
Cleared Jul 03, 2017
Enterprise Imaging XERO Viewer 8.1
K170434 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Jun 23, 2017
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
K162582 · HIF
Fisher & Paykel Healthcare
Obstetrics & Gynecology · 281d
Cleared Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K170922 · NLH
Innovative Health, LLC
Cardiovascular · 85d
Cleared Jun 21, 2017
DRX-Revolution Nano Mobile X-ray System
K170755 · IZL
Carestream Health, Inc.
Radiology · 100d
Cleared Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · FPA
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Jun 16, 2017
Silhouette InstaLift
K163676 · GAM
Silhouette Lift, Inc.
General & Plastic Surgery · 171d
Cleared Jun 15, 2017
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves,...
K170198 · KGO
Cardinal Health, Inc.
General Hospital · 143d
Cleared Jun 13, 2017
HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and...
K163079 · ILY
Healthlight, LLC
Physical Medicine · 222d
Cleared Jun 09, 2017
Cardinal Health Non-Reinforced Surgical Gown
K170762 · FYA
Cardinal Health200, LLC
General Hospital · 88d
Cleared Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
K170311 · PNE
Innovative Health, LLC
Cardiovascular · 121d
Cleared Jun 01, 2017
syngo Dynamics Version VA30
K171053 · LLZ
Siemens Healthcare GmbH
Radiology · 52d
Cleared May 31, 2017
Infusion Set for Single Use
K162601 · FPA
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 254d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
Cleared May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 151d
Cleared May 12, 2017
N Latex Cystatin C
K171072 · NDY
Siemens Healthcare Diagnostics...
Chemistry · 32d
Cleared May 12, 2017
Unity Network ID
K170199 · MWI
Ge Healthcare
Cardiovascular · 109d