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"
1369–1392 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 18, 2017
Optum TeleHealth Application
K171406 · DRG
United Health Group, Inc.
Cardiovascular · 98d
Cleared Aug 17, 2017
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K171028 · CCK
GE Healthcare Finland Oy
Anesthesiology · 134d
Cleared Aug 16, 2017
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
K172162 · IYN
Siemens Healthcare
Radiology · 29d
Cleared Aug 11, 2017
ADVIA 2120i, ADVIA 2120
K162977 · GKZ
Siemens Healthcare Diagnostics
Hematology · 289d
Cleared Aug 10, 2017
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models...
K171116 · MSH
3M Healthcare
General Hospital · 118d
Cleared Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 103d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d
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 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