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

5,276 results for "health"
1201–1224 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 07, 2019
DARI Health
K180880 · LXJ
Scientific Analytics, Inc.
Physical Medicine · 338d
Cleared Mar 06, 2019
Hearing Healthcare Pro
K183201 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 107d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Feb 28, 2019
Digital Thermometer
K182629 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 157d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Shanghai United Imaging Healthcare...
Radiology · 119d
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · JAD
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665 · MUJ
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Feb 21, 2019
Sensus IORT System
K182641 · JAD
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 15, 2019
IPL Hair Removal Device
K183217 · OHT
Touchbeauty Beauty & Health...
General & Plastic Surgery · 88d
Cleared Feb 14, 2019
Presero 3D Scanning System
K190074 · LLZ
Certis Health
General & Plastic Surgery · 29d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
K183291 · JAK
Hitachi Healthcare Americas
Radiology · 67d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jan 28, 2019
Aloka Arietta 850
K183456 · IYN
Hitachi Healthcare Americas
Radiology · 46d
Cleared Jan 24, 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · KPR
Prognosys Medical Systems Private...
Radiology · 35d
Cleared Jan 18, 2019
Pristina Serena 3D
K182951 · MUE
Ge Healthcare
Radiology · 87d
Cleared Jan 18, 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · OWQ
Innovative Health, LLC
Cardiovascular · 263d
Cleared Jan 17, 2019
DL Self-adhesive Electrode
K182111 · GXY
Shaoxing DL Healthcare Co., Ltd.
Neurology · 164d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · NUH
Omron Healthcare, Inc.
Neurology · 157d