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"
1177–1200 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jan 03, 2019
uCT 520, uCT 528
K183143 · JAK
Shangai United Imaging Healthcare...
Radiology · 51d
Cleared Jan 02, 2019
ClearUP Sinus Pain Relief
K182025 · GZJ
Tivic Health Systems, Inc.
Neurology · 156d
Cleared Dec 21, 2018
3nethra neo
K183059 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 20, 2018
AirSpiral Heated Breathing Tube
K162553 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 828d
Cleared Dec 18, 2018
Emission Computed Tomography System
K182938 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Dec 14, 2018
Centricity Universal Viewer
K182419 · LLZ
Ge Healthcare
Radiology · 100d
Cleared Dec 11, 2018
Cardinal Health Sterilization Wrap
K181174 · FRG
Cardinal Health200, LLC
General Hospital · 223d
Cleared Dec 06, 2018
Unity Network ID
K183116 · MWI
Ge Healthcare
Cardiovascular · 27d
Cleared Dec 06, 2018
IntelliSpace Radiology
K182926 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 45d
Cleared Nov 30, 2018
FerriSmart Analysis System
K182218 · PCS
Resonance Health Analysis Services...
Radiology · 107d
Cleared Nov 16, 2018
SmartBag (SmartPouch)
K181643 · EXB
11 Health Technologies Limited
Gastroenterology & Urology · 147d
Cleared Nov 16, 2018
Oral Device OA, Oral Device S
K181396 · LRK
Passion For Life Healthcare (Uk) Limited
Dental · 171d
Cleared Nov 15, 2018
Voluson E6, Voluson E8, Voluson E10
K181985 · IYN
Ge Healthcare
Radiology · 113d
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Innovative Health, LLC
Cardiovascular · 122d
Cleared Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
K182481 · DXN
Omron Healthcare, Inc.
Cardiovascular · 60d