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"
1225–1248 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Nov 09, 2018
Heat Pain Pro
K181992 · NUH
Omron Healthcare, Inc.
Neurology · 106d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 07, 2018
uWS-CT
K173001 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 07, 2018
uWS-MR
K172999 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · OWB
Ge Healthcare
Radiology · 157d
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d