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"
985–1008 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · PNR
Shinva Ande Healthcare Apparatus Co.,...
Gastroenterology & Urology · 257d
Cleared Sep 04, 2020
Ambra ProViewer
K202335 · LLZ
Dicom Grid Inc Dba Ambra Health
Radiology · 18d
Cleared Sep 04, 2020
SIGNA Artist
K202238 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 28d
Cleared Sep 03, 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · MTD
Innovative Health, LLC
Cardiovascular · 219d
Cleared Aug 28, 2020
DreaMed Advisor Pro
K201476 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 86d
Cleared Aug 28, 2020
Jada System
K201199 · OQY
Alydia Health
Obstetrics & Gynecology · 116d
Not Cleared Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
DEN190042 · QAX
Baxter Healthcare Corporation
Gastroenterology & Urology · 347d
Cleared Aug 26, 2020
Motex Anti-Fog Surgical Face Mask
K201549 · FXX
Modern Healthcare Corp.
General Hospital · 78d
Cleared Aug 17, 2020
3D Auto LAA
K201352 · LLZ
Philips Health Care
Radiology · 88d
Cleared Aug 13, 2020
Braid
K200822 · LLZ
Braid.Health
Radiology · 136d
Cleared Aug 13, 2020
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944 · PTA
Ancestry Genomics, Inc.
Hematology · 300d
Cleared Aug 11, 2020
ImagenSPECT 3.0
K201933 · KPS
Cardiovascular Imaging Technologies
Radiology · 29d
Cleared Aug 04, 2020
HYPER DLR
K193210 · KPS
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Aug 03, 2020
Glaucoma Module
K200954 · NFJ
Topcon Healthcare Solutions, Inc.
Ophthalmic · 116d
Cleared Aug 03, 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K200649 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 144d
Cleared Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · OMP
Cardinalhealth
General & Plastic Surgery · 463d
Cleared Jul 30, 2020
KY Grosz Jelly
K201186 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Jul 30, 2020
Reprocessed NRG Transseptal Needle
K200060 · QLZ
Innovative Health, LLC
Cardiovascular · 199d
Cleared Jul 29, 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN...
K200824 · FYA
Cardinal Health200, LLC
General Hospital · 121d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849 · LDD
Remote Diagnostic Technologies, Ltd....
Cardiovascular · 115d
Cleared Jul 22, 2020
Caption Interpretation Automated Ejection Fraction Software
K200621 · QIH
Caption Health
Radiology · 135d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jul 17, 2020
SCENARIA View
K200498 · JAK
Hitachi Healthcare Americas
Radiology · 140d