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"
937–960 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 16, 2020
Disposable Vinyl Glove
K202010 · LYZ
Better Health Medical Products Co., Ltd.
General Hospital · 87d
Cleared Oct 16, 2020
Finetest Lite Smart Blood Glucose Monitoring System
K201396 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 141d
Cleared Oct 07, 2020
Livocare Surgical Mask
K201380 · FXX
Andon Health Co, Ltd.
General Hospital · 134d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · JOY
Scopio Labs , Ltd.
Hematology · 140d
Cleared Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL
Andon Health Co, Ltd.
General Hospital · 197d
Cleared Sep 27, 2020
Portable Mesh Nebulizer
K182906 · CAF
Feellife Health, Inc.
Anesthesiology · 711d
Cleared Sep 25, 2020
Xeleris V Processing and Review Systems
K201103 · LLZ
Ge Healthcare
Radiology · 154d
Cleared Sep 25, 2020
Breezing Med
K200076 · BZL
Tf Health Co.
Anesthesiology · 255d
Cleared Sep 18, 2020
Caption Guidance
K201992 · QJU
Caption Health
Radiology · 63d
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