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"
1057–1080 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Dec 13, 2019
Satisfaite
K190752 · NUC
Femmepharma Consumer Healthcare, LLC
Obstetrics & Gynecology · 263d
Cleared Dec 12, 2019
Health Expert Electronic Stimulator
K190673 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 272d
Cleared Dec 11, 2019
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
K191880 · DRF
Innovative Health, LLC
Cardiovascular · 149d
Cleared Dec 10, 2019
Health Line CT CVC
K192533 · FOZ
Health Line International Corporation
General Hospital · 85d
Cleared Dec 04, 2019
VenaPro Vascular Therapy System
K193020 · JOW
Innovamed Health, LLC
Cardiovascular · 35d
Cleared Dec 02, 2019
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · FXX
Cardinal Health200, LLC
General Hospital · 94d
Cleared Nov 26, 2019
HealthCXR
K192320 · QFM
Zebra Medical Vision, Ltd.
Radiology · 92d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Nov 22, 2019
LEva Pelvic Digital Health System
K192270 · HIR
Renovia, Inc.
Obstetrics & Gynecology · 92d
Cleared Nov 21, 2019
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839 · LFD
Oralabs, Inc.
Dental · 498d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Nov 19, 2019
RSI-MRI+
K191278 · LLZ
Multimodal Imaging Services...
Radiology · 190d
Cleared Nov 18, 2019
Digital Thermometer
K183393 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 09, 2019
Omics Core
K190661 · PZM
Nanthealth, Inc.
Pathology · 240d
Cleared Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · PIF
Cardinalhealth
Gastroenterology & Urology · 212d
Cleared Nov 04, 2019
DRX-Evolution/Plus with Dual Energy
K190330 · KPR
Carestream Health, Inc.
Radiology · 263d
Cleared Nov 01, 2019
COPAL exchange G Hip and Knee Spacers
K191016 · KWY
Heraeus Medical GmbH
Orthopedic · 198d
Cleared Nov 01, 2019
Foryou NPWT Dressing Kit
K190119 · OMP
4l Health Co., Ltd.
General & Plastic Surgery · 281d
Cleared Oct 31, 2019
Claritag
K190747 · GEH
Dgi Technologies
General & Plastic Surgery · 223d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
K192705 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 28d