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"
913–936 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 15, 2021
IMMULITE® 2000 Cortisol
K202826 · CGR
Siemens Healthcare Diagnostics...
Toxicology · 113d
Cleared Jan 12, 2021
Disposable Medical Surgical Mask
K201625 · FXX
Tianjin Saiyuan Technology Co., Ltd.
General Hospital · 211d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Dec 30, 2020
JianYu Surgical Mask
K201754 · FXX
Jiangsu Jianyu Health Medical Co., Ltd.
General Hospital · 184d
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073 · PTA
Helix Opco, LLC
Immunology · 509d
Cleared Dec 10, 2020
AquaPulse Irrigation Tubing
K202560 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 97d
Cleared Dec 07, 2020
HepaFat-AI
K201039 · LNH
Resonance Health Analysis Services...
Radiology · 231d
Cleared Dec 04, 2020
Nucleus.io
K203249 · LLZ
Nucleushealth, LLC
Radiology · 30d
Cleared Dec 04, 2020
HealthJOINT
K202487 · LLZ
Zebra Medical Vision, Ltd.
Radiology · 95d
Cleared Dec 03, 2020
AireHealth NebulizerTM
K201167 · CAF
Airehealth, Inc.
Anesthesiology · 216d
Cleared Dec 02, 2020
Lux 35 Detector
K203159 · MQB
Carestream Health
Radiology · 40d
Cleared Nov 30, 2020
Avenda Health Treatment System
K201687 · GEX
Avenda Health, Inc.
General & Plastic Surgery · 161d
Cleared Nov 25, 2020
CPR Face Shield
K192285 · CBP
Firstar Healthcare Company Limited...
Anesthesiology · 461d
Cleared Nov 22, 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...
K202090 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 117d
Cleared Nov 20, 2020
Revolution Ascend
K203169 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Nov 20, 2020
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
K201867 · FKX
Baxter Healthcare Corporation
Gastroenterology & Urology · 135d
Cleared Nov 18, 2020
TrueView 100 Pro
K202713 · MWP
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology · 63d
Cleared Nov 13, 2020
SIGNA Architect
K202966 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 44d
Cleared Nov 06, 2020
Durex Penck Standard, Durex Penck XL
K200672 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 238d
Cleared Nov 04, 2020
Arietta 65
K202422 · IYN
Hitachi Healthcare Americas
Radiology · 72d
Cleared Oct 22, 2020
Voluson E10
K201768 · IYN
Ge Healthcare
Radiology · 115d
Cleared Oct 21, 2020
OASIS MRI System
K202030 · LNH
Hitachi Healthcare Americas
Radiology · 91d