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"
961–984 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
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