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"
1081–1104 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 22, 2020
E-EEGX, N-EEGX
K191322 · OLT
GE Healthcare Finland Oy
Neurology · 252d
Cleared Jan 21, 2020
CARESCAPE B650
K191149 · MHX
GE Healthcare Finland Oy
Cardiovascular · 266d
Cleared Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
K193493 · DGC
Siemens Healthcare Diagnostics, Inc.
Immunology · 29d
Cleared Jan 15, 2020
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU...
K193225 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 54d
Cleared Jan 09, 2020
Altapore
K192363 · MQV
Baxter Healthcare Corporation
Orthopedic · 132d
Cleared Jan 08, 2020
EASYGRIP FLO-41 Precision MIS Delivery System
K193137 · GCJ
Baxter Healthcare Corportation
General & Plastic Surgery · 56d
Cleared Jan 03, 2020
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K193239 · LRK
Mpowrx Health and Wellness Products...
Dental · 39d
Not Cleared Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
DEN180067 · QIS
Diversatek Healthcare, Inc.
Gastroenterology & Urology · 371d
Cleared Dec 21, 2019
Spinalytics
K192629 · LXM
Optima Health Solutions International...
Neurology · 89d
Cleared Dec 20, 2019
SX-One MicroKnife
K192873 · LXH
Sonex Health, Inc.
Orthopedic · 73d
Cleared Dec 20, 2019
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · KPR
Carestream Health, Inc.
Radiology · 158d
Cleared Dec 20, 2019
QLAB Advanced Quantification Software
K191647 · QIH
Philips Health Care
Radiology · 183d
Cleared Dec 20, 2019
Carescape One
K190008 · MHX
Ge Healthcare
Cardiovascular · 352d
Cleared Dec 19, 2019
uMC 560i
K183144 · OWB
Shanghai United Imaging Healthcare...
Radiology · 401d
Cleared Dec 18, 2019
Sterile Latex Powder-Free Surgical Gloves
K191898 · KGO
Modern Healthcare Corp.
General Hospital · 155d
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