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

5,275 results for "health"
529–552 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 24, 2023
Current Health System
K231506 · MSX
Current Health , Ltd.
Cardiovascular · 92d
Cleared Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610 · FYA
Dongguan Shin YI Healthcare Products...
General Hospital · 170d
Cleared Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
K230079 · KGO
Ansell Healthcare Products, LLC
General Hospital · 225d
Cleared Aug 18, 2023
Holmium Medical Laser
K231718 · GEX
Allengers Global Healthcare Private...
General & Plastic Surgery · 66d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 16, 2023
Kyphoplasty Balloon Catheter
K223709 · HRX
Jiangsu Changmei Medtech Co., Ltd.
Orthopedic · 247d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443 · BZG
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Aug 04, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button,...
K231404 · MBI
Healthium Medtech Limited
Orthopedic · 81d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 01, 2023
Protego Air Water Connector
K231602 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 61d
Cleared Aug 01, 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy...
K230162 · JAK
Shanghai United Imaging Healthcare...
Radiology · 193d
Cleared Jul 27, 2023
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...
K230838 · FYA
Cardinal Health200, LLC
General Hospital · 122d
Cleared Jul 26, 2023
uMI Panorama
K231572 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 25, 2023
Emit® II Plus Buprenorphine Assay
K221605 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 418d
Cleared Jul 20, 2023
uOmnispace
K230039 · QIH
Shanghai United Imaging Healthcare...
Radiology · 195d
Cleared Jul 19, 2023
syngo.CT Lung CAD (Version VD30)
K231157 · OEB
Siemens Healthcare GmbH
Radiology · 86d
Cleared Jul 14, 2023
JiveX (Model Number / Release: 5.4)
K231041 · LLZ
Visus Health IT GmbH
Radiology · 93d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426 · LNH
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra...
K222116 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 360d