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

5,274 results for "health"
217–240 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 05, 2025
iPETcertum (v1.0)
K244016 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 221d
Cleared Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Aug 01, 2025
AK 98 Dialysis Machine (955607)
K250508 · KDI
Vantive US Healthcare, LLC
Gastroenterology & Urology · 161d
Cleared Jul 29, 2025
PRORAD ATLAS ULTRAPORTABLE
K243473 · IZL
Prognosys Medical Systems Private...
Radiology · 263d
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033 · FMF
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared Jul 22, 2025
Granudacyn® Wound Irrigation Solution
K243415 · FRO
P.G.F. Industry Solutions GmbH
General & Plastic Surgery · 263d
Cleared Jul 18, 2025
Profoject™ Enteral Feeding Syringe
K251585 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 56d
Cleared Jul 17, 2025
uMI Panvivo (uMI Panvivo)
K251839 · KPS
Shanghai United Imaging Healthcare...
Radiology · 31d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 16, 2025
uMR 680
K243397 · LNH
Shanghai United Imaging Healthcare...
Radiology · 258d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917 · BZR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Jul 09, 2025
EZ-FIDUCIALS
K250505 · HAW
Phasor Health, LLC
Neurology · 138d
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · LJE
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 135d
Cleared Jul 02, 2025
Power Wheelchair (MOB1107)
K250729 · ITI
Vive Health, LLC
Physical Medicine · 113d
Cleared Jul 02, 2025
Compressor Nebulizer (NB-1100)
K243468 · CAF
Joytech Healthcare Co. , Ltd.
Anesthesiology · 236d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 26, 2025
Freedom® Total Knee System – Titanium Tibial Base Plate
K251717 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 22d
Cleared Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 121d
Cleared Jun 25, 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 29d