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"
169–192 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 06, 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · NGX
Motive Health, Inc.
Physical Medicine · 23d
Cleared Nov 05, 2025
EVAC-MRI
K252514 · JXG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 04, 2025
Tamburo Thulium Fiber Laser System
K251303 · GEX
Menovex Medical Technology (Shenzhen)...
General & Plastic Surgery · 190d
Cleared Oct 31, 2025
GREEN
K252060 · HBE
Phasor Health, LLC
Neurology · 122d
Cleared Oct 30, 2025
AiORTA - Plan
K250337 · QIH
ViTAA Medical Solutions, Inc.
Radiology · 266d
Cleared Oct 29, 2025
Freedom Infinia™ Total Knee System
K253314 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 29d
Cleared Oct 27, 2025
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
K252053 · OHS
Touchbeauty Beauty & Health...
General & Plastic Surgery · 118d
Cleared Oct 24, 2025
Cryon-X Cold Compression
K253150 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 29d
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 22, 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 27d
Cleared Oct 21, 2025
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 29d
Cleared Oct 20, 2025
VereSee Optical Veres Needle and Endoscopic Camera
K252640 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 60d
Cleared Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 262d
Cleared Oct 16, 2025
Profoject™ Disposable Needle
K252631 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d
Cleared Oct 03, 2025
Bunkerhill MAC
K250662 · JAK
BunkerHill Health
Radiology · 212d
Cleared Oct 03, 2025
HPACS
K250039 · LLZ
Healthhub
Radiology · 268d
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Visby Medical, Inc.
Microbiology · 139d
Cleared Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594 · HRX
Sonex Health
Orthopedic · 45d
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 161d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Sep 22, 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · JSM
Jinan Babio Biotechnology Co., Ltd.
Microbiology · 241d