FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
121–144 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 02, 2025
Aura Wave
K250896 · SGT
Aura Wellness, LLC
Physical Medicine · 252d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058 · CGX
Truvian Health
Chemistry · 236d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694 · QAS
Mlhealth 360
Radiology · 263d
Cleared Nov 21, 2025
LEGACY
K252696 · HBG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
K250651 · SGR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 260d
Cleared Nov 14, 2025
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
K252618 · OHT
Alovea Healthcare Co. , Ltd.
General & Plastic Surgery · 87d
Cleared Nov 13, 2025
Dental Computed Tomography X-ray System
K251842 · OAS
Fussen Technology Co., Ltd.
Radiology · 150d
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