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"
481–504 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 01, 2023
Syngo Carbon Clinicals
K232856 · QIH
Siemens Healthcare GmbH
Radiology · 77d
Cleared Nov 29, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with...
K231482 · JAK
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Nov 28, 2023
Cue COVID-19 Molecular Test
K232643 · QWB
Cue Health, Inc.
Microbiology · 90d
Cleared Nov 28, 2023
Monarch Bronchoscope
K231473 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 190d
Cleared Nov 27, 2023
CardioPhase® hsCRP
K232624 · DCN
Siemens Healthcare Diagnostic...
Immunology · 90d
Cleared Nov 20, 2023
Harmony
K232555 · NFJ
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared Nov 20, 2023
ARIETTA x10
K231941 · IYN
Fujifilm Healthcare Americas Corporation
Radiology · 143d
Cleared Nov 16, 2023
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
K233200 · OWB
GEMSS HEALTHCARE CO., LTD.
Radiology · 49d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,...
K232241 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
Microwave Ablation System (BD-GT)
K232240 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 08, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · MBI
Healthium Medtech Limited
Orthopedic · 51d
Cleared Nov 06, 2023
Revital Cady
K231519 · FMF
Revital Healthcare (Epz) Limited
General Hospital · 165d
Cleared Nov 02, 2023
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F...
K230800 · KPR
GEMSS HEALTHCARE CO., LTD.
Radiology · 224d
Cleared Oct 30, 2023
Empatica Health Monitoring Platform
K230457 · MWI
Empatica S.R.L.
Cardiovascular · 251d
Cleared Oct 27, 2023
Digital Expert Access with Remote Scanning
K232346 · LNH
Ge Healthcare
Radiology · 84d
Cleared Oct 27, 2023
Cold/Hot Compression
K223541 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 336d
Cleared Oct 24, 2023
Aco Apache Ultrasound System
K231509 · IYN
Aco Healthcare Co., Ltd.
Radiology · 152d
Cleared Oct 20, 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · KGO
Ansell Healthcare
General Hospital · 114d
Cleared Oct 20, 2023
Sonix Health
K230209 · QIH
Ontact Health Co., Ltd.
Radiology · 268d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 16, 2023
ANDORATE® Valve Kit
K232118 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 91d
Cleared Oct 16, 2023
Iontophoresis Electrodes
K232020 · EGJ
Top-Rank Health Care Co., Ltd.
Physical Medicine · 101d
Cleared Oct 12, 2023
Scenaria View 4.2
K231574 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 134d