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"
433–456 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 20, 2023
uOmnispace.MI
K233176 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 83d
Cleared Dec 19, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · FLE
Primus Sterilizer Company, LLC
General Hospital · 83d
Cleared Dec 15, 2023
Videa Dental Assist
K232384 · MYN
Videahealth, Inc.
Radiology · 129d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Dec 14, 2023
MedHealth DVT compression Devices MHH900S/MHH900E
K231801 · JOW
Medhealth Medical Limited
Cardiovascular · 177d
Cleared Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · CFN
Siemens Healthcare Diagnostics...
Immunology · 28d
Cleared Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · ITX
Fujifilm Healthcare Americas Corporation
Radiology · 189d
Cleared Dec 05, 2023
Aurelia Surgical Mask ASTM Level 1
K231005 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 242d
Not Cleared Dec 04, 2023
Sonu
DEN230045 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 171d
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