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"
241–264 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 24, 2025
Sonu
K242214 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 269d
Cleared Apr 22, 2025
OcuMet Beacon (OCUB100)
K241931 · MYC
Ocusciences, Inc.
Ophthalmic · 295d
Cleared Apr 16, 2025
Clarius Prostate AI
K243853 · QIH
Clarius Mobile Health Corp.
Radiology · 121d
Cleared Apr 14, 2025
Merge Universal Viewer (MUV)
K250301 · LLZ
Merge Healthcare Incorporated
Radiology · 73d
Cleared Apr 11, 2025
Disposable ureteral access sheath
K243710 · FED
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 130d
Cleared Apr 11, 2025
FUJIFILM Processor EP-8000
K243260 · FET
Fujifilm Corporation
Gastroenterology & Urology · 178d
Cleared Apr 08, 2025
BunkerHill BMD
K242295 · KGI
BunkerHill Health
Radiology · 249d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 01, 2025
MR Contour DL
K242925 · QKB
Ge Healthcare
Radiology · 189d
Cleared Mar 28, 2025
INNOVANCE Antithrombin
K242952 · JBQ
Siemens Healthcare Diagnostic...
Hematology · 184d
Not Cleared Mar 28, 2025
Visby Medical Women's Sexual Health Test
DEN240020 · SEA
Visby Medical, Inc.
Microbiology · 319d
Cleared Mar 27, 2025
AI-Rad Companion Organs RT
K242745 · QKB
Siemens Healthcare GmbH
Radiology · 197d
Cleared Mar 26, 2025
Electrically powered wheelchair
K244003 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 90d
Cleared Mar 19, 2025
PeekMed web
K250042 · QIH
Peek Health, S.A.
Radiology · 70d
Cleared Mar 18, 2025
CarbonCool® System
K240933 · NZE
Global Healthcare SG Sdn. Bhd
Cardiovascular · 347d
Cleared Mar 17, 2025
Air Compression Leg Massager (K-705)
K242140 · IRP
Jiale Health Technology Shenzhen Co.,...
Physical Medicine · 238d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Mar 11, 2025
8mm Monopolar Curved Scissors (470179)
K242610 · QSM
Iconocare Health
General & Plastic Surgery · 189d
Cleared Mar 07, 2025
EpiWatch Monitoring System
K243515 · POS
Epiwatch, Inc.
Neurology · 114d
Cleared Mar 05, 2025
Prostate MR AI (VA10A)
K241770 · QDQ
Siemens Healthcare GmbH
Radiology · 258d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Feb 28, 2025
Durex Polyisoprene Condom
K241617 · MOL
Rb Health (Us), LLC
Obstetrics & Gynecology · 268d
Cleared Feb 24, 2025
ExamVue Apex
K244010 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 60d
Cleared Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use...
K243959 · LZC
Lingshi Hongruida Health Protection...
General Hospital · 63d