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"
289–312 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Visby Medical, Inc.
Microbiology · 177d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
AspenView
K241425 · LLZ
Aspen Imaging Healthcare, Inc.
Radiology · 268d
Cleared Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02,...
K243155 · FGB
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 134d
Cleared Feb 10, 2025
Philips Lumea IPL
K243453 · OHT
Philips Consumer Lifestyle B.V.
General & Plastic Surgery · 95d
Cleared Feb 03, 2025
iCare APP
K243146 · MWI
Ihealth Labs, Inc.
Cardiovascular · 126d
Cleared Feb 03, 2025
Sonicaid Team3
K241368 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 265d
Cleared Jan 27, 2025
Bunkerhill AVC
K243229 · JAK
BunkerHill Health
Radiology · 111d