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"
337–360 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 06, 2024
PeekMed web
K240926 · LLZ
Peek Health, S.A.
Radiology · 246d
Cleared Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
K242685 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 89d
Cleared Nov 29, 2024
Evie Med Ring
K241090 · DQA
Movano Inc. Dba Movano Health
Anesthesiology · 221d
Cleared Nov 27, 2024
Sonix Health
K240645 · QIH
Ontact Health Co., Ltd.
Radiology · 265d
Cleared Nov 22, 2024
Jasmate® Toothpaste
K242913 · LBH
Jasberry Healthcare Private Limited
Dental · 59d
Cleared Nov 22, 2024
Cala kIQ
K242259 · QBC
Cala Health, Inc.
Neurology · 114d
Cleared Nov 21, 2024
PliaFX Flo
K242799 · MBP
Lifenet Health
Orthopedic · 65d
Cleared Nov 21, 2024
SKR 3000
K241319 · MQB
Konica Minolta, Inc.
Radiology · 195d
Cleared Nov 18, 2024
CT Collaboration Live
K242329 · LLZ
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Nov 18, 2024
Saige-Dx
K241747 · QDQ
DeepHealth, Inc.
Radiology · 153d
Cleared Nov 15, 2024
1CMR Pro
K242062 · LLZ
Mycardium AI Limited
Radiology · 123d
Cleared Nov 14, 2024
Besmed Bacterial Filter and HMEF
K241339 · CAH
Besmed Health Business Corp
General Hospital · 185d
Cleared Nov 12, 2024
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 82d
Cleared Nov 12, 2024
Change Healthcare Stratus Imaging PACS
K241981 · LLZ
Change Healthcare Canada Company
Radiology · 130d
Cleared Nov 07, 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · MQB
Aspen Imaging Healthcare, Inc.
Radiology · 178d
Cleared Nov 01, 2024
Over-tube (TR-1108A)
K243091 · FED
Fujifilm Corporation
Gastroenterology & Urology · 32d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622 · QRK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 55d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 17, 2024
Electrically powered wheelchair (HP202)
K241337 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 157d
Cleared Oct 16, 2024
Electrically powered wheelchair
K241632 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 132d
Cleared Oct 11, 2024
Hood (DH-083ST)
K242779 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 11, 2024
PPH Saliva Collection Kit
K240797 · QBD
Permantis Public Health
Microbiology · 203d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d