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"
289–312 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 20, 2024
iHealth® Early Pregnancy Test
K241394 · LCX
Andon Health Co, Ltd.
Chemistry · 218d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Saige-Dx (3.1.0)
K243688 · QDQ
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · PNR
Cardinalhealth
Gastroenterology & Urology · 23d
Cleared Dec 19, 2024
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
K241322 · HGX
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 223d
Cleared Dec 17, 2024
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
K242987 · GEX
Allengers Global Healthcare Private...
General & Plastic Surgery · 82d
Cleared Dec 13, 2024
Laminar P1 (LDH-HW-001)
K242487 · JAF
Laminar Digital Health, Inc.
Cardiovascular · 114d
Cleared Dec 12, 2024
uMI Panvivo (uMI Panvivo)
K243538 · KPS
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Dec 10, 2024
DRX-Revolution Mobile X-ray System
K241505 · IZL
Carestream Health, Inc.
Radiology · 196d
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