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"
313–336 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 27, 2025
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · KPS
Raysolution Healthcare Co., Ltd.
Radiology · 266d
Cleared Jan 23, 2025
MONARCH™ Platform (MON-000008)
K243219 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 22, 2025
Suture-TOOL System
K242835 · NEW
Suturion AB
General & Plastic Surgery · 125d
Cleared Jan 22, 2025
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3,...
K241956 · FGB
Hunan Endoso Life Technology Co., Ltd.
Gastroenterology & Urology · 203d
Cleared Jan 16, 2025
Cala kIQ
K243848 · QBC
Cala Health, Inc.
Neurology · 31d
Cleared Jan 15, 2025
Cardiac Guidance
K243065 · QJU
Caption Health, Inc.
Radiology · 110d
Cleared Jan 14, 2025
uCT 550
K241166 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 13, 2025
Sterilized Eol Auto Lancet
K243533 · FMK
Hlb Co., Ltd. Healthcare
General & Plastic Surgery · 59d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842 · MSX
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
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