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"
145–168 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d
Cleared Oct 03, 2025
Bunkerhill MAC
K250662 · JAK
BunkerHill Health
Radiology · 212d
Cleared Oct 03, 2025
HPACS
K250039 · LLZ
Healthhub
Radiology · 268d
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Visby Medical, Inc.
Microbiology · 139d
Cleared Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594 · HRX
Sonex Health
Orthopedic · 45d
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 161d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Sep 22, 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · JSM
Jinan Babio Biotechnology Co., Ltd.
Microbiology · 241d
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 19, 2025
Videa Dental AI
K251002 · MYN
Videahealth, Inc.
Radiology · 171d
Cleared Sep 19, 2025
Sonicaid Team3
K250777 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 189d
Cleared Sep 19, 2025
Bunkerhill ECG-EF
K250649 · QYE
BunkerHill Health
Cardiovascular · 199d
Cleared Sep 17, 2025
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
K251623 · IRP
Shenzhen Yicai Health Technology Co.,...
Physical Medicine · 112d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Sep 11, 2025
Vivatmo pro-S
K243926 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 265d
Cleared Sep 10, 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb...
K252173 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 61d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Sep 09, 2025
Electric Wheelchair (GY-E001)
K251891 · ITI
Shandong Guyue Healthcare Appliance...
Physical Medicine · 81d
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Aug 29, 2025
GLAM LED Facial Mask (TB-2386F)
K251727 · GEX
Touchbeauty Beauty & Health...
General & Plastic Surgery · 85d
Cleared Aug 27, 2025
Vital Signs
K243687 · QME
Oxehealth Limited
Cardiovascular · 271d