FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2521–2544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2025
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10)
K251689 · ELC
Nakanishi, Inc.
Dental · 109d
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 19, 2025
IPGTFL-02
K251100 · GEX
Ipg Medical Corporation
Gastroenterology & Urology · 162d
Cleared Sep 19, 2025
Videa Dental AI
K251002 · MYN
Videahealth, Inc.
Radiology · 171d
Cleared Sep 19, 2025
EQUIA LC ONE
K250953 · EMA
GC America, Inc.
Dental · 175d
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 19, 2025
Coated hip implants
K250450 · LZO
Medacta International S.A.
Orthopedic · 213d
Cleared Sep 19, 2025
Alegria Flash ENA Screen
K250408 · LLL
Zeus Scientific
Immunology · 218d
Cleared Sep 19, 2025
Single Use Suction-Evacuation Ureteral Access Sheath
K250128 · FED
Anhui Happiness Workshop Medical...
Gastroenterology & Urology · 245d
Cleared Sep 19, 2025
Portable mesh nebulizer (JM821)
K244035 · CAF
Shenzhen Jermei Medical Device...
Anesthesiology · 263d
Cleared Sep 19, 2025
BondEase 2 Topical Skin Adhesive
K243990 · MPN
Optmed, Inc.
General & Plastic Surgery · 267d
Cleared Sep 19, 2025
Purema H Hemoconcentrator - Pediatric
K243920 · KDI
Medica USA, Inc.
Gastroenterology & Urology · 273d
Cleared Sep 19, 2025
VEGA
K242859 · GEX
Ibramed Equipamentos M?dicos
General & Plastic Surgery · 364d
Cleared Sep 19, 2025
xR IVD
K241868 · PZM
Tempus AI, Inc.
Pathology · 449d
Cleared Sep 18, 2025
Electric Wheelchair (Model P2)
K252428 · ITI
Superpi Robot Co., Ltd.
Physical Medicine · 48d
Cleared Sep 18, 2025
Normatec Elite Hip
K251905 · IRP
NormaTec Industries, LP
Physical Medicine · 90d
Cleared Sep 18, 2025
Sunny Plus (Sunny)
K251649 · NFO
ShenB Co., Ltd.
Neurology · 112d
Cleared Sep 18, 2025
InnerView System
K251597 · EKX
Perimetrics, Inc.
Dental · 114d
Cleared Sep 18, 2025
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody...
K251479 · MAX
Mobarn Medical Devices, LLC
Orthopedic · 128d
Cleared Sep 18, 2025
Magic InBra
K251377 · HGX
Medela AG
Obstetrics & Gynecology · 139d
Cleared Sep 18, 2025
ULTRASONIC PROBE UM-3R (UM-3R)
K250883 · ITX
Olympus Medical Systems Corporation
Radiology · 178d
Cleared Sep 18, 2025
Axial3D Insight
K250369 · QIH
Axial Medical Printing Limited
Radiology · 220d
Cleared Sep 17, 2025
Ruthless Spine RJB
K252615 · QWL
Ruthless, LLC Dba Ruthless Spine
Orthopedic · 29d