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

Filters: 2026–2026 ×
1,922 results
1849–1872 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 12, 2026
Boston iFace (Boston iFace)
K251988 · GEI
Boston Aesthetics, Inc.
General & Plastic Surgery · 199d
Cleared Jan 12, 2026
EmpowerRide NAVIGATOR
K251886 · IOR
Empower Ride, LLC
Physical Medicine · 206d
Cleared Jan 12, 2026
Star E900 Electric System
K251701 · EBW
Dentalez, Inc., Stardental Division
Dental · 224d
Cleared Jan 12, 2026
Precision AI Surgical Planning System (PAI-SPS)
K251558 · QHE
Precision AI Pty, Ltd.
Orthopedic · 236d
Cleared Jan 12, 2026
Dr. Yglo Skin Tag Remover
K251524 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 241d
Cleared Jan 12, 2026
High speed air turbine handpiece
K251389 · EFB
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Jan 12, 2026
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS,...
K251388 · EFB
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Jan 12, 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 259d
Cleared Jan 12, 2026
SBC1 Cream
K250890 · FRO
Sioxmed, LLC
General & Plastic Surgery · 293d
Cleared Jan 11, 2026
SafeOp 3: Neural Informatix System
K252842 · GWF
Alphatec Spine, Inc.
Neurology · 125d
Cleared Jan 09, 2026
JARVIS Metaphyseal Stem
K254003 · PHX
FH Industrie
Orthopedic · 25d
Cleared Jan 09, 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · EIH
Liaoning Upcera Co., Ltd.
Dental · 29d
Cleared Jan 09, 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 29d
Cleared Jan 09, 2026
HemosIL Silica Clotting Time
K253957 · GFO
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Jan 09, 2026
Self-Forming Magnet (Flexagon Plus OTOLoc)
K253550 · SAH
GI Windows, Inc.
General & Plastic Surgery · 56d
Cleared Jan 09, 2026
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
K253142 · DXN
Ningbo Ranor Medical Technology Co.,...
Cardiovascular · 106d
Cleared Jan 09, 2026
Mobility scooter (Air Classic)
K253075 · INI
Suzhou Sweetrich Vehicle Industry...
Physical Medicine · 108d
Cleared Jan 09, 2026
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
K252906 · OXC
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 119d
Cleared Jan 09, 2026
NextAR Hip Platform
K252847 · SBF
Medacta International S.A.
Orthopedic · 123d
Cleared Jan 09, 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · DQX
Solo Pace, Inc.
Cardiovascular · 137d
Cleared Jan 09, 2026
Corvair Monza
K252589 · MHX
AliveCor, Inc.
Cardiovascular · 147d
Cleared Jan 09, 2026
iotaSOFT® Insertion System
K252339 · QQH
Iotamotion, Inc.
Ear, Nose, Throat · 165d
Cleared Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · CGX
Nova Biomedical Corporation
Chemistry · 179d
Cleared Jan 09, 2026
Core Metabolic
K251157 · CIX
Truvian Health
Chemistry · 269d