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: Cleared only ×
175,230 results
4849–4872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2025
Arthrex DynaNite Nitinol Staples
K243742 · JDR
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 65d
Cleared Jan 31, 2025
Game Ready system (550500-04)
K243572 · IRP
Avanos Medical, Inc.
Physical Medicine · 74d
Cleared Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243441 · LZA
Basic Medical Technology, Inc.
General Hospital · 86d
Cleared Jan 31, 2025
Nuance Audio Hearing Aid Software
K243150 · SCR
Luxottica Group S.P.A.
Ear, Nose, Throat · 123d
Cleared Jan 31, 2025
Mobility Scooter (MS160A)
K242982 · INI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 127d
Cleared Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · DQO
Gentuity, LLC
Cardiovascular · 127d
Cleared Jan 31, 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K242442 · HWC
Innovate Orthopaedics, Ltd.
Orthopedic · 168d
Cleared Jan 31, 2025
Synthgene Home Test HCG Test Strip
K242135 · LCX
Nanjing Synthgene Medical Technology...
Chemistry · 193d
Cleared Jan 31, 2025
ZeTTA PACS
K241694 · LLZ
Tae Young Soft Co., Ltd.
Radiology · 233d
Cleared Jan 31, 2025
SwimCount® Harvester (1 mL)
K241348 · MQK
Motilitycount Aps
Obstetrics & Gynecology · 263d
Cleared Jan 31, 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel...
K241334 · LDF
C.R. Bard, Inc.
Cardiovascular · 266d
Cleared Jan 31, 2025
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K241193 · JFB
Marzzan Lucas Jorge
Physical Medicine · 277d
Cleared Jan 30, 2025
Osprey Suture Anchor
K243726 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 58d
Cleared Jan 30, 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · MBI
Abanza Tecnomed S.L
Orthopedic · 59d
Cleared Jan 30, 2025
iBOT® PMD
K243442 · IMK
Mobius Mobility
Physical Medicine · 85d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Jan 30, 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · NBW
Guangdong Transtek Medical...
Chemistry · 125d
Cleared Jan 30, 2025
Ureteral Access Sheath
K243025 · FED
Seplou (Zhuhai) Co., Ltd.
Gastroenterology & Urology · 125d
Cleared Jan 30, 2025
Rotarex Atherectomy System
K242757 · MCW
Bard Peripheral Vascular, Inc.
Cardiovascular · 140d
Cleared Jan 30, 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K242717 · BTT
Laboratorios Biogalenic S.A. DE C.V.
Anesthesiology · 142d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 30, 2025
MyShoulder Planner (5.3SSWPL)
K241292 · KWS
Medacta International S.A.
Orthopedic · 267d