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
3265–3288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · MUD
Vioptix, Inc.
General & Plastic Surgery · 125d
Cleared Jun 26, 2025
Neuralytix iD3 System (NTX-9001)
K243636 · PDQ
Neuralytix, LLC
Neurology · 213d
Cleared Jun 26, 2025
AISight Dx
K243391 · QKQ
PathAI, Inc.
Pathology · 238d
Cleared Jun 26, 2025
Equinoxe® Scapula Fracture System
K243275 · HRS
Exactech, Inc.
Orthopedic · 253d
Cleared Jun 26, 2025
Sterilization Pouch and Roll
K243179 · FRG
Yichang Xinxin Paper Products Co., Ltd.
General Hospital · 269d
Cleared Jun 26, 2025
Disposable Intermittent Catheter (TPU Catheter)
K243175 · EZD
Chengdu Daxan Innovative Medical...
Gastroenterology & Urology · 269d
Cleared Jun 26, 2025
NeuroTrac® MyoPlus Pro (MYO120U)
K243079 · KPI
Verity Medical , Ltd.
Gastroenterology & Urology · 269d
Cleared Jun 26, 2025
Doppler FHR Detector (BF-500D+, BF-560)
K242846 · KNG
Shenzhen Bestman Instrument Co., Ltd.
Obstetrics & Gynecology · 279d
Cleared Jun 25, 2025
ANAX™ OCT Spinal System
K251725 · NKG
Cg Medtech Co., Ltd.
Orthopedic · 20d
Cleared Jun 25, 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)
K251627 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 25, 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 29d
Cleared Jun 25, 2025
Power Wheelchair (D26)
K251606 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 29d
Cleared Jun 25, 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
K251371 · GKZ
Sysmex America, Inc.
Hematology · 54d
Cleared Jun 25, 2025
X-PAC® LLIF Expandable Lateral Cage System
K251003 · MAX
Expanding Innovations, Inc.
Orthopedic · 85d
Cleared Jun 25, 2025
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
K250966 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 86d
Cleared Jun 25, 2025
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
K250943 · GKZ
Sysmex America, Inc.
Hematology · 89d
Cleared Jun 25, 2025
CORIOGRAPH Pre-Op Planning and Modeling Services
K250921 · PBF
Blue Belt Technologies, Inc.
Orthopedic · 90d
Cleared Jun 25, 2025
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
K250774 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 103d
Cleared Jun 25, 2025
Globe® Pulsed Field System
K250747 · DQK
Kardium, Inc.
Cardiovascular · 105d
Cleared Jun 25, 2025
GeniPhys Collymer Self-Assembling Scaffold
K250329 · KGN
Geniphys, Inc.
General & Plastic Surgery · 140d
Cleared Jun 25, 2025
Flexible Partial Resin
K250302 · EBI
Prismatik Dentalcraft, Inc.
Dental · 142d
Cleared Jun 25, 2025
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
K243184 · DQY
Strait Access Technologies Holdings
Cardiovascular · 268d
Cleared Jun 25, 2025
Curapuls 670
K243112 · IMJ
Enraf-Nonius, B.V.
Physical Medicine · 268d
Cleared Jun 25, 2025
EGIS Biliary Double Bare Stent (BDB080405)
K242845 · FGE
S&G Biotech, Inc.
Gastroenterology & Urology · 278d