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
361–384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2026
Powder Free Nitrile Examination Gloves Non-Sterile Black
K253824 · LZA
Kanglongda Vietnam Protection...
General Hospital · 199d
Cleared Jun 18, 2026
Power Wheelchair (W5915B, W5915C, W5915D)
K253812 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 202d
Cleared Jun 18, 2026
Implantmed Plus II & Piezomed Plus II Module
K253776 · DZI
W&H Dentalwerk Buermoos GmbH
Dental · 204d
Cleared Jun 18, 2026
MAMMOMAT B.brilliant (11372950)
K253678 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 209d
Cleared Jun 18, 2026
ECMT-100 WMD
K253521 · KGN
Ecm Therapeutics, Inc.
General & Plastic Surgery · 217d
Cleared Jun 18, 2026
SteriBest® Sterilization Tray System
K253187 · KCT
Mastel Surgical
General Hospital · 265d
Cleared Jun 18, 2026
Curing Light (M-Cure 6)
K253131 · EBZ
Guangzhou Rebornendo Medical...
Dental · 266d
Cleared Jun 18, 2026
Wrist Blood Pressure Monitor (XW-05)
K253126 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 266d
Cleared Jun 18, 2026
3D MAC Titanium Cranial Plate (TCP) System
K253116 · GXN
The Surgeon General, Department of...
Neurology · 267d
Cleared Jun 18, 2026
Sol-Glide Safety Needle
K253110 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared Jun 18, 2026
AND Medical Femoral Nail System (PFNA01)
K253080 · HSB
Suzhou and Science & Technology...
Orthopedic · 268d
Cleared Jun 18, 2026
Portable DR Imaging System
K253058 · IZL
Shantou Institute of Ultrasonic...
Radiology · 269d
Cleared Jun 18, 2026
RadOncAI
K253050 · MUJ
Informai
Radiology · 269d
Cleared Jun 18, 2026
CONDUIT™ ZERO-P™ VA Secured Spacer System
K252982 · OVE
Avalign Technologies, Inc.
Orthopedic · 274d
Cleared Jun 18, 2026
ZywieZ3 Sensor & Adhesive
K252839 · MWJ
Zywie, Inc.
Cardiovascular · 286d
Cleared Jun 18, 2026
inspired™ Heated Breathing Circuit (510-008)
K252066 · BZE
Vincent Healthcare Products Limited
Anesthesiology · 352d
Cleared Jun 18, 2026
InstaTRU Instant Biological Indicator for Steam (IBI-05)
K251559 · QVB
True Indicating, LLC
General Hospital · 393d
Cleared Jun 18, 2026
MegaGen Zygoma Dental Implant System
K251232 · DZE
Megagen Implant Co., Ltd.
Dental · 422d
Cleared Jun 18, 2026
Dental Implant System
K250806 · DZE
A.B. Dental Devices , Ltd.
Dental · 458d
Cleared Jun 17, 2026
twiist Automated Insulin Delivery (AID) System
K261672 · QFG
Deka Research and Development
Chemistry · 27d
Cleared Jun 17, 2026
Bonvadis®
K261638 · FRO
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 30d
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Jun 17, 2026
PICOSURE WORKSTATION
K261570 · GEX
Cynosure, LLC
General & Plastic Surgery · 36d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d