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
361–384 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 18, 2026
NOVEOS Specific IgE (sIgE)
K260280 · DHB
Hycor Biomedical
Immunology · 140d
Cleared Jun 18, 2026
ARTHUR
K260190 · IYO
ROPCA ApS
Radiology · 147d
Cleared Jun 18, 2026
Pelvic Muscle Trainer (KM510, KM516B)
K260178 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 148d
Cleared Jun 18, 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 171d
Cleared Jun 18, 2026
SmartSpectra Vital Signs Monitor 1.0
K254169 · QME
Presage Security, Inc. d/b/a Presage...
Cardiovascular · 177d
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