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
73–96 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d
Cleared Jun 18, 2026
Precice™ Max System and Precice™ Ankle Salvage System
K261651 · HSB
NuVasive Specialized Orthopedics
Orthopedic · 30d
Cleared Jun 18, 2026
SRGC-06
K261246 · EBF
GC America, Inc.
Dental · 63d
Cleared Jun 18, 2026
Blood Volume Analyzer (200)
K261099 · JWO
Daxor Corporation
Hematology · 77d
Cleared Jun 18, 2026
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
K260946 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Jun 18, 2026
VIVIX-S 4386W (FXRD-4386WA)
K260820 · MQB
Vieworks Co., Ltd.
Radiology · 97d
Cleared Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729 · QAS
GuideAI Health
Radiology · 104d
Cleared Jun 18, 2026
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
K260636 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 112d
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