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
2665–2688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2025
Apollo TMS Therapy System
K243700 · OBP
Mag & More GmbH
Neurology · 279d
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Arterys, Inc.
Radiology · 22d
Cleared Sep 03, 2025
Kinos Total Ankle System
K252454 · HSN
Restor3d
Orthopedic · 30d
Cleared Sep 03, 2025
BruxZir® NOW
K252446 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Sep 03, 2025
AquaCast Mask
K252174 · IYE
Blessing Cathay Corporation
Radiology · 54d
Cleared Sep 03, 2025
NeurotriS (SX2500)
K251909 · NFO
A-1 Engineering
Neurology · 75d
Cleared Sep 03, 2025
SignalNED System (Model RE)
K251726 · OMC
Forest Devices, Inc.
Neurology · 90d
Cleared Sep 03, 2025
IdentiTi™ II ALIF Standalone Interbody System
K251575 · OVD
Alphatec Spine
Orthopedic · 104d
Cleared Sep 03, 2025
Diode laser therapy device (VADER)
K251457 · GEX
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 114d
Cleared Sep 03, 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · DXQ
Avita Corporation
Cardiovascular · 174d
Cleared Sep 03, 2025
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X,...
K250231 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 219d
Cleared Sep 03, 2025
AGNES Ultra
K250217 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 222d
Cleared Sep 03, 2025
MEDILIGHT
K231952 · ONF
Medicreations, LLC
General & Plastic Surgery · 796d
Cleared Sep 02, 2025
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
K251975 · NJD
Ignite Orthomotion
Orthopedic · 68d
Cleared Sep 02, 2025
RODIN Cement
K251775 · EMA
Belport Company, Inc., Gingi-Pak
Dental · 84d
Cleared Sep 02, 2025
Aerogen Pro-X1 Controller System
K251615 · SFP
Aerogen, Ltd.
Anesthesiology · 98d
Cleared Sep 02, 2025
OsteoSight™ Hip (v1)
K251408 · SAO
Naitive Technologies, Ltd.
Radiology · 119d
Cleared Sep 02, 2025
VELMENI for DENTISTS (V4D)
K250753 · MYN
Velmeni, Inc.
Radiology · 174d
Cleared Sep 02, 2025
IntelliVue Patient Monitor 6100 (6100)
K250453 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 196d
Cleared Sep 02, 2025
Customized Abutment and Screw
K242768 · NHA
Chengdu Besmile Medical Technology...
Dental · 354d
Cleared Aug 29, 2025
Millipede70 Aspiration Catheter
K252392 · NRY
Perfuze, Ltd.
Neurology · 29d
Cleared Aug 29, 2025
Invisalign System
K252380 · NXC
Align Technology, Inc.
Dental · 30d
Cleared Aug 29, 2025
Edwards eSheath Optima introducer set
K252364 · DYB
Edwards Lifesciences
Cardiovascular · 31d
Cleared Aug 29, 2025
CurvaFix Low Profile System
K252019 · HWC
Curvafix, Inc.
Orthopedic · 60d