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
5305–5328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033 · QJP
Penumbra, Inc.
Neurology · 153d
Cleared Dec 11, 2024
OsseoFit Stemless Shoulder System
K241873 · PKC
Zimmer, Inc.
Orthopedic · 167d
Cleared Dec 11, 2024
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker...
K241219 · OWX
ZuriMED Technologies AG
Orthopedic · 224d
Cleared Dec 11, 2024
EndoTool IV (3.1)
K241088 · NDC
Monarch Medical Technologies
Chemistry · 236d
Cleared Dec 11, 2024
Disposable Subdermal Needle Electrode, Corkscrew
K241045 · GXZ
Technomed Europe
Neurology · 238d
Cleared Dec 11, 2024
Radiofrequency Generator System, Cura RF Electrode
K240758 · GEI
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 266d
Cleared Dec 10, 2024
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
K243216 · MWI
Analog Devices
Cardiovascular · 68d
Cleared Dec 10, 2024
Digital Color Doppler Ultrasound Imaging System (Readius L15)
K243132 · IYN
Shantou Institute of Ultrasonic...
Radiology · 71d
Cleared Dec 10, 2024
Philips IntelliSite Pathology Solution 5.1
K242848 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 81d
Cleared Dec 10, 2024
Aerin Console
K242630 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 98d
Cleared Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
K242511 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared Dec 10, 2024
Empulse M90
K242327 · ITI
Concourse Assistive Technology Pty, Ltd.
Physical Medicine · 126d
Cleared Dec 10, 2024
Elos Accurate® Hybrid Base™
K242025 · NHA
Elos Medtech Pinol A/S
Dental · 152d
Cleared Dec 10, 2024
Prelude Small O.D. Introducer Guide Wire
K241521 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 195d
Cleared Dec 10, 2024
DRX-Revolution Mobile X-ray System
K241505 · IZL
Carestream Health, Inc.
Radiology · 196d
Cleared Dec 10, 2024
Straumann® PURE Ceramic Implants
K241391 · DZE
Institut Straumann AG
Dental · 209d
Cleared Dec 10, 2024
POTENZA
K231216 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 592d
Cleared Dec 09, 2024
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · HSB
Smith & Nephew, Inc.
Orthopedic · 41d
Cleared Dec 09, 2024
Atrauman® Ag
K242758 · FRO
Hartmann USA, Inc.
General & Plastic Surgery · 88d
Cleared Dec 09, 2024
AutoContour (Model RADAC V4)
K242729 · QKB
Radformation, Inc.
Radiology · 90d
Cleared Dec 09, 2024
Verily Numetric Retinal Camera
K242508 · HKI
Verily Life Sciences, LLC
Ophthalmic · 109d
Cleared Dec 09, 2024
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
K242451 · DYG
Edwards Lifesciences
Cardiovascular · 115d
Cleared Dec 09, 2024
Digital Radiography System (ManntiX B, ManntiX K)
K240841 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 257d