FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
30409–30432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Dec 09, 2016
truSculpt
K162512 · PBX
Cutera, Inc.
General & Plastic Surgery · 92d
Cleared Dec 09, 2016
BD Pen Needle
K162516 · FMI
Becton, Dickinson and Company
General Hospital · 91d
Cleared Dec 09, 2016
Jewel Precision Reusable Rigid Sterilization Container System
K162600 · KCT
Jewel Precision Sheet Metal &...
General Hospital · 81d
Cleared Dec 09, 2016
16ch T/R Hand Wrist Coil
K162623 · MOS
Quality Electrodynamics, LLC
Radiology · 80d
Cleared Dec 09, 2016
EnFocus 2300, EnFocus 4400
K162783 · OBO
Bioptigen, Inc.
Ophthalmic · 67d
Cleared Dec 09, 2016
Medline UNITE® Ankle Fracture Plating System
K162829 · HRS
Medline Industries, Inc.
Orthopedic · 63d
Cleared Dec 09, 2016
Contact Lens Case
K162869 · LRX
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Ophthalmic · 57d
Cleared Dec 09, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K162974 · HRS
Biomet Microfixation
Orthopedic · 45d
Cleared Dec 09, 2016
Traxcess 7 Mini XSoft Guidewire
K163154 · MOF
MicroVention, Inc.
Neurology · 29d
Cleared Dec 08, 2016
Worker Guidewire
K160785 · DQX
Argon Medical Devices, Inc.
Cardiovascular · 261d
Cleared Dec 08, 2016
ImagingRing System
K161400 · IYE
Medphoton GmbH
Radiology · 202d
Cleared Dec 08, 2016
ESTETICA Dental Treatment Unit and Accessories
K161488 · EIA
Kaltenbach & Voigt GmbH
Dental · 190d
Cleared Dec 08, 2016
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
K161632 · GEX
Bios S.R.L.
General & Plastic Surgery · 178d
Cleared Dec 08, 2016
Wireless Digital Flat Panel Detector
K161730 · MQB
Iray Technology (Shanghai) , Ltd.
Radiology · 168d
Cleared Dec 08, 2016
Stryker Universal Mesh
K161821 · GWO
Stryker
Neurology · 160d
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Innovative Health, LLC
Cardiovascular · 156d
Cleared Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005 · HQD
Acuity Polymers, Inc.
Ophthalmic · 141d
Cleared Dec 08, 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · KWQ
Medicrea International SA
Orthopedic · 125d
Cleared Dec 08, 2016
ProNova SC360 Proton Therapy System
K162246 · LHN
Pronova Solutions, LLC
Radiology · 120d
Cleared Dec 08, 2016
CAAS MR 4D Flow
K162376 · LLZ
Pie Medical Imaging BV
Radiology · 106d
Cleared Dec 08, 2016
Proture Double Electric Breast Pump
K162747 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 69d
Cleared Dec 08, 2016
VIPER PRIME™ additions to the VIPER® System
K162912 · NKB
Medos International SARL
Orthopedic · 52d
Cleared Dec 08, 2016
DC-UIBC-CAL
K163078 · JIT
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 35d
Cleared Dec 07, 2016
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · DHR
The Binding Site Group , Ltd.
Immunology · 329d