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
27673–27696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2017
NuVasive® Modulus TLIF Interbody System
K172341 · MAX
Nu Vasive, Incorporated
Orthopedic · 85d
Cleared Oct 26, 2017
SILC® Fixation System
K172417 · OWI
Globus Medical, Inc.
Orthopedic · 77d
Cleared Oct 26, 2017
EPI K Console
K172994 · HNO
Moria SA
Ophthalmic · 29d
Cleared Oct 26, 2017
SeaSpine Ventura NanoMetalene System
K173022 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Oct 26, 2017
Cocoon Portable Handheld X-Ray System
K173046 · MUH
Dexcowin Co., Ltd.
Radiology · 28d
Cleared Oct 26, 2017
OrthoVision
K173094 · LLZ
Ewoosoft Co., Ltd.
Radiology · 27d
Cleared Oct 25, 2017
Smart Photon Micro-current Device, Model: EP-300
K162652 · NFO
Li-Tek Electronic Technology Corporation
Neurology · 397d
Cleared Oct 25, 2017
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · MUI
Advance Medical Designs, Inc.
Radiology · 358d
Cleared Oct 25, 2017
iTotal Family Reusable Instrument Tray
K170226 · KCT
Conformis, Inc.
General Hospital · 273d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293 · DIO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Oct 25, 2017
SunCHECK
K170307 · IYE
Sun Nuclear Corporation
Radiology · 266d
Cleared Oct 25, 2017
DentureID Microchip
K170423 · PYQ
Cmp Industries, LLC
General Hospital · 254d
Cleared Oct 25, 2017
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
K170454 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 252d
Cleared Oct 25, 2017
Cortina™ Lumbar Cage System
K171914 · MAX
Neurostructures, Inc.
Orthopedic · 121d
Cleared Oct 25, 2017
Gel-Bead
K171946 · KRD
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Oct 25, 2017
CleanCision Wound Retraction and Protection System
K172132 · PQI
Prescient Surgical, Inc.
General & Plastic Surgery · 103d
Cleared Oct 25, 2017
3880 MRI Patient Monitoring System
K172200 · MWI
Iradimed Corporation
Cardiovascular · 96d
Cleared Oct 25, 2017
Ortus™ Expandable Lumbar Interbody Fusion System
K172334 · MAX
Atlas Spine, Inc.
Orthopedic · 84d
Cleared Oct 25, 2017
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software...
K172455 · IYO
Volcano Corporation
Radiology · 72d
Cleared Oct 25, 2017
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
K172600 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Oct 25, 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 55d
Cleared Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion...
K172626 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Oct 25, 2017
CosmoLock Pedicle Screw System
K172808 · NKB
Kalitec Direct, LLC
Orthopedic · 37d
Cleared Oct 25, 2017
Colorado Therapeutics Xenograft Implant
K172937 · FTM
Colorado Therapeutics, LLC
General & Plastic Surgery · 29d