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
18553–18576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2020
Physiq
K202079 · IPF
El.En Electronic Engineering Spa
Physical Medicine · 121d
Cleared Nov 25, 2020
GLOBAL UNITE™ Platform Shoulder System
K202098 · PHX
Depuy Ireland UC
Orthopedic · 119d
Cleared Nov 25, 2020
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and...
K202194 · MBH
Depuy Ireland UC
Orthopedic · 112d
Cleared Nov 25, 2020
Dermatological Carbon Dioxide Laser Systems
K202250 · GEX
Zhuolu Jontelaser Manufacturing...
General & Plastic Surgery · 107d
Cleared Nov 25, 2020
PRE-MILLED Abutment
K202269 · NHA
Mit Global Co., Ltd.
Dental · 106d
Cleared Nov 25, 2020
T3 Platform software
K202306 · MWI
Etiometry, Inc.
Cardiovascular · 103d
Cleared Nov 25, 2020
Night Guard
K202465 · MQC
3D Diagnostix, Inc.
Dental · 90d
Cleared Nov 25, 2020
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
K202470 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 89d
Cleared Nov 25, 2020
Sterile bone screw (PEEK ACL screw)
K202883 · MBI
Osteonic Co., Ltd.
Orthopedic · 58d
Cleared Nov 25, 2020
The Multimodality Advanced Vessel Analysis
K203216 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Nov 25, 2020
CarboClear X Pedicle Screw System
K203317 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 15d
Cleared Nov 24, 2020
ACENT™ Central Venous Catheter
K193158 · FOZ
Global Medikit Limited
General Hospital · 376d
Cleared Nov 24, 2020
G-CEM ONE
K200798 · EMA
GC America, Inc.
Dental · 243d
Cleared Nov 24, 2020
RF Surgical Generator
K200931 · GEI
Fulwell, LLC
General & Plastic Surgery · 231d
Cleared Nov 24, 2020
Medical surgical mask
K201622 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 162d
Cleared Nov 24, 2020
eKuore One Wireless Electronic Interface for stethoscope
K201742 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 152d
Cleared Nov 24, 2020
Monet Curing Laser
K201904 · QNF
CAO Group, Inc.
Dental · 138d
Cleared Nov 24, 2020
NUVO Implant System – NUVO Instrument Kit Cases
K202515 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 84d
Cleared Nov 24, 2020
Promisemed Triple Safety Pen Needle
K202682 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 70d
Cleared Nov 24, 2020
OptoMonitor 3
K202943 · DXO
Opsens, Inc.
Cardiovascular · 55d
Cleared Nov 24, 2020
PolyLock Plating System
K202959 · HRS
Fusion Orthopedics, LLC
Orthopedic · 55d
Cleared Nov 24, 2020
Anterior Cervical Plate System
K202972 · KWQ
Nutech Spine and Biologics
Orthopedic · 55d
Cleared Nov 24, 2020
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2...
K203024 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 53d
Cleared Nov 24, 2020
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
K203081 · GAS
Lsi Solutions
General & Plastic Surgery · 42d