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
25777–25800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2018
UF(II) Wide Fixture
K173975 · DZE
Dio Corporation
Dental · 154d
Cleared Jun 01, 2018
Bowel Management Device, Bowel Management Irrigation Set
K180026 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 149d
Cleared Jun 01, 2018
Omnipod DASH Insulin Management System
K180045 · LZG
Insulet Corporation
General Hospital · 144d
Cleared Jun 01, 2018
BioNude Lubricant
K180136 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 135d
Cleared Jun 01, 2018
InMode System with Fractora3D/3D-90 Applicators
K180189 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 129d
Cleared Jun 01, 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · DQK
Biosense Webster, Inc.
Cardiovascular · 123d
Cleared Jun 01, 2018
Single Use MultiClip Device
K180325 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 116d
Cleared Jun 01, 2018
Hair Up
K180617 · OAP
Y & J Bio Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jun 01, 2018
Colonic Plus Regular, Small, and Straight Shape Hydrokit
K180800 · KPL
Colonic Plus
Gastroenterology & Urology · 66d
Cleared Jun 01, 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management...
K180855 · OMP
Kci USA, Inc.
General & Plastic Surgery · 60d
Cleared May 31, 2018
Single Use Arthroscopic Electrode (with Pencil)
K170703 · HRX
Modern Medical Equipment...
Orthopedic · 449d
Cleared May 31, 2018
ETCO2 Sensor
K171828 · CCK
Orantech, Inc.
Anesthesiology · 345d
Cleared May 31, 2018
ToFscan
K172690 · KOI
Idmed
Anesthesiology · 267d
Cleared May 31, 2018
EndoWrist 5mm Thoracic Grasper
K173415 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 211d
Cleared May 31, 2018
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K173906 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 160d
Cleared May 31, 2018
AEVUMED PHANTOM Suture Anchors
K180464 · MBI
Aevumed, Inc.
Orthopedic · 99d
Cleared May 31, 2018
ATEC Universal Spacer System
K180480 · PHM
Alphatec Spine, Inc.
Orthopedic · 97d
Cleared May 31, 2018
Sternal Cable System
K180582 · JDQ
A & E Medical Corporation
Orthopedic · 87d
Cleared May 31, 2018
SOMAVAC Device
K180606 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 85d
Cleared May 31, 2018
ACUSON SC2000 Diagnostic Ultrasound System
K181098 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
K181122 · DSP
Datascope Corp.
Cardiovascular · 31d
Cleared May 31, 2018
Interventional Workspot
K181177 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 30, 2018
ScioCardio ECG Transmitter
K171019 · DRG
Synergen Technology Labs, LLC
Cardiovascular · 420d
Cleared May 30, 2018
MN-111
K172825 · FLE
W&H Sterilization S.R.L.
General Hospital · 254d