Search FDA 510(k) Database

7,018 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19033–19056 of 174,061
Cleared Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
K192918 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 128d
Cleared Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K192922 · NQQ
Gentuity, LLC
Cardiovascular · 127d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015 · LJS
Access Vascular, Inc.
General Hospital · 114d
Cleared Feb 20, 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · PHX
Exactech, Inc.
Orthopedic · 105d
Cleared Feb 20, 2020
Largo PEEK Interbody System
K193255 · MAX
Flospine, LLC
Orthopedic · 86d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303 · KLW
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Feb 20, 2020
WIN Flexible Nail System
K193533 · JDS
Biomet, Inc.
Orthopedic · 62d
Cleared Feb 20, 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596 · DQY
Reflow Medical
Cardiovascular · 59d
Cleared Feb 19, 2020
D R Burton OxyPAP
K192000 · BWF
D R Burton Healthcare, LLC
Anesthesiology · 208d
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460 · PUM
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Feb 19, 2020
densitas densityai
K192973 · LLZ
Densitas, Inc.
Radiology · 118d
Cleared Feb 19, 2020
speX Support Catheter
K193012 · DQY
Reflow Medical
Cardiovascular · 113d
Cleared Feb 19, 2020
Wego-Stainless Steel
K193209 · GAQ
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 19, 2020
ClearCam System
K200228 · GCJ
Clearcam, LLC
General & Plastic Surgery · 20d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · NDC
Companion Medical, Inc.
Chemistry · 355d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · PSZ
Access Bio, Inc.
Microbiology · 256d
Cleared Feb 18, 2020
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing...
K192381 · LBH
Scientific Pharmaceuticals
Dental · 172d
Cleared Feb 18, 2020
Mixing and Delivery System
K192674 · FMF
Bone Solutions, Inc.
General & Plastic Surgery · 145d
Cleared Feb 18, 2020
Safety Insulin Pen Needle
K192677 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 145d
Cleared Feb 18, 2020
Vita Flex CR System with LLI
K192894 · MQB
Carestream Health, Inc.
Radiology · 130d
Cleared Feb 18, 2020
MOJAVE Expandable Interbody System
K193203 · MAX
K2m, Inc.
Orthopedic · 90d
Cleared Feb 18, 2020
Ashvins
K200132 · LLZ
Medicalcommunications GmbH
Radiology · 28d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Philips Health Care
Radiology · 25d
Cleared Feb 16, 2020
Swan-Ganz Catheters
K193466 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 62d