Search FDA 510(k) Database

Cleared Sep 06, 2019

Gem FlowCoupler System

K190499 · MVR

Baxter/ Synovis Micro Companies...

General & Plastic Surgery · 189d

Cleared Sep 06, 2019

Precision S 4K Sinuscope

K191102 · EOB

Stryker

Ear, Nose, Throat · 134d

Cleared Sep 06, 2019

Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc...

K191121 · LPL

Lentechs, LLC

Ophthalmic · 133d

Cleared Sep 06, 2019

Transvaginal Access Platform

K191294 · HEW

Applied Medical Resources Corp.

Obstetrics & Gynecology · 115d

Cleared Sep 06, 2019

Vacutore Air/Water Bottle Tubing

K191366 · OCX

Smartdata Suzhou Co., Ltd.

Gastroenterology & Urology · 107d

Cleared Sep 06, 2019

AcQMap High Resolution Imaging and Mapping System

K191392 · DQK

Acutus Medical, Inc.

Cardiovascular · 105d

Cleared Sep 06, 2019

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40...

K191435 · GZF

Nalu Medical, Inc.

Neurology · 99d

Cleared Sep 06, 2019

Venus Legacy Pro Device

K191528 · GEI

Venus Concept USA, Inc.

General & Plastic Surgery · 88d

Cleared Sep 06, 2019

Sure-Fine Insulin Syringes

K191531 · FMF

Shina Med Corporation

General Hospital · 88d

Cleared Sep 06, 2019

Willow Wearable Breast Pump 2.0

K191577 · HGX

Exploramed Nc7, Inc.

Obstetrics & Gynecology · 84d

Cleared Sep 06, 2019

TTC Phantom Intramedullary Nail System

K191782 · HSB

Paragon 28, Inc.

Orthopedic · 66d

Cleared Sep 06, 2019

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive...

K191845 · PGY

Barco N.V.

Radiology · 58d

Cleared Sep 06, 2019

EVO Platform

K192160 · GEX

Quanta System Spa

General & Plastic Surgery · 28d

Cleared Sep 06, 2019

Aquilion ONE (TSX-306A/3) V10.0

K192188 · JAK

Canon Medical Systems Corporation

Radiology · 24d

Cleared Sep 06, 2019

Lumify Diagnostic Ultrasound System

K192226 · IYN

Philips Health Care

Radiology · 21d

Cleared Sep 05, 2019

EVIS EXERA III Bronchovideoscope Olympus BF-XT190

K183419 · EOQ

Olympus Medical Systems Corp.

Ear, Nose, Throat · 269d

Cleared Sep 05, 2019

FUJIFILM Ultrasonic Endoscope

K183433 · ODG

Fujifilm Corporation

Gastroenterology & Urology · 268d

Cleared Sep 05, 2019

Holinwon 30

K183563 · GEX

Wontech Co., Ltd.

General & Plastic Surgery · 259d

Cleared Sep 05, 2019

GM501 Wash

K190383 · MQL

Hamilton Thorne, Inc.

Obstetrics & Gynecology · 198d

Cleared Sep 05, 2019

bili-hut

K190899 · LBI

Little Sparrows Technologies, Inc.

General Hospital · 150d

Cleared Sep 05, 2019

SmarTemp X1

K190930 · EBG

Parkell, Inc.

Dental · 148d

Cleared Sep 05, 2019

Advocate Non-Contact Infrared Thermometer

K191004 · FLL

Broadmaster Biotech, Corp.

General Hospital · 142d

Cleared Sep 05, 2019

SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

K191343 · MED

STERIS Corporation

General Hospital · 108d

Cleared Sep 05, 2019

Persona Revision Knee System

K191625 · JWH

Zimmer, Inc.

Orthopedic · 79d