Search FDA 510(k) Database

Cleared Jan 17, 2020

Bio-TackS Orthodontic Mini Implant

K190871 · OAT

Biocetec Co., Ltd.

Dental · 289d

Cleared Jan 17, 2020

C015

K192182 · OWB

Micronica Srl

Radiology · 158d

Cleared Jan 17, 2020

SoundBite Console, SoundBite Active Wire 18

K192211 · PDU

Soundbite Medical Solution, Inc.

Cardiovascular · 156d

Cleared Jan 17, 2020

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter,...

K192302 · MPB

Covidien, LLC

Gastroenterology & Urology · 147d

Cleared Jan 17, 2020

Study Watch with Irregular Pulse Monitor

K192415 · DXH

Verily Life Sciences, LLC

Cardiovascular · 135d

Cleared Jan 17, 2020

Black Diamond Navigation Instruments

K192495 · OLO

Osseus Fusion Systems

Orthopedic · 128d

Cleared Jan 17, 2020

MAGLUMI 2000 HCG/ß-HCG

K192547 · DHA

Shenzhen New Industries Biomedical...

Chemistry · 122d

Cleared Jan 17, 2020

Altera gas Sampling Lines

K192563 · CCK

Meditera Tibbi Malzeme San VE Tic AS

Anesthesiology · 122d

Cleared Jan 17, 2020

PicoLazer Laser System

K192583 · GEX

Rohrer Aesthetics, LLC

General & Plastic Surgery · 120d

Cleared Jan 17, 2020

SAC2 - Electrode Cream

K192606 · GYB

Spes Medica Srl

Neurology · 119d

Cleared Jan 17, 2020

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

K192635 · LZA

Wrp Asia Pacific Sdn. Bhd.

General Hospital · 116d

Cleared Jan 17, 2020

Asimov-MKS Imaging System

K192761 · IZI

Onlume, Inc.

General & Plastic Surgery · 109d

Cleared Jan 17, 2020

RxSight Insertion Device

K192926 · MSS

Rxsight, Inc.

Ophthalmic · 93d

Cleared Jan 17, 2020

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope...

K193007 · HIH

Lina Medical Aps

Obstetrics & Gynecology · 81d

Cleared Jan 17, 2020

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K193182 · FDT

Olympus Medical Systems Corp.

Gastroenterology & Urology · 60d

Cleared Jan 17, 2020

Merit ONE Snare System

K193507 · MMX

Merit Medical Systems, Inc.

Cardiovascular · 30d

Cleared Jan 17, 2020

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

K193509 · DYB

Acutus Medical, Inc.

Cardiovascular · 30d

Cleared Jan 17, 2020

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating...

K193543 · HRS

In2bones USA, LLC

Orthopedic · 28d

Cleared Jan 17, 2020

CustomizedBone Service

K193547 · GXN

Fin-Ceramica Faenza S.P.A.

Neurology · 28d

Cleared Jan 17, 2020

Dental Pain Eraser

K193570 · LWM

Synapse Dental

Dental · 25d

Cleared Jan 17, 2020

CareSens S Fit BT Blood Glucose Monitoring System

K193590 · NBW

I-Sens, Inc.

Chemistry · 25d

Cleared Jan 16, 2020

Maxxi Snore Sensor

K191095 · MNR

Neurovirtual USA, Inc.

Anesthesiology · 266d

Cleared Jan 16, 2020

Resectr Tissue Resection Device

K191538 · HIH

Boston Scientific Corporation

Obstetrics & Gynecology · 220d

Cleared Jan 16, 2020

Electric Breast Pump

K191802 · HGX

Ningbo Huiyoo Baby Products Co., Ltd.

Obstetrics & Gynecology · 197d