Search FDA 510(k) Database

Cleared Feb 21, 2020

Biatain Silicone Ag

K191536 · FRO

Coloplast A/S

General & Plastic Surgery · 256d

Cleared Feb 21, 2020

Beamscan MR

K191646 · IYE

Ptw-Freiburg...

Radiology · 246d

Cleared Feb 21, 2020

Cardiac Monitor 1500

K191697 · DSB

Zynex Medical, Inc.

Cardiovascular · 241d

Cleared Feb 21, 2020

ULTepap Expiratory Positive Airway Pressure (EPAP) Device

K191728 · OHP

Bryggs Medical, LLC

Anesthesiology · 239d

Cleared Feb 21, 2020

DORO LUCENT® iXI and iMRI Headrest System

K191740 · HBL

Pro-Med Instruments GmbH

Neurology · 235d

Cleared Feb 21, 2020

Upper Arm Blood Pressure Monitor

K191894 · DXN

Shenzhen Zhengkang Technology Co., Ltd.

Cardiovascular · 221d

Cleared Feb 21, 2020

Tina-quant C-Reactive Protein IV

K192072 · DCN

Roche Diagnostics Operations (Rdo)

Immunology · 203d

Cleared Feb 21, 2020

UCLA CCM Abutment

K192263 · NHA

Dio Corporation

Dental · 184d

Cleared Feb 21, 2020

Coolief Radiofrequency Generator (CRG) System

K192491 · GXD

Avanos Medical, Inc.

Neurology · 163d

Cleared Feb 21, 2020

Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60

K192600 · GEX

Quanta System Spa

General & Plastic Surgery · 154d

Cleared Feb 21, 2020

PatCom Single-Use Introducer

K192691 · FED

H&A Mui Enterprises, Inc.

Gastroenterology & Urology · 148d

Cleared Feb 21, 2020

Glenoid Baseplate with Screw

K192799 · PHX

Fx Shoulder USA, Inc.

Orthopedic · 144d

Cleared Feb 21, 2020

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

K192832 · JAK

Canon Medical Systems Corporation

Radiology · 142d

Cleared Feb 21, 2020

OASIS MRI System

K192851 · LNH

Hitachi Healthcare Americas

Radiology · 141d

Cleared Feb 21, 2020

TGS Guidewire and updated Scopis Software

K193118 · PGW

Stryker Ent

Ear, Nose, Throat · 101d

Cleared Feb 21, 2020

LightForce Orthodontic System (LFO System)

K200148 · NJM

Lightforce Orthodontics

Dental · 30d

Cleared Feb 21, 2020

3MP Monochrome Digital Mammography LCD Monitor MS-S300

K200161 · PGY

Jvckenwood Corporation

Radiology · 30d

Cleared Feb 21, 2020

SmoothSkin Pure

K200184 · OHT

Cyden Limited

General & Plastic Surgery · 28d

Cleared Feb 20, 2020

SDS2.2 dental implant

K190406 · DZE

Sds Swiss Dental Solutions AG

Dental · 364d

Cleared Feb 20, 2020

Flowart

K190806 · FPA

Asset Medikal Tasarim As.

General Hospital · 328d

Cleared Feb 20, 2020

X-MIND Trium

K191719 · MUH

De Gotzen S.R.L.

Radiology · 239d

Cleared Feb 20, 2020

Potenza

K192545 · GEI

Jeisys Medical Incorporated

General & Plastic Surgery · 157d

Cleared Feb 20, 2020

Gemini 810+980 Soft Tissue Laser

K192617 · GEX

Azena Medical, LLC

General & Plastic Surgery · 150d

Cleared Feb 20, 2020

ApneaTrak

K192624 · OLV

Cadwell Industries, Inc.

Neurology · 150d