Search FDA 510(k) Database

Cleared Nov 10, 2021

Powder Free Nitrile Patient Examination Gloves, Blue Color

K210779 · LZA

Shandong Shangwei Medical Products...

General Hospital · 240d

Cleared Nov 10, 2021

VSP® Orthopedics System

K211244 · PBF

3D Systems

Orthopedic · 198d

Cleared Nov 10, 2021

Lunit INSIGHT CXR Triage

K211733 · QFM

Lunit, Inc.

Radiology · 159d

Cleared Nov 10, 2021

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7...

K211975 · OTN

Caldera Medical, Inc.

Gastroenterology & Urology · 138d

Cleared Nov 10, 2021

ESSENZ Patient Monitor

K212003 · DXJ

Livanova Deutschland, GmbH

Cardiovascular · 135d

Cleared Nov 10, 2021

eKuore Pro 4T - REF EP0098

K212013 · DQD

Chip Ideas Electronics S.L.

Cardiovascular · 135d

Cleared Nov 10, 2021

Reverso

K212107 · GEI

Intelis Instruments , Ltd.

General & Plastic Surgery · 127d

Cleared Nov 10, 2021

Disposable Automatic Core Biopsy Instrument

K212284 · KNW

Suzhou Leapmed Healthcare Corporation

Gastroenterology & Urology · 112d

Cleared Nov 10, 2021

AlignRT Plus

K212583 · IYE

Vision Rt, Ltd.

Radiology · 86d

Cleared Nov 10, 2021

More-Cell-System

K212659 · PMU

Agency For Medical Innovations GmbH

Obstetrics & Gynecology · 79d

Cleared Nov 10, 2021

RTapp

K212887 · LLZ

Segana, Inc.

Radiology · 61d

Cleared Nov 10, 2021

Diode laser therapy system

K212978 · GEX

Beijing Unt Technology Co., Ltd.

General & Plastic Surgery · 54d

Cleared Nov 10, 2021

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

K213089 · FPA

Ivenix, Inc.

General Hospital · 47d

Cleared Nov 10, 2021

Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity...

K213389 · JWH

Conformis, Inc.

Orthopedic · 26d

Cleared Nov 09, 2021

BESPA Charcot System

K202326 · HWC

Bespa Global, LLC

Orthopedic · 449d

Cleared Nov 09, 2021

Medical Face Masks, Model Name:MY020003

K211165 · FXX

Huizhou Jie Bai Purification Co., Ltd.

General Hospital · 204d

Cleared Nov 09, 2021

FreedomEdge(R) Syringe Infusion System

K211206 · FRN

Repro-Medical System, Inc., Dba Koru...

General Hospital · 201d

Cleared Nov 09, 2021

RMU-2000 Automated Chest Compression System

K211289 · DRM

Defibtech, LLC

Cardiovascular · 195d

Cleared Nov 09, 2021

Comby EEG Caps

K211315 · GXY

Pamel D.O.O

Neurology · 193d

Cleared Nov 09, 2021

Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT,...

K211517 · GEX

Convergent Laser Technologies

General & Plastic Surgery · 176d

Cleared Nov 09, 2021

Vektor Computational ECG Mapping System (vMap)

K211546 · DQK

Vektor Medical, Inc.

Cardiovascular · 174d

Cleared Nov 09, 2021

Sensual Massage, Ultra Pure

K211967 · NUC

Dreambrands, Inc.

Obstetrics & Gynecology · 138d

Cleared Nov 09, 2021

BodySculp

K212331 · PKT

Rohrer Aesthetics, LLC

General & Plastic Surgery · 105d

Cleared Nov 09, 2021

Surgical Face Mask

K212526 · FXX

Suzhou Janee Medical Technology Co.,...

General Hospital · 90d