Search FDA 510(k) Database

Cleared Nov 21, 2018

PlayMakar Sport Muscle Stimulator, Model PRO-500

K182581 · NUH

Playmakar, Inc.

Neurology · 63d

Cleared Nov 21, 2018

PINPOINT Endoscopic Fluorescence Imaging System

K182606 · GCJ

Novadaq Technologies Ulc. (Now A Part...

General & Plastic Surgery · 61d

Cleared Nov 21, 2018

ARK EDDP Assay

K182779 · DJR

ARK Diagnostics, Inc.

Toxicology · 51d

Cleared Nov 21, 2018

Roth Net Retriever Product Line

K182909 · FDI

United States Endoscopy Group, Inc.

Gastroenterology & Urology · 35d

Cleared Nov 21, 2018

Heli-FX EndoAnchor System

K182957 · OTD

Medtronic Vascular, Inc.

Cardiovascular · 28d

Cleared Nov 21, 2018

Isolette 8000 Plus

K182977 · FMZ

Draeger Medical Systems, Inc.

General Hospital · 26d

Cleared Nov 20, 2018

NuVasive Monolith Cervical Corpectomy System

K180550 · PLR

Nu Vasive, Incorporated

Orthopedic · 264d

Cleared Nov 20, 2018

GC Acrylic Primer

K180917 · KLE

GC America, Inc.

Dental · 225d

Cleared Nov 20, 2018

Vitrea CT Brain Perfusion

K181247 · LLZ

Vital Images, Inc.

Radiology · 194d

Cleared Nov 20, 2018

MR Compatible Aspiration Kit

K181731 · GWG

Mri Interventions, Inc.

Neurology · 144d

Cleared Nov 20, 2018

ARIX Sternal System

K181806 · HRS

Jeil Medical Corporation

Orthopedic · 137d

Cleared Nov 20, 2018

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low...

K181857 · LZA

Kossan International Sdn Bhd

General Hospital · 132d

Cleared Nov 20, 2018

Infrared Thermometer

K182133 · FLL

Shenzhen AOJ Medical Technology Co.,...

General Hospital · 106d

Cleared Nov 20, 2018

CodMan Certas Plus Programmable Valve

K182265 · JXG

Integra Lifesciences Corp.

Neurology · 91d

Cleared Nov 20, 2018

Orbit Subretinal Delivery System

K182274 · FMF

Orbit Biomedical, Inc.

Ophthalmic · 90d

Cleared Nov 20, 2018

TPH Spectra ST Flowable Composite Restorative

K182288 · EBF

Dentsply Sirona

Dental · 89d

Cleared Nov 20, 2018

6MP Color LCD Monitor (C61W+)

K182291 · PGY

Shenzhen Beacon Display Technology...

Radiology · 89d

Cleared Nov 20, 2018

COCET Digital Thermometer (Models...

K182652 · FLL

Kangfu Medical Equipment Factory

General Hospital · 57d

Cleared Nov 20, 2018

Telepack X LED

K182696 · FET

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 54d

Cleared Nov 20, 2018

Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System

K182715 · IYN

Shenzhen Wisonic Medical Technology...

Radiology · 54d

Cleared Nov 20, 2018

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable...

K182931 · FRC

Steris Corporations

General Hospital · 29d

Cleared Nov 19, 2018

AI-ECG Platform

K180432 · DQK

Shenzhen Carewell Electronics., Ltd.

Cardiovascular · 272d

Cleared Nov 19, 2018

R3 Anteverted Liners

K182535 · MBL

Smith & Nephew, Inc.

Orthopedic · 66d

Cleared Nov 19, 2018

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

K182654 · NGG

Safecare Biotech (Hangzhou) Co., Ltd.

Toxicology · 55d