Search FDA 510(k) Database

Cleared Mar 17, 2023

Ablacath™ Mapping Catheter

K223666 · MTD

Ablacon, Inc.

Cardiovascular · 100d

Cleared Mar 17, 2023

InThrill Thrombectomy System

K223613 · QEW

Inari Medical, Inc.

Cardiovascular · 102d

Cleared Mar 17, 2023

Viz AAA

K223443 · QFM

Viz. Ai, Inc.

Radiology · 123d

Cleared Mar 17, 2023

DeGen Impulse AM™ System

K223418 · MAX

Degen Medical

Orthopedic · 127d

Cleared Mar 17, 2023

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...

K223162 · LDJ

Healgen Scientific, LLC

Toxicology · 161d

Cleared Mar 17, 2023

Alio

K223073 · DRG

Alio, Inc.

Gastroenterology & Urology · 168d

Cleared Mar 17, 2023

Prism

K222101 · HCC

Graymatters Health , Ltd.

Neurology · 242d

Cleared Mar 17, 2023

FemDx FalloView

K221965 · MKO

Femdx Medsystems, Inc.

Obstetrics & Gynecology · 255d

Cleared Mar 17, 2023

KARL STORZ Bipolar Resectoscopes with HF Cable

K221893 · FJL

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 261d

Cleared Mar 17, 2023

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

K221782 · DRS

Merit Medical Pte. , Ltd.

Cardiovascular · 269d

Cleared Mar 17, 2023

NeuroRPM

K221772 · GYD

New Touch Digital, Inc.

Neurology · 269d

Cleared Mar 17, 2023

SMR Stemless Anatomic

K221758 · PKC

Lima Corporate S.P.A.

Orthopedic · 274d

Cleared Mar 17, 2023

MagVenture TMS Atlas Neuro Navigation System

K221544 · HAW

Tonica Elektronik A/S

Neurology · 294d

Cleared Mar 17, 2023

RCRP Flex reagent cartridge

K221119 · DCN

Siemens Healthcare Diagnostics, Inc.

Immunology · 333d

Cleared Mar 17, 2023

Simplexa COVID-19 & Flu A/B Direct

K220963 · QOF

Diasorin Molecular, LLC

Microbiology · 350d

Cleared Mar 16, 2023

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

K230404 · PCH

Biofire Diagnostics, LLC

Microbiology · 29d

Cleared Mar 16, 2023

BENCOX Delta Option Heads

K223828 · LZO

Corentec Co., Ltd.

Orthopedic · 85d

Cleared Mar 16, 2023

Electric Wheelchair

K223393 · ITI

Shanghai Bangbang Robotics Co., Ltd.

Physical Medicine · 128d

Cleared Mar 16, 2023

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...

K223154 · OBP

Magstim Company, Ltd.

Neurology · 161d

Cleared Mar 16, 2023

Senhance Surgical System

K223095 · NAY

Asensus Surgical, Inc.

General & Plastic Surgery · 167d

Cleared Mar 16, 2023

MilkMate Breast Pump

K223084 · HGX

Milkmate Products, Inc.

Obstetrics & Gynecology · 167d

Cleared Mar 16, 2023

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...

K222839 · NAY

Intuitive Surgical, Inc.

General & Plastic Surgery · 177d

Cleared Mar 16, 2023

iSyncBrain©-C

K222838 · OLU

iMediSync, Inc.

Neurology · 177d

Cleared Mar 16, 2023

Nitrile Examination Gloves

K222813 · LZA

Ecoglove Medical Manufacturing...

General Hospital · 178d