Search FDA 510(k) Database

Cleared Jul 28, 2023

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

K231073 · QAI

Esthetic Medical, Inc.

General & Plastic Surgery · 105d

Cleared Jul 28, 2023

FLUOBEAM® LX Red

K230898 · QDG

Fluoptics Sas

General & Plastic Surgery · 119d

Cleared Jul 28, 2023

BlueStar and BlueStar Rx

K230813 · NDC

Welldoc, Inc.

Chemistry · 126d

Cleared Jul 28, 2023

Pathfinder Endoscope Overtube with Balloon Device

K230801 · FED

Neptune Medical, Inc.

Gastroenterology & Urology · 127d

Cleared Jul 28, 2023

Quantisal™ II Oral Fluid Collection Device

K223781 · PJD

Immunalysis Corporation

Chemistry · 224d

Cleared Jul 28, 2023

i-STAT CG8+ cartridge with the i-STAT 1 System

K223710 · CGA

Abbott Point of Care, Inc.

Chemistry · 228d

Cleared Jul 28, 2023

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

K223670 · DPS

Mesi, Development of Medical Devices,...

Cardiovascular · 233d

Cleared Jul 28, 2023

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

K222902 · DPS

Edan Instruments, Inc.

Cardiovascular · 308d

Cleared Jul 28, 2023

FlowStar Touch Digital Mixer Flowmeter

K222794 · BZR

Baldus Sedation GmbH & Co. KG

Anesthesiology · 315d

Cleared Jul 28, 2023

HJY VisualNext Endoscopic Vision System

K222735 · GWG

Hjy Smart Medical Device Co., Ltd.

Neurology · 322d

Cleared Jul 28, 2023

PatCom Distal Chip Endoscope

K222587 · EOB

H&A Mui Enterprises, Inc.

Ear, Nose, Throat · 336d

Cleared Jul 27, 2023

Therm-X

K231912 · IRP

Zenith Technical Innovations

Physical Medicine · 28d

Cleared Jul 27, 2023

SURGIVISIO Device

K231886 · OLO

Ecential Robotics

Orthopedic · 30d

Cleared Jul 27, 2023

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

K231555 · OHS

iSMART Developments, Ltd.

General & Plastic Surgery · 58d

Cleared Jul 27, 2023

Altaviz Needle Kit II

K231261 · FMI

Altaviz, LLC

General Hospital · 87d

Cleared Jul 27, 2023

IBS-B MIS Beveled Screw System

K231236 · HWC

In2bones USA, LLC

Orthopedic · 90d

Cleared Jul 27, 2023

MDx-Chex for BC-GN

K231223 · PMN

Streck

Microbiology · 90d

Cleared Jul 27, 2023

MDx-Chex for BC-GP

K231221 · PMN

Streck

Microbiology · 90d

Cleared Jul 27, 2023

Brainomix 360 Triage ICH

K231195 · QAS

Brainomix Limited

Radiology · 91d

Cleared Jul 27, 2023

R2P Navicross

K231044 · DQY

Terumo Medical Corporation

Cardiovascular · 106d

Cleared Jul 27, 2023

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...

K230838 · FYA

Cardinal Health200, LLC

General Hospital · 122d

Cleared Jul 27, 2023

Rapid Aneurysm Triage and Notification

K230074 · QFM

Ischemaview, Inc.

Radiology · 198d

Cleared Jul 27, 2023

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...

K223591 · QOF

Roche Molecular Systems, Inc.

Microbiology · 238d

Cleared Jul 27, 2023

Teleflex Rusch SoftSimplastic Foley Catheters

K212077 · EZL

Teleflexmedical, Inc.

Gastroenterology & Urology · 755d