Search FDA 510(k) Devices

Cleared Jul 18, 2023

Robotic Graft Delivery Instruments

K230716 · OLO

Medtronic Sofamor Danek, Inc.

Orthopedic · 125d

Cleared Jul 18, 2023

Bone Chamber Implant

K223339 · DZE

Megagen Implant Co., Ltd.

Dental · 259d

Cleared Jul 18, 2023

Hypodermic Syringes & Needle

K222925 · FMF

Lifelong Meditech Private Limited

General Hospital · 295d

Cleared Jul 18, 2023

TRUST

K221107 · PNP

Rgorithm Korea

Dental · 459d

Cleared Jul 18, 2023

FMT Reusable Temperature Probes

K213100 · FLL

Metko Medikal VE Ttbbi Cihazlar D1s...

General Hospital · 662d

Cleared Jul 17, 2023

Avitus® DragonWing Large Volume Autograft Delivery System

K231456 · FMF

Avitus Orthopaedics, Inc.

Orthopedic · 59d

Cleared Jul 17, 2023

ARIX Ankle System

K231441 · HRS

Jeil Medical Corporation

Orthopedic · 60d

Cleared Jul 17, 2023

iTotal Identity Knee Replacement System

K230846 · JWH

Conformis, Inc.

Orthopedic · 111d

Cleared Jul 17, 2023

Revital-Ox PAA High Level Disinfectant Chemical Indicator

K230558 · JOJ

STERIS Corporation

General Hospital · 139d

Cleared Jul 17, 2023

OPTIX H2 Patient Specific Instrument System

K230462 · HSN

Vilex, LLC

Orthopedic · 146d

Cleared Jul 17, 2023

FloNavi Open Field Fluorescence Imaging System

K230407 · OWN

Guangdong Optomedic Technologies, Inc.

General & Plastic Surgery · 152d

Cleared Jul 17, 2023

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

K230395 · FXX

Durio Ppe Sdn Bhd

General Hospital · 153d

Cleared Jul 17, 2023

Arthrex Intramedullary Nails

K230257 · HSB

Arthrex, Inc.

Orthopedic · 167d

Cleared Jul 17, 2023

“POINT” Kinguide Agile Hybrid Navigation System

K230087 · OLO

Point Robotics MedTech, Inc.

Orthopedic · 186d

Cleared Jul 17, 2023

LaserME

K230077 · GEX

Neauvia North America

General & Plastic Surgery · 188d

Cleared Jul 17, 2023

TRULIANT® E-PX Tibial Inserts

K223252 · JWH

Exactech, Inc.

Orthopedic · 269d

Cleared Jul 17, 2023

Fibroid Mapping Reviewer Application (FMRA)

K222683 · LLZ

Nesa Medtech Private Limited

Radiology · 314d

Cleared Jul 17, 2023

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum...

K213953 · JKA

Becton, Dickinson and Company

Chemistry · 577d

Cleared Jul 17, 2023

Pulse Oximeter

K211143 · DQA

Shenzhen Brav Electronic Technologies...

Anesthesiology · 822d

Cleared Jul 16, 2023

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate...

K231460 · KWQ

K&J Consulting Corp.

Orthopedic · 58d

Cleared Jul 14, 2023

PathLoc SI Joint Fusion System

K231841 · OUR

L & K Biomed Co., Ltd.

Orthopedic · 22d

Cleared Jul 14, 2023

FlowSaver Blood Return System (80-101)

K231782 · CAC

Inari Medical, Inc.

Cardiovascular · 28d

Cleared Jul 14, 2023

Ez3D-i /E3

K231757 · QIH

Ewoosoft Co., Ltd.

Radiology · 28d

Cleared Jul 14, 2023

Mobility Scooter (Models: W3431D)

K231428 · INI

Zhejiang Innuovo Rehabilitation...

Physical Medicine · 58d