Search FDA 510(k) Database

Cleared Jul 19, 2023

LF900

K231437 · IRP

Daesung Maref Co., Ltd.

Physical Medicine · 63d

Cleared Jul 19, 2023

RenaPure Endotoxin Retentive Filter

K231410 · FIP

Evoqua Water Technologies, LLC

Gastroenterology & Urology · 65d

Cleared Jul 19, 2023

TAMINA 3.5mm Proximal Humerus System

K231292 · HRS

Bonebridge AG

Orthopedic · 76d

Cleared Jul 19, 2023

syngo.CT Lung CAD (Version VD30)

K231157 · OEB

Siemens Healthcare GmbH

Radiology · 86d

Cleared Jul 19, 2023

BACK 3

K230037 · PBX

Swims America Corp

General & Plastic Surgery · 194d

Cleared Jul 19, 2023

Nu-beca Transcutaneous Electrical Nerve Stimulation

K223151 · NUH

Nu-Beca & Maxcellent Co.

Neurology · 287d

Cleared Jul 19, 2023

AXINON® LDL-p Test System

K210801 · MRR

Numares AG

Chemistry · 854d

Cleared Jul 18, 2023

Forma Medical Headless Compression Screw

K230945 · HWC

Forma Medical, Inc.

Orthopedic · 105d

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