Search FDA 510(k) Database

Cleared Feb 28, 2023

LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System

K230245 · NKB

L & K Biomed Co., Ltd.

Orthopedic · 29d

Cleared Feb 28, 2023

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

K230038 · LCX

Guangzhou Decheng Biotechnology Co.,...

Chemistry · 53d

Cleared Feb 28, 2023

IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...

K223618 · OHT

Shenzhen Ulike Smart Electronics Co.,...

General & Plastic Surgery · 85d

Cleared Feb 28, 2023

REVCON (TM) Screw System

K223392 · HWC

Voom Medical Devices, Inc.

Orthopedic · 112d

Cleared Feb 28, 2023

SurBlate Ablation System

K223272 · NEY

Mima-Pro Scientific, Inc.

General & Plastic Surgery · 127d

Cleared Feb 28, 2023

8X-10-6XXX Camera Head

K223116 · GCJ

Santa Barbara Imaging Systems

General & Plastic Surgery · 148d

Cleared Feb 28, 2023

Mobility Scooter (Models: W3431Q, W3431R)

K222507 · INI

Zhejiang Innuovo Rehabilitation...

Physical Medicine · 194d

Cleared Feb 28, 2023

PuraStat

K222481 · QAU

3-D Matrix, Inc.

General & Plastic Surgery · 195d

Cleared Feb 28, 2023

EXPLORER AIR® II

K222240 · IZI

Surgvision GmbH

General & Plastic Surgery · 217d

Cleared Feb 28, 2023

HARMONIC 700 Shears

K221790 · LFL

Ethicon Endo-Surgery, LLC

General & Plastic Surgery · 252d

Cleared Feb 28, 2023

AccuICAS

K221711 · QHA

ArteryFlow Technology Co., Ltd.

Radiology · 260d

Cleared Feb 28, 2023

U2 Total Knee System-PF+

K221705 · MBH

United Orthopedic Corporation

Orthopedic · 260d

Cleared Feb 28, 2023

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova®...

K221641 · FRC

Terragene S.A.

General Hospital · 267d

Cleared Feb 28, 2023

SpectraWAVE Imaging System

K221257 · NQQ

Spectrawave, Inc.

Cardiovascular · 302d

Cleared Feb 27, 2023

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

K223253 · EIH

Arum Dentistry Co., Ltd.

Dental · 129d

Cleared Feb 27, 2023

BENCOX Mirabo Z Cup Cortinium

K223223 · LPH

Corentec Co., Ltd.

Orthopedic · 133d

Cleared Feb 27, 2023

Ogmend® Implant Enhancement System

K223075 · QVI

Woven Orthopedic Technologies

Orthopedic · 150d

Cleared Feb 27, 2023

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

K222173 · OCX

Saneso, Inc.

Gastroenterology & Urology · 221d

Cleared Feb 27, 2023

Milli Vaginal Dilator

K220035 · HDX

Materna Medical

Obstetrics & Gynecology · 418d

Cleared Feb 27, 2023

Idylla MSI Test

K211181 · PZJ

Biocartis NV

Pathology · 678d

Cleared Feb 26, 2023

Handheld Pulse Oximeter

K213431 · DQA

Shenzhen Witleaf Medical Electronics...

Anesthesiology · 493d

Cleared Feb 25, 2023

CompuFlo Epidural Computer Controlled Anesthesia System

K221702 · FMF

Milestone Scientific, Inc.

Anesthesiology · 257d

Cleared Feb 24, 2023

EsoCheck Cell Collection Device

K230339 · EOX

Lucid Diagnostics, Inc.

Gastroenterology & Urology · 17d

Cleared Feb 24, 2023

Veloxion System

K230205 · FJL

Corinth Medtech, Inc.

Gastroenterology & Urology · 30d