Search FDA 510(k) Database

Cleared Dec 16, 2020

CREED™ Cannulated Screws

K200291 · HWC

Glw Medical, Inc.

Orthopedic · 315d

Cleared Dec 16, 2020

Lucero Medical Cervical Cage System

K200549 · ODP

Lucero Medical, LLC

Orthopedic · 288d

Cleared Dec 16, 2020

NRFit® Caps, Male and Female Neuraxial Tip Caps

K201031 · QEH

International Medical Industries, Inc.

General Hospital · 240d

Cleared Dec 16, 2020

Pasteur Pipette 3mL, Pasteur Pipette 1mL

K201213 · MQK

Hertart Aps

Obstetrics & Gynecology · 225d

Cleared Dec 16, 2020

Disposable Stone Extraction basket

K201509 · LQR

Hangzhou AGS MedTech Co., Ltd.

Gastroenterology & Urology · 194d

Cleared Dec 16, 2020

dermalux Flex MD

K202028 · ILY

Aesthetic Technology, Ltd.

General & Plastic Surgery · 147d

Cleared Dec 16, 2020

Medical Surgical Mask

K202029 · FXX

Beijing Biosis Healing Biolog Ical...

General Hospital · 147d

Cleared Dec 16, 2020

CreoDent Solidex Customized Abutment and Screw

K202095 · NHA

Creodent Prosthetics, Ltd.

Dental · 140d

Cleared Dec 16, 2020

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...

K202289 · KWS

Stryker GmbH

Orthopedic · 126d

Cleared Dec 16, 2020

HydroMARK Breast Biopsy Site Markers

K203097 · NEU

Devicor Medical Products, Inc.

General & Plastic Surgery · 63d

Cleared Dec 16, 2020

Arthrex DynaNite Nitinol Staples

K203180 · JDR

Arthrex, Inc.

Orthopedic · 51d

Cleared Dec 16, 2020

Longeviti ClearFit Cranial Implant

K203349 · GXN

Longeviti Neuro Solutions, LLC

Neurology · 33d

Cleared Dec 16, 2020

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP...

K203414 · HRS

DePuy Synthes

Orthopedic · 27d

Cleared Dec 15, 2020

Fixone All Suture Anchor

K192709 · MBI

Aju Pharm Co., Ltd.

Orthopedic · 445d

Cleared Dec 15, 2020

308nm Excimer System

K200971 · FTC

Xuzhou Kernel Medical Equipment Co.,...

General & Plastic Surgery · 246d

Cleared Dec 15, 2020

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA...

K201755 · MAX

SeaSpine Orthopedics Corporation

Orthopedic · 169d

Cleared Dec 15, 2020

X-Tack Endoscopic HeliX Tacking System

K201808 · PKL

Apollo Endosurgery, Inc.

Gastroenterology & Urology · 167d

Cleared Dec 15, 2020

Lim Precision Steerable TS, Steerable Sheath, Dilator

K202226 · DYB

Keystone Heart, Ltd.

Cardiovascular · 130d

Cleared Dec 15, 2020

NEXXT MATRIXX Stand Alone ALIF System

K202230 · OVD

Nexxt Spine, LLC

Orthopedic · 130d

Cleared Dec 15, 2020

Pulsed electromagnetic field wrap

K202337 · ILX

Hi-Dow International, Inc.

Physical Medicine · 120d

Cleared Dec 15, 2020

Single-use Sterile medical laser fiber

K202601 · GEX

Realton (Suzhou) Medical Technology...

General & Plastic Surgery · 98d

Cleared Dec 15, 2020

Prefilled Syringe

K202698 · EZL

Hangzhou Primecare Medical Co., Ltd.

Gastroenterology & Urology · 90d

Cleared Dec 15, 2020

308nm Excimer UV-light Skin Therapy System

K202827 · FTC

Shenzhen Gsd Tech Co., Ltd.

General & Plastic Surgery · 82d

Cleared Dec 15, 2020

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent...

K203383 · HGX

Philips Consumer Lifestyle -...

Obstetrics & Gynecology · 28d