Search FDA 510(k) Database

Cleared Mar 16, 2020

Sunmed Disposable Angio-Closure Pads

K191827 · DXC

Sunny Medical Device (Shenzhen) Co.,...

Cardiovascular · 252d

Cleared Mar 16, 2020

Altera Filter and HME/Filter

K192713 · CAH

Meditera Tibbi Malzeme San VE Tic AS

General Hospital · 171d

Cleared Mar 16, 2020

Al-Rad Companion (Musculoskeletal)

K193267 · JAK

Siemens Medical Solutions USA, Inc.

Radiology · 111d

Cleared Mar 16, 2020

Epic 980

K193486 · GEX

Biolase, Inc.

General & Plastic Surgery · 90d

Cleared Mar 16, 2020

Response BandLoc Spinal Fixation

K200097 · OWI

OrthoPediatrics Corp.

Orthopedic · 60d

Cleared Mar 16, 2020

SANDRO Dual

K200110 · GEX

Wontech Co., Ltd.

General & Plastic Surgery · 59d

Cleared Mar 16, 2020

CONTINUUM PACS

K200385 · NFJ

Integrated Ophthalmic Systems, Inc.

Ophthalmic · 27d

Cleared Mar 16, 2020

AERO CHROME* Breathable Performance Surgical Gowns

K200522 · FYA

O&M Halyard, Inc.

General Hospital · 14d

Cleared Mar 14, 2020

Health Expert Electronic Stimulator (model: AST-300L)

K190783 · NUH

Shenzhen Osto Technology Company Limited

Neurology · 353d

Cleared Mar 13, 2020

Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...

K191869 · KGO

Molnlycke Health Care Us, LLC

General Hospital · 245d

Cleared Mar 13, 2020

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC...

K192162 · GXR

Neurovention, LLC

Neurology · 217d

Cleared Mar 13, 2020

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free...

K192241 · LZA

O&M Haylard, Inc.

General Hospital · 207d

Cleared Mar 13, 2020

MeDioStar

K192483 · GEX

Asclepion Laser Technologies GmbH

General & Plastic Surgery · 185d

Cleared Mar 13, 2020

GIA Stapler with Tri-Staple Technology

K192720 · GDW

Covidien

General & Plastic Surgery · 168d

Cleared Mar 13, 2020

Curian HpSA, Curian Analyzer

K192817 · LYR

Meridian Bioscience, Inc.

Microbiology · 164d

Cleared Mar 13, 2020

EzOrtho

K192888 · LLZ

Ewoosoft Co., Ltd.

Radiology · 155d

Cleared Mar 13, 2020

32HL512D

K192925 · PGY

Lg Electronics.Inc

Radiology · 149d

Cleared Mar 13, 2020

iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair...

K193105 · JWH

Conformis, Inc.

Orthopedic · 126d

Cleared Mar 13, 2020

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

K193110 · QKM

3M Healthcare

General Hospital · 122d

Cleared Mar 13, 2020

Indigo Aspiration System – Lightning Aspiration Tubing

K193244 · QEW

Penumbra, Inc.

Cardiovascular · 109d

Cleared Mar 13, 2020

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System...

K193325 · KNT

Prosys International, Ltd.

Gastroenterology & Urology · 102d

Cleared Mar 13, 2020

SeaSpine Skipjack System

K193418 · MAX

SeaSpine Orthopedics Corporation

Orthopedic · 95d

Cleared Mar 13, 2020

PrisMax System Version 3

K193482 · KDI

Baxter Healthcare Corporation

Gastroenterology & Urology · 87d

Cleared Mar 13, 2020

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

K193572 · LON

bioMerieux, Inc.

Microbiology · 81d