Search FDA 510(k) Database

Cleared Dec 19, 2019

Halo One Thin-Walled Guiding Sheath

K192313 · DYB

C.R. Bard, Inc.

Cardiovascular · 115d

Cleared Dec 19, 2019

ZS3 and z.one pro Ultrasound Systems

K192410 · IYN

Shenzhen Mindray Bio-Medical...

Radiology · 106d

Cleared Dec 19, 2019

Everyway OTC TENS/EMS Combination

K192589 · NUH

Everyway Medical Instruments Co.,Ltd

Neurology · 90d

Cleared Dec 19, 2019

LiteWalk

K192607 · IRP

Viasonix , Ltd.

Physical Medicine · 90d

Cleared Dec 19, 2019

Albumin BCP

K193001 · CJW

SENTINEL CH. SpA

Chemistry · 52d

Cleared Dec 19, 2019

Monopolar Cord

K193004 · GEI

New Deantronics Taiwan , Ltd.

General & Plastic Surgery · 52d

Cleared Dec 18, 2019

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

K182476 · GDW

Fengh Medical Co., Ltd.

General & Plastic Surgery · 464d

Cleared Dec 18, 2019

OMNI-STAT Vascular (Rapid)

K190012 · QSY

Medtrade Product, Ltd.

General & Plastic Surgery · 349d

Cleared Dec 18, 2019

Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway...

K190824 · CCK

Bluepoint Medical GmbH & Co. KG

Anesthesiology · 261d

Cleared Dec 18, 2019

IntraMarX Radiopaque Markers

K191087 · FFX

Anx Robotica Corp

Gastroenterology & Urology · 238d

Cleared Dec 18, 2019

BioSticker System

K191614 · DRG

Biointellisense, Inc.

Cardiovascular · 183d

Cleared Dec 18, 2019

Electronic Stethoscope

K191667 · DQD

Hefei Mintti Medical Technology Co.,...

Cardiovascular · 180d

Cleared Dec 18, 2019

Sterile Latex Powder-Free Surgical Gloves

K191898 · KGO

Modern Healthcare Corp.

General Hospital · 155d

Cleared Dec 18, 2019

Avenir Complete Hip System, Size 0 Coxa Vara

K192189 · LZO

Zimmer, Inc.

Orthopedic · 127d

Cleared Dec 18, 2019

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device

K192580 · GAM

Ethicon, Inc.

General & Plastic Surgery · 90d

Cleared Dec 18, 2019

BEACON Caresystem Model 00002144

K192584 · BZK

Mermaid Care A/S

Anesthesiology · 90d

Cleared Dec 18, 2019

Neodent Instrument Kit Cases

K192670 · KCT

Jjgc Industria E Comercio DE...

General Hospital · 84d

Cleared Dec 18, 2019

Percusys® Plus Pedicle Screw System

K192680 · NKB

Joimax GmbH

Orthopedic · 83d

Cleared Dec 17, 2019

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs...

K190725 · LZA

Riverstone Resources Sdn Bhd

General Hospital · 272d

Cleared Dec 17, 2019

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

K191758 · MMX

Argon Medical Devices, Inc.

Cardiovascular · 169d

Cleared Dec 17, 2019

InMode System with Tone Applicator

K192249 · IPF

Inmode , Ltd.

Physical Medicine · 120d

Cleared Dec 17, 2019

ILUMIEN System with AptiVue Software version D.3

K192267 · DQO

Abbott Medical

Cardiovascular · 118d

Cleared Dec 17, 2019

Precision Casting Solutions Total Hip System

K192450 · LPH

Precision Casting Solution, LLC

Orthopedic · 102d

Cleared Dec 17, 2019

CNS Envision

K192572 · OLT

Moberg Research, Inc.

Neurology · 90d