Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

KPR 2016-11-22

Multix Fusion Max

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162971

View Details →

GEX 2016-11-22

NAVILAS Laser System

Applicant Od-Os GmbH

K-Number K162191

View Details →

DXN 2016-11-22

Arm automatic blood pressure monitor

Applicant Shenzhen Pump Medical System Co., Ltd.

K-Number K161708

View Details →

KWS 2016-11-21

AltiVate Anatomic Shoulder System

Applicant Encore Medical L.P.

K-Number K162024

View Details →

OOK 2016-11-21

ZELTIQ CoolSculpting System

Applicant Zeltiq Aesthetics, Inc.

K-Number K162050

View Details →

OWQ 2016-11-21

SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

Applicant Sterilmed, Inc.

K-Number K161700

View Details →

NHA 2016-11-21

RODO Abutment System

Applicant Rodo Medical, Inc.

K-Number K160786

View Details →

ODP 2016-11-21

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

Applicant Dio Medical Co., Ltd.

K-Number K162220

View Details →

KYF 2016-11-21

XEN Glaucoma Treatment System

Applicant Allergan, Inc.

K-Number K161457

View Details →

NHA 2016-11-21

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC

Applicant Hager& Meisinger GmbH

K-Number K160132

View Details →

LCP 2016-11-21

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

Applicant Diazyme Laboratories

K-Number K160762

View Details →

HBI 2016-11-21

OptiLux LED Illuminator

Applicant Isolux, LLC

K-Number K163185

View Details →

Page 2466 of 2685

↑