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

NKB 2017-05-25

SETx Pedicle Screw System

Applicant Xenco Medical, LLC

K-Number K170611

View Details →

OWN 2017-05-25

KARL STORZ ICG Imaging System

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K171238

View Details →

LDF 2017-05-25

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K-Number K171253

View Details →

PGY 2017-05-25

LCD Monitor (MD310C, MD310G, MD210G)

Applicant Benq Corporation

K-Number K170944

View Details →

NHA 2017-05-25

TruAbutment DS

Applicant Truabutment

K-Number K170259

View Details →

OOI 2017-05-25

revogene

Applicant Genepoc, Inc.

K-Number K170558

View Details →

NKB 2017-05-25

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws

Applicant Medacta International S.A.

K-Number K171170

View Details →

GEX 2017-05-25

PicoWay Laser System

Applicant Syneron Candela Corporation

K-Number K170597

View Details →

LJS 2017-05-25

CATHTONG II PICC Catheter

Applicant L&Z Us, Inc.

K-Number K170486

View Details →

NJR 2017-05-25

GenePOC GBS LB

Applicant Genepoc, Inc.

K-Number K170557

View Details →

GXD 2017-05-25

MultiGen 2 RF Generator System

Applicant Stryker Corporation

K-Number K170242

View Details →

OLO 2017-05-24

Mako Partial Knee Application

Applicant Mako Surgical Corp.

K-Number K170891

View Details →

Page 2335 of 2685

↑