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

OAS 2016-06-20

RCT700

Applicant Ray Co., Ltd.

K-Number K160525

View Details →

FFX 2016-06-20

Lehman Manometry Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K160170

View Details →

MJN 2016-06-20

REBOA Balloon Catheter

Applicant NuMED, Inc.

K-Number K160598

View Details →

KPR 2016-06-20

RADspeed Pro

Applicant Shimadzu Corporation

K-Number K152244

View Details →

OMP 2016-06-20

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

Applicant Kci USA, Inc. (Kinetic Concepts, Inc.)

K-Number K160451

View Details →

HAE 2016-06-18

Kerrison Rongeurs

Applicant Vitalitec Medizintechnik GmbH

K-Number K152734

View Details →

KNS 2016-06-17

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Applicant Sumitomo Bakelite Co., Ltd.

K-Number K152771

View Details →

HIF 2016-06-17

S698 Symbioz flow

Applicant Sopro - Acteon Group

K-Number K153367

View Details →

JBF 2016-06-17

BinaxNOW G6PD Test

Applicant Alere Scarborough, Inc.

K-Number K161364

View Details →

LLZ 2016-06-17

Quantib Brain 1

Applicant Quantib B.V.

K-Number K153351

View Details →

PIF 2016-06-17

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

Applicant Boston Scientific Corporation

K-Number K161003

View Details →

FMF 2016-06-17

Sol-M Insulin Syringe, Sol-M TB Syringe

Applicant Sol-Millennium Medical, Inc.

K-Number K153537

View Details →

Page 2573 of 2685

↑