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

JWH 2018-03-29

Zimmer Knee Joint Replacement Prostheses MR Labeling

Applicant Zimmer, Inc.

K-Number K173057

View Details →

FGB 2018-03-29

OLYMPUS URF-P6/P6R

Applicant Olympus Medical Systems Corp.

K-Number K172298

View Details →

KOI 2018-03-29

TwitchView System

Applicant Blink Device Corporation

K-Number K172843

View Details →

IYN 2018-03-29

Voluson P6 and Voluson P8

Applicant GE Healthcare

K-Number K180535

View Details →

EOQ 2018-03-28

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

Applicant Ambu A/S

K-Number K173727

View Details →

CHH 2018-03-28

Mission Lipid Panel Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K180504

View Details →

LZO 2018-03-28

CoreHip® System

Applicant Aesculap Implants Systems, LLC

K-Number K172235

View Details →

LCX 2018-03-28

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

Applicant Runbio Biotech Co.,Ltd

K-Number K172627

View Details →

HIG 2018-03-28

GYN-Pump PH304

Applicant W.O.M. World of Medicine GmbH

K-Number K173489

View Details →

HAW 2018-03-28

ROSA BRAIN (v3.0.0.5)

Applicant Medtech S.A

K-Number K172444

View Details →

DXO 2018-03-28

PressureWire X

Applicant St. Jude Medical (Now Part of Abbott Medical)

K-Number K180558

View Details →

LQR 2018-03-28

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

Applicant Wilson-Cook Medical, Inc.

K-Number K171969

View Details →

Page 2110 of 2685

↑