Product code NEU— General, Plastic Surgery

HydroMARK Breast Biopsy Site Marker

Classification name: Marker, Radiographic, Implantable
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Total cleared: 110
First cleared: 2001-05-03
Most recent: 2026-01-23

Clearances under product code NEU — page 2

101–110 of 110

K033447 — CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376Mri Devices Corp.·2004-01-28
K031938 — GEL MARK III BIOPSY SITE MARKERSenorx, Inc.·2003-09-05
K023694 — BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKERBiopsy Sciences, LLC·2003-03-17
K023450 — BIOPSY SITE TISSUE MARKER DEVICEPromex, Inc.·2002-12-19
K020276 — 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535Ethicon Endo-Surgery, Inc.·2002-04-12
K014148 — SELF-DRILLING RADIOGRAPHIC MARKERWalter Lorenz Surgical, Inc.·2002-01-17
K013413 — MICROMARK II TISSUE MARKER,MODEL C1535Ethicon Endo-Surgery, Inc.·2001-12-03
K012955 — COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKERBioform, Inc.·2001-10-22
K011856 — RADIOGRAPHIC MARKERSEncore Orthopedics, Inc.·2001-08-22
K010348 — TANTALUM BEADS - RADIOGRAPHIC MARKERBiomet, Inc.·2001-05-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.