Marker, Radiographic, Implantable
FDA product code NEU · 100 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4300
- Review panel
- SU
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2001-05-03 – 2026-01-23
NEU
2026-01-23
NEU
2025-12-31
MOLLI 2 System
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NEU
2025-12-19
SCOUT MD Surgical Guidance System
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NEU
2025-12-12
VizMark Preloaded Tissue Marker Device (VM-0001)
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NEU
2025-07-23
MammoSTAR Biopsy Site Identifier
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NEU
2025-03-24
UltraCor™ Twirl™ Breast Tissue Marker
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NEU
2024-12-20
SmartClip Secure Soft Tissue Marker
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NEU
2024-11-07
Trilogy Tissue Marker
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NEU
2024-09-26
MOLLI 2 System
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NEU
2024-09-25
MOLLI 2 System
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NEU
2024-09-16
OneMark
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NEU
2024-07-10
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
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NEU
2024-06-28
Magseed Pro Magnetic Marker System
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NEU
2024-02-12
SCOUT MD Surgical Guidance System
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NEU
2024-01-23
SchurSign Tissue Marker
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NEU
2024-01-12
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))
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NEU
2023-10-26
MOLLI 2
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NEU
2023-07-13
HydroMARK Plus Breast Biopsy Site Marker
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NEU
2023-01-21
Sentimag System
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NEU
2023-01-18
MOLLI 2
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NEU
2022-04-21
HydroMARK Breast Biopsy Site Marker
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NEU
2022-04-08
SCOUT BX Delivery System
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NEU
2021-04-16
MOLLI
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NEU
2021-04-14
HydroMARK Breast Biopsy Site Marker
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NEU
2021-02-18
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
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NEU
2020-12-16
HydroMARK Breast Biopsy Site Markers
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NEU
2020-10-21
C4 Fiducial Marker
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NEU
2020-05-06
RFID Localization System
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NEU
2019-10-17
EasyMark Tissue Marker
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NEU
2019-09-26
BioZorb SP Marker
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NEU
2019-09-13
RFID Localization System
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NEU
2019-08-14
SignalMark Breast Marker
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NEU
2019-03-22
EnVisio Navigation Sytem
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NEU
2018-10-31
Tumark for Eviva, Tumark for Brevera
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NEU
2018-09-25
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
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NEU
2018-08-02
Cianna Medical SAVI Scout Reflector and SAVI Scout System
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NEU
2018-06-06
EchoMark, EchoMark LP
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NEU
2018-06-04
SmartClip Soft Tissue Marker
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NEU
2018-03-22
Tumark Vision
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NEU
2018-03-09
UltraCor Twirl Breast Tissue Marker
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NEU
2018-02-16
Magseed Magnetic Marker Systtem
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NEU
2017-10-31
Cianna Medical SAVI Scout Reflector and SAVI Scout System
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NEU
2017-06-15
HydroMARK Breast Biopsy Site Markers
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NEU
2017-06-02
Radiopaque Tissue Marker
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NEU
2017-04-27
Star Tissue Marker
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NEU
2016-05-13
UltraCor Twirl Breast Tissue Marker
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NEU
2016-05-05
HydroMARK Breast Biopsy Site Marker
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NEU
2013-12-20
BIOMARC FIDUCIAL MARKER
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NEU
2013-12-03
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
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NEU
2013-06-27
STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
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NEU
2013-05-08
BEACON TISSUE MARKER
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NEU
2013-03-29
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
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NEU
2013-01-23
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
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NEU
2013-01-10
SENOMARK ULTRA BREAST TISSUE MARKER
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NEU
2012-07-12
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
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NEU
2012-04-27
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
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NEU
2012-02-28
TISSUE MARKER
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NEU
2011-11-08
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
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NEU
2011-06-28
HALIFAX BIOMEDICAL TANATLUM BEAD SET
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NEU
2011-01-12
MIXED MEDIA MARKER
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NEU
2010-12-02
SECRMARK BIOPSY SITE MARKING SYSTEM
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NEU
2010-10-08
SECURMARK BIOPSY SITE MARKING SYSTEM
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NEU
2010-07-02
KMD-MARK1 TISSUE MARKER
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NEU
2010-04-30
PRELOADED TISSUE MARKER DEVICE
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NEU
2010-02-17
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
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NEU
2009-08-21
TANTALUM BEAD SET, MODEL P003175
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NEU
2009-03-18
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
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NEU
2009-03-05
BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
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NEU
2009-02-09
BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
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NEU
2008-12-16
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
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NEU
2008-08-01
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
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NEU
2008-05-28
PROSTATE TISSUE MARKER
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NEU
2008-03-31
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
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NEU
2008-03-19
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
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NEU
2008-01-18
CYTOPHIL TISSUE MARKER
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NEU
2008-01-04
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
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NEU
2007-11-09
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
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NEU
2007-03-16
BIOMARC GOLD TISSUE MARKER
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NEU
2007-01-30
ULTRACLIP II WING AND ULTRACLIP II COIL
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NEU
2007-01-26
TISSUE SITE MARKING SYSTEM
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NEU
2006-11-21
MODIFICATION TO BIOMARC TISSUE MARKER
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NEU
2006-07-25
HYDROMARK BIOPSY SITE MARKER
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NEU
2006-01-26
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
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NEU
2006-01-13
KAPP BARI-RING, MODEL KS-BR-2005
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NEU
2005-08-30
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
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NEU
2005-02-07
GEL MARK V
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NEU
2004-09-20
ULTRACLIP II US
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NEU
2004-09-20
BIOMARC PRELOADED TISSUE MARKER DEVICE
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NEU
2004-05-13
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
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NEU
2004-04-08
GEL MARK IV
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NEU
2004-01-28
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
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NEU
2003-09-05
GEL MARK III BIOPSY SITE MARKER
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NEU
2003-03-17
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
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NEU
2002-12-19
BIOPSY SITE TISSUE MARKER DEVICE
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NEU
2002-04-12
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
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NEU
2002-01-17
SELF-DRILLING RADIOGRAPHIC MARKER
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NEU
2001-12-03
MICROMARK II TISSUE MARKER,MODEL C1535
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NEU
2001-10-22
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
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NEU
2001-08-22
RADIOGRAPHIC MARKERS
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NEU
2001-05-03
TANTALUM BEADS - RADIOGRAPHIC MARKER
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