Atlas FDA

NEU

110 FDA 510(k) clearances · Product code

92 daysmedian time to decision
272 days90th percentile
110clearances measured

FDA profile

Official device name
Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 82 · 2022: 100 · 2023: 142 · 2024: 247 · 2025: 417 · 2026: 203
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (K253761)Devicor Medical Products, Inc.2026-01-23
MOLLI 2 System (K253888)Stryker Endoscopy2025-12-31
SCOUT MD Surgical Guidance System (K252892)Merit Medical Systems, Inc.2025-12-19
VizMark Preloaded Tissue Marker Device (VM-0001) (K251989)Breast-Med, Inc.2025-12-12
MammoSTAR Biopsy Site Identifier (K251748)Carbon Medical Technologies, Inc.2025-07-23
UltraCor™ Twirl™ Breast Tissue Marker (K243642)Bard Peripheral Vascular, Inc.2025-03-24
SmartClip Secure Soft Tissue Marker (K233639)Elucent Medical, Inc.2024-12-20
Trilogy Tissue Marker (K240429)Inrad, Inc.2024-11-07
MOLLI 2 System (K234149)Molli Surgical, Inc.2024-09-26
MOLLI 2 System (K240042)Molli Surgical, Inc.2024-09-25
OneMark (K241762)View Point Medical2024-09-16
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (K240527)Devicor Medical Products, Inc.2024-07-10
Magseed Pro Magnetic Marker System (K232865)Endomagnetics Ltd.,2024-06-28
SCOUT MD Surgical Guidance System (K231468)Merit Medical System, Inc.2024-02-12
SchurSign Tissue Marker (K230836)Surgmark GmbH2024-01-23
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) (K232615)Devicor Medical Products, Inc.2024-01-12
MOLLI 2 (K231579)Molli Surgical, Inc.2023-10-26
HydroMARK Plus Breast Biopsy Site Marker (K221961)Devicor Medical Products, Inc.2023-07-13
Sentimag System (K222832)Endomagnetics Ltd.,2023-01-21
MOLLI 2 (K223107)Molli Surgical, Inc.2023-01-18
HydroMARK Breast Biopsy Site Marker (K212158)Devicor Medical Products, Inc.2022-04-21
SCOUT BX Delivery System (K212882)Merit Medical Systems, Inc.2022-04-08
MOLLI (K210600)Molli Surgical, Inc.2021-04-16
HydroMARK Breast Biopsy Site Marker (K210752)Devicor Medical Products, Inc.2021-04-14
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape (K201863)Somatex Medical Technologies GmbH2021-02-18
HydroMARK Breast Biopsy Site Markers (K203097)Devicor Medical Products, Inc.2020-12-16
C4 Fiducial Marker (K192771)C4 Imaging, LLC2020-10-21
RFID Localization System (K193189)Health Beacons, Inc.2020-05-06
EasyMark Tissue Marker (K183503)Inrad, Inc.2019-10-17
BioZorb SP Marker (K192371)Focal Therapeutics2019-09-26
RFID Localization System (K190932)Health Beacons, Inc.2019-09-13
SignalMark Breast Marker (K190689)View Point Medical, Inc.2019-08-14
EnVisio Navigation Sytem (K183400)Elucent Medical, Inc.2019-03-22
Tumark for Eviva, Tumark for Brevera (K182082)Somatex Medical Technologies GmbH2018-10-31
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) (K181692)Health Beacons, Inc.2018-09-25
Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007)Cianna Medical, Inc.2018-08-02
EchoMark, EchoMark LP (K180621)Sonavex, Inc.2018-06-06
SmartClip Soft Tissue Marker (K180640)Elucent Medical, Inc.2018-06-04
Tumark Vision (K180443)Somatex Medical Technologies GmbH2018-03-22
UltraCor Twirl Breast Tissue Marker (K180061)Bard Peripheral Vascular, Inc.2018-03-09
Magseed Magnetic Marker Systtem (K173587)Endomagnetics Ltd.,2018-02-16
Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767)Cianna Medical, Inc.2017-10-31
HydroMARK Breast Biopsy Site Markers (K170803)Devicor Medical Products, Inc.2017-06-15
Radiopaque Tissue Marker (K170026)Viscus Biologics, LLC2017-06-02
Star Tissue Marker (K170905)Scion Medical Technologies, LLC2017-04-27
UltraCor Twirl Breast Tissue Marker (K152510)Bard Peripheral Vascular, Inc.2016-05-13
HydroMARK Breast Biopsy Site Marker (K161021)Devicor Medical Products, Inc.2016-05-05
Beacon Fine Needle Fiducial System (K152586)Covidien, LLC2015-12-30
Beacon Tissue Marker (SE) (K153189)Scion Medical Technologies, LLC2015-12-17
BioZorb LP Marker (K152070)Focal Therapeutics2015-08-26
TraceIT Tissue Marker - 3mL (K151998)Augmenix, Inc.2015-08-19
BioZorb Marker (K143484)Focal Therapeutics2015-06-29
BREAST-MED TISSUE MARKER (K133697)Breast-Med, Inc.2015-04-10
CAREFUSION GOLD TISSUE MARKER (K141722)Care Fusion2015-01-23
BNX Fine Needle Aspiration System (K142198)Covidien, LLC2014-10-08
ECHO TIP ULTRA FIDUCIAL NEEDLE (K141356)Wilson-Cook Medical, Inc.2014-06-20
GENERAL AND PLASTIC SURGERY (K140835)Scion Medical Technologies, LLC2014-05-20
BIOMARC FIDUCIAL MARKER (K132708)Carbon Medical Technologies, Inc.2013-12-20
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM (K132463)Cianna Medical, Inc.2013-12-03
STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER (K131654)Senorx, Inc.2013-06-27
BEACON TISSUE MARKER (K130763)Scion Medical Technologies, LLC2013-05-08
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER (K130537)Biopsy Sciences, LLC2013-03-29
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML (K121964)Augmenix, Inc.2013-01-23
SENOMARK ULTRA BREAST TISSUE MARKER (K123911)C.R. Bard, Inc.2013-01-10
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER (K121113)Biopsy Sciences, LLC2012-07-12
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (K111895)Wilson-Cook Medical Inc./Cook Endoscopy2012-04-27
TISSUE MARKER (K113202)Focal Therapeutics2012-02-28
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC (K111692)Somatex Medical Technologies GmbH2011-11-08
HALIFAX BIOMEDICAL TANATLUM BEAD SET (K103417)Halifax Biomedical, Inc.2011-06-28
MIXED MEDIA MARKER (K102506)Cortex Manufacturing, Inc.2011-01-12
SECRMARK BIOPSY SITE MARKING SYSTEM (K102768)Hologic, Inc.2010-12-02
SECURMARK BIOPSY SITE MARKING SYSTEM (K102608)Suros Surgical Systems, Inc. A Hologic Company2010-10-08
KMD-MARK1 TISSUE MARKER (K093473)Kent Medical Devices, Inc.2010-07-02
PRELOADED TISSUE MARKER DEVICE (K100994)Carbon Medical Technologies, Inc.2010-04-30
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 (K093064)Somatex Medical Technologies GmbH2010-02-17
TANTALUM BEAD SET, MODEL P003175 (K090581)Halifax Biomedical, Inc.2009-08-21
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U (K090547)C.R. Bard, Inc.2009-03-18
BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 (K090501)Biopsy Sciences, LLC2009-03-05
BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER (K083006)Biopsy Sciences, LLC2009-02-09
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS (K082278)Ethicon Endo-Sugery, LLC2008-12-16
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS (K081085)Senorx, Inc.2008-08-01
PROSTATE TISSUE MARKER (K081170)Senorx, Inc.2008-05-28
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP (K080698)Senorx, Inc.2008-03-31
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 (K073095)Somatex Medical Technologies GmbH2008-03-19
CYTOPHIL TISSUE MARKER (K072219)Cytophil, Inc.2008-01-18
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM (K072913)Suros Surgical Systems, Inc. A Hologic Company2008-01-04
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (K072216)Kapp Surgical Instrument, Inc.2007-11-09
BIOMARC GOLD TISSUE MARKER (K070436)Carbon Medical Technologies, Inc.2007-03-16
ULTRACLIP II WING AND ULTRACLIP II COIL (K063238)Inrad2007-01-30
TISSUE SITE MARKING SYSTEM (K062528)Suros Surgical Systems, Inc.2007-01-26
MODIFICATION TO BIOMARC TISSUE MARKER (K063193)Carbon Medical Technologies, Inc.2006-11-21
HYDROMARK BIOPSY SITE MARKER (K060769)Biopsy Sciences, LLC2006-07-25
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (K053518)Medical Device Technologies, Inc.2006-01-26
KAPP BARI-RING, MODEL KS-BR-2005 (K050384)Kapp Surgical Instrument, Inc.2006-01-13
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (K051421)Medical Device Technologies, Inc.2005-08-30
GEL MARK V (K050090)Senorx, Inc.2005-02-07
ULTRACLIP II US (K042341)Inrad2004-09-20
BIOMARC PRELOADED TISSUE MARKER DEVICE (K042296)Carbon Medical Technologies, Inc.2004-09-20
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (K040990)Walter Lorenz Surgical, Inc.2004-05-13
GEL MARK IV (K040706)Senorx, Inc.2004-04-08
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