Product code NEU— General, Plastic Surgery
HydroMARK Breast Biopsy Site Marker
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 110
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NEU
1–100 of 110- K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- K253888 — MOLLI 2 System
- K252892 — SCOUT MD Surgical Guidance System
- K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)
- K251748 — MammoSTAR Biopsy Site Identifier
- K243642 — UltraCor Twirl Breast Tissue Marker
- K233639 — SmartClip Secure Soft Tissue Marker
- K240429 — Trilogy Tissue Marker
- K234149 — MOLLI 2 System
- K240042 — MOLLI 2 System
- K241762 — OneMark
- K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- K232865 — Magseed Pro Magnetic Marker System
- K231468 — SCOUT MD Surgical Guidance System
- K230836 — SchurSign Tissue Marker
- K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
- K231579 — MOLLI 2
- K221961 — HydroMARK Plus Breast Biopsy Site Marker
- K222832 — Sentimag System
- K223107 — MOLLI 2
- K212158 — HydroMARK Breast Biopsy Site Marker
- K212882 — SCOUT BX Delivery System
- K210600 — MOLLI
- K210752 — HydroMARK Breast Biopsy Site Marker
- K201863 — Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
- K203097 — HydroMARK Breast Biopsy Site Markers
- K192771 — C4 Fiducial Marker
- K193189 — RFID Localization System
- K183503 — EasyMark Tissue Marker
- K192371 — BioZorb SP Marker
- K190932 — RFID Localization System
- K190689 — SignalMark Breast Marker
- K183400 — EnVisio Navigation Sytem
- K182082 — Tumark for Eviva, Tumark for Brevera
- K181692 — 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)
- K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K180621 — EchoMark, EchoMark LP
- K180640 — SmartClip Soft Tissue Marker
- K180443 — Tumark Vision
- K180061 — UltraCor Twirl Breast Tissue Marker
- K173587 — Magseed Magnetic Marker Systtem
- K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K170803 — HydroMARK Breast Biopsy Site Markers
- K170026 — Radiopaque Tissue Marker
- K170905 — Star Tissue Marker
- K152510 — UltraCor Twirl Breast Tissue Marker
- K161021 — HydroMARK Breast Biopsy Site Marker
- K152586 — Beacon Fine Needle Fiducial System
- K153189 — Beacon Tissue Marker (SE)
- K152070 — BioZorb LP Marker
- K151998 — TraceIT Tissue Marker - 3mL
- K143484 — BioZorb Marker
- K133697 — BREAST-MED TISSUE MARKER
- K141722 — CAREFUSION GOLD TISSUE MARKER
- K142198 — BNX Fine Needle Aspiration System
- K141356 — ECHO TIP ULTRA FIDUCIAL NEEDLE
- K140835 — GENERAL AND PLASTIC SURGERY
- K132708 — BIOMARC FIDUCIAL MARKER
- K132463 — CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
- K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
- K130763 — BEACON TISSUE MARKER
- K130537 — BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
- K121964 — MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
- K123911 — SENOMARK ULTRA BREAST TISSUE MARKER
- K121113 — BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
- K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
- K113202 — TISSUE MARKER
- K111692 — TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
- K103417 — HALIFAX BIOMEDICAL TANATLUM BEAD SET
- K102506 — MIXED MEDIA MARKER
- K102768 — SECRMARK BIOPSY SITE MARKING SYSTEM
- K102608 — SECURMARK BIOPSY SITE MARKING SYSTEM
- K093473 — KMD-MARK1 TISSUE MARKER
- K100994 — PRELOADED TISSUE MARKER DEVICE
- K093064 — TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
- K090581 — TANTALUM BEAD SET, MODEL P003175
- K090547 — ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
- K090501 — BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
- K083006 — BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
- K082278 — MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
- K081085 — STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
- K081170 — PROSTATE TISSUE MARKER
- K080698 — GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
- K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
- K072219 — CYTOPHIL TISSUE MARKER
- K072913 — SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
- K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
- K070436 — BIOMARC GOLD TISSUE MARKER
- K063238 — ULTRACLIP II WING AND ULTRACLIP II COIL
- K062528 — TISSUE SITE MARKING SYSTEM
- K063193 — MODIFICATION TO BIOMARC TISSUE MARKER
- K060769 — HYDROMARK BIOPSY SITE MARKER
- K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K050384 — KAPP BARI-RING, MODEL KS-BR-2005
- K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K050090 — GEL MARK V
- K042296 — BIOMARC PRELOADED TISSUE MARKER DEVICE
- K042341 — ULTRACLIP II US
- K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
- K040706 — GEL MARK IV
Data sourced from openFDA. This site is unofficial and independent of the FDA.