Panels › General, Plastic Surgery › Product code NEU · Class 2
Marker, Radiographic, Implantable
Regulation 878.4300
4510(k)s in 12 months (110 all time)
3recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in NEU
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2015 | K151998 | TraceIT Tissue Marker - 3mL Augmenix, Inc. | NEU |
| Jun 29, 2015 | K143484 | BioZorb Marker Focal Therapeutics | NEU |
| Apr 10, 2015 | K133697 | BREAST-MED TISSUE MARKER Breast-Med, Inc. | NEU |
| Jan 23, 2015 | K141722 | CAREFUSION GOLD TISSUE MARKER Care Fusion | NEU |
| Oct 8, 2014 | K142198 | BNX Fine Needle Aspiration System Covidien, LLC | NEU |
| Jun 20, 2014 | K141356 | ECHO TIP ULTRA FIDUCIAL NEEDLE Wilson-Cook Medical, Inc. | NEU |
| May 20, 2014 | K140835 | GENERAL AND PLASTIC SURGERY Scion Medical Technologies, LLC | NEU |
| Dec 20, 2013 | K132708 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. | NEU |
| Dec 3, 2013 | K132463 | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM Cianna Medical, Inc. | NEU |
| Jun 27, 2013 | K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER Senorx, Inc. | NEU |
| May 8, 2013 | K130763 | BEACON TISSUE MARKER Scion Medical Technologies, LLC | NEU |
| Mar 29, 2013 | K130537 | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Jan 23, 2013 | K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML Augmenix, Inc. | NEU |
| Jan 10, 2013 | K123911 | SENOMARK ULTRA BREAST TISSUE MARKER C.R. Bard, Inc. | NEU |
| Jul 12, 2012 | K121113 | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Apr 27, 2012 | K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE Wilson-Cook Medical Inc./Cook Endoscopy | NEU |
| Feb 28, 2012 | K113202 | TISSUE MARKER Focal Therapeutics | NEU |
| Nov 8, 2011 | K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC Somatex Medical Technologies GmbH, DE | NEU |
| Jun 28, 2011 | K103417 | HALIFAX BIOMEDICAL TANATLUM BEAD SET Halifax Biomedical, Inc. | NEU |
| Jan 12, 2011 | K102506 | MIXED MEDIA MARKER Cortex Manufacturing, Inc. | NEU |
| Dec 2, 2010 | K102768 | SECRMARK BIOPSY SITE MARKING SYSTEM Hologic, Inc. | NEU |
| Oct 8, 2010 | K102608 | SECURMARK BIOPSY SITE MARKING SYSTEM Suros Surgical Systems, Inc. A Hologic Company | NEU |
| Jul 2, 2010 | K093473 | KMD-MARK1 TISSUE MARKER Kent Medical Devices, Inc. | NEU |
| Apr 30, 2010 | K100994 | PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. | NEU |
| Feb 17, 2010 | K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 Somatex Medical Technologies GmbH | NEU |
| Aug 21, 2009 | K090581 | TANTALUM BEAD SET, MODEL P003175 Halifax Biomedical, Inc., CA | NEU |
| Mar 18, 2009 | K090547 | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U C.R. Bard, Inc. | NEU |
| Mar 5, 2009 | 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 Biopsy Sciences, LLC | NEU |
| Feb 9, 2009 | K083006 | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Dec 16, 2008 | K082278 | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS Ethicon Endo-Sugery, LLC | NEU |
| Aug 1, 2008 | K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS Senorx, Inc. | NEU |
| May 28, 2008 | K081170 | PROSTATE TISSUE MARKER Senorx, Inc. | NEU |
| Mar 31, 2008 | K080698 | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP Senorx, Inc. | NEU |
| Mar 19, 2008 | K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 Somatex Medical Technologies GmbH | NEU |
| Jan 18, 2008 | K072219 | CYTOPHIL TISSUE MARKER Cytophil, Inc. | NEU |
| Jan 4, 2008 | K072913 | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM Suros Surgical Systems, Inc. A Hologic Company | NEU |
| Nov 9, 2007 | K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 Kapp Surgical Instrument, Inc. | NEU |
| Mar 16, 2007 | K070436 | BIOMARC GOLD TISSUE MARKER Carbon Medical Technologies, Inc. | NEU |
| Jan 30, 2007 | K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL Inrad | NEU |
| Jan 26, 2007 | K062528 | TISSUE SITE MARKING SYSTEM Suros Surgical Systems, Inc. | NEU |
| Nov 21, 2006 | K063193 | MODIFICATION TO BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. | NEU |
| Jul 25, 2006 | K060769 | HYDROMARK BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Jan 26, 2006 | K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR Medical Device Technologies, Inc. | NEU |
| Jan 13, 2006 | K050384 | KAPP BARI-RING, MODEL KS-BR-2005 Kapp Surgical Instrument, Inc. | NEU |
| Aug 30, 2005 | K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR Medical Device Technologies, Inc. | NEU |
| Feb 7, 2005 | K050090 | GEL MARK V Senorx, Inc. | NEU |
| Sep 20, 2004 | K042341 | ULTRACLIP II US Inrad | NEU |
| Sep 20, 2004 | K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. | NEU |
| May 13, 2004 | K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS Walter Lorenz Surgical, Inc. | NEU |
| Apr 8, 2004 | K040706 | GEL MARK IV Senorx, Inc. | NEU |
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