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

Company	510(k)s	Recalls
Devicor Medical Products, Inc.	9	2
Carbon Medical Technologies, Inc.	6	1
Senorx, Inc.	7	0
Somatex Medical Technologies GmbH	6	1
Biopsy Sciences, LLC	6	0
Bard Peripheral Vascular, Inc.	3	2
Endomagnetics Ltd.,	3	2
Molli Surgical, Inc.	5	0
Elucent Medical, Inc.	3	1
Focal Therapeutics	4	0

Decided	510(k)	Device and applicant	Code
Jan 28, 2004	K033447	CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 Mri Devices Corp.	NEU
Sep 5, 2003	K031938	GEL MARK III BIOPSY SITE MARKER Senorx, Inc.	NEU
Mar 17, 2003	K023694	BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER Biopsy Sciences, LLC	NEU
Dec 19, 2002	K023450	BIOPSY SITE TISSUE MARKER DEVICE Promex, Inc.	NEU
Apr 12, 2002	K020276	8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 Ethicon Endo-Surgery, Inc.	NEU
Jan 17, 2002	K014148	SELF-DRILLING RADIOGRAPHIC MARKER Walter Lorenz Surgical, Inc.	NEU
Dec 3, 2001	K013413	MICROMARK II TISSUE MARKER,MODEL C1535 Ethicon Endo-Surgery, Inc.	NEU
Oct 22, 2001	K012955	COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER Bioform, Inc.	NEU
Aug 22, 2001	K011856	RADIOGRAPHIC MARKERS Encore Orthopedics, Inc.	NEU
May 3, 2001	K010348	TANTALUM BEADS - RADIOGRAPHIC MARKER Biomet, Inc.	NEU

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