FDA 510(k) Applications Submitted by DEBBIE IAMPIETRO
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K020007 |
01/02/2002 |
SAFYRE SLING SYSTEM |
PROMEDON |
K030227 |
01/22/2003 |
SUTURTEK FASTCLOSE SUTURING DEVICE |
SUTURTEK INCORPORATED |
K990572 |
02/23/1999 |
SONOTOME |
SONOKINETICS, INC. |
K020688 |
03/04/2002 |
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR |
HYDROCISION, INC. |
K010710 |
03/09/2001 |
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES |
SEEDLING ENTERPRISES. LLC. |
K020800 |
03/12/2002 |
OPTAX SYSTEM |
OPTAX SYSTEMS, INC. |
K020925 |
03/21/2002 |
CARBODISSECTING ENDOSCOPE |
ENDO SURGICAL DEVICES, INC. |
K961182 |
03/26/1996 |
3D SCOPE |
OKTAS |
K011105 |
04/11/2001 |
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE |
QRC CONSULTING |
K991383 |
04/21/1999 |
HYDROCISION DEBDRIDEMENT SYSTEM |
HYDROCISION, INC. |
K011287 |
04/27/2001 |
RADIUS COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
K961800 |
05/09/1996 |
HEAD MOUNTED DISPLAY |
VISTA MEDICAL TECHNOLOGIES, INC. |
K021641 |
05/20/2002 |
XTD THROMBECTOMY CATHETER, XX CM |
XTRAK MEDICAL INC. |
K011612 |
05/25/2001 |
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM |
HYDROCISION, INC. |
K021813 |
06/03/2002 |
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM |
HYDROCISION, INC. |
K012033 |
06/29/2001 |
MULTIFUNCTION ENDOSCOPIC INSTRUMENT |
SEEDLING ENTERPRISES. LLC. |
K022201 |
07/05/2002 |
RADIUS MICRO SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
K032127 |
07/10/2003 |
HEMEDEX FIXATION DEVICE |
HEMEDEX INCORPORATED |
K032129 |
07/10/2003 |
RADIUS 018 COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
K041941 |
07/19/2004 |
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE |
SAFE T MEDICAL DEVICES, LTD. |
K032337 |
07/29/2003 |
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 |
HEMEDEX INCORPORATED |
K022558 |
08/02/2002 |
NGT |
MEDICAL INNOVATIVE PRODUCTS |
K032468 |
08/11/2003 |
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE |
SUTURTEK INCORPORATED |
K032529 |
08/15/2003 |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 |
HYDROCISION, INC. |
K032660 |
08/28/2003 |
XTRAK SUPPORT CATHETER |
XTRAK MEDICAL INC. |
K002764 |
09/05/2000 |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR |
HYDROCISION, INC. |
K993009 |
09/07/1999 |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY |
HYDROCISION, INC. |
K032899 |
09/17/2003 |
RADIUS COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
K013376 |
10/11/2001 |
QFLOW 500 PERFUSION MONITORING SYSTEM |
HEMEDEX INCORPORATED |
K993445 |
10/12/1999 |
OMNISONIC ENDOSCOPIC DEFLECTOR |
OMNISONICS MEDICAL TECHNOLOGIES |
K013473 |
10/18/2001 |
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL |
XTRAK MEDICAL INC. |
K993628 |
10/27/1999 |
OMNISONICS ULTRASONIC PROBES |
OMNISONICS MEDICAL TECHNOLOGIES |
K013680 |
11/07/2001 |
CARBODISSECTING ENDOSCOPE |
ENDO SURGICAL DEVICES, INC. |
K033691 |
11/24/2003 |
SAFYRE VS AND SAFYRE T |
PROMEDON |
K033825 |
12/10/2003 |
ORTHOPACS |
ETRAUMA.COM CORP. |
K043522 |
12/20/2004 |
ISSYS PEDICLE SCREW SYSTEM |
CUSTOM SPINE, INC. |
|
|