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Gastroenterology, Urology

2,721 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S045)Therakos Development Limited2006-12-22
PROLIEVE THERMODILATATION SYSTEM (P030006/S012)Medifocus, Inc.2006-12-22
AMS ACTICON NEOSPHINCTER (P010020/S002)Boston Scientific Corp2006-12-21
PROSTALUND OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S003)Prostalund AB2006-12-21
TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM (P000043/S015)Boston Scientific Corp2006-12-15
THE SPANNER TEMPORARY PROSTATIC STENT (P060010)Srs Medical2006-12-14
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S006)Boston Scientific Corp2006-12-05
UROLUME URETHRAL STENT (P920023/S019)Boston Scientific Corp2006-12-05
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S003)Boston Scientific Corp2006-12-05
MACROPLASTIQUE IMPLANTS (P040050)Uroplasty, LLC2006-10-30
PROSORBA COLUMN (P850020/S024)Fresenius Hemocare, Inc.2006-10-19
THERMATRX OFFICE THERMO THERAPY (P000043/S016)Boston Scientific Corp2006-10-13
SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S005)Boston Scientific Corp2006-10-13
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S009)Allergan, Inc.2006-09-21
MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S037)Medtronic Neuromodulation2006-08-31
COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S004)Coloplast Corp.2006-08-23
PROLIEVE THERMODILATATION SYSTEM (P030006/S011)Medifocus, Inc.2006-08-10
DEFLUX INJECTABLE GEL (P000029/S018)Palette Life Sciences2006-07-27
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S044)Therakos Development Limited2006-07-14
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S033)Medtronic Neuromodulation2006-06-30
INTERSTIM FOR URINARY CONTROL (P970004/S039)Medtronic Neuromodulation2006-06-27
PROSORBA COLUMN (P850020/S022)Fresenius Hemocare, Inc.2006-06-22
BARD TEGRESS URETHRAL IMPLANT (P030030/S003)C.R. Bard, Inc.2006-05-23
PROSORBA COLUMN (P850020/S023)Fresenius Hemocare, Inc.2006-05-11
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S009)Medtimo, Inc.2006-04-24
PROLIEVE THERMODILATATION SYSTEM (P030006/S008)Medifocus, Inc.2006-03-31
THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S014)Boston Scientific Corp2006-03-28
WAVSTAT OPTICAL BIOPSY SYSTEM (P990050/S006)Spectra Science2006-03-28
UROLOGIX TARGIS SYSTEM (P970008/S029)Urologix, LLC2006-03-23
UROLOGIX TARGIS SYSTEM (P970008/S030)Urologix, LLC2006-03-20
DURASPHERE INJECTABLE BULKING AGENT (P980053/S010)Carbon Medical Technologies, Inc.2006-03-15
PROLIEVE THERMODILATATION SYSTEM (P030006/S009)Medifocus, Inc.2006-03-15
DEFLUX INJECTABLE GEL (P000029/S016)Palette Life Sciences2006-03-01
THERMATIX OFFICE THERMO THERAPY SYSTEM (P000043/S013)Boston Scientific Corp2006-02-27
INTERSTIM (P970004/S034)Medtronic Neuromodulation2006-02-21
UROLOGIX TARGIS SYSTEM (P970008/S028)Urologix, LLC2006-02-06
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S008)Medtimo, Inc.2006-02-02
PROLIEVE THERMODILATATION SYSTEM (P030006/S010)Medifocus, Inc.2006-01-20
INTERSTIM-THERAPY FOR URINARY CONTROL (P970004/S035)Medtronic Neuromodulation2005-12-23
DEFLUX (P000029/S013)Palette Life Sciences2005-12-12
COAPTITE (P040047)Merz North America, Inc.2005-11-10
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S036)Medtronic Neuromodulation2005-11-08
DEFLUX INJECTABLE GEL (P000029/S015)Palette Life Sciences2005-10-31
DEFLUX SYRINGE (P000029/S014)Palette Life Sciences2005-10-28
PROLIEVE THERMODILATATION SYSTEM (P030006/S007)Medifocus, Inc.2005-10-06
DURASPHERE INJECTABLE BULKING AGENT (P980053/S008)Carbon Medical Technologies, Inc.2005-09-26
PROSORBA COLUMN (P850020/S021)Fresenius Hemocare, Inc.2005-08-25
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S043)Therakos Development Limited2005-08-19
PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN (P850020/S020)Fresenius Hemocare, Inc.2005-08-17
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE (P970004/S029)Medtronic Neuromodulation2005-08-04
DEFLUX INJECTABLE GEL (P000029/S012)Palette Life Sciences2005-08-02
PROLIEVE THERMODILATATION SYSTEM (P030006/S006)Medifocus, Inc.2005-07-22
PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH (P010055/S001)Prostalund AB2005-07-07
PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER (P030006/S005)Medifocus, Inc.2005-06-30
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S026)Urologix, LLC2005-06-16
ENTERYX PROCEDURE KIT (P020006/S008)Boston Scientific Corp2005-06-02
BARD TEGRESS URETHRAL IMPLANT (P030030/S002)C.R. Bard, Inc.2005-05-27
INTERSTIM SYSTEM (P970004/S032)Medtronic Neuromodulation2005-05-27
UROLOGIX PROSTATRON SYSTEM (P950014/S025)Urologix, Inc.2005-05-25
DURASPHERE INJECTABLE BULKING AGENT (P980053/S009)Carbon Medical Technologies, Inc.2005-05-25
TARGIS SYSTEM (P970008/S027)Urologix, LLC2005-04-29
PROLIEVE THERMODILATATION SYSTEM (P030006/S003)Medifocus, Inc.2005-03-24
PROLIEVE THERMODILATATION SYSTEM (P030006/S004)Medifocus, Inc.2005-03-11
PROSTATRON (P950014/S024)Urologix, Inc.2005-02-23
PROSTATRON (P950014/S023)Urologix, Inc.2005-02-18
UROLOGIX TARGIS SYSTEM (P970008/S024)Urologix, LLC2005-02-18
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S025)Urologix, LLC2005-02-15
TEGRESS URETHRAL IMPLANT (P030030/S001)C.R. Bard, Inc.2005-02-09
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S005)Coloplast Corp.2005-01-12
URYX URETHRAL BULKING AGENT (P030030)C.R. Bard, Inc.2004-12-16
MEDTRONIC INTERSTIM TINED LEAD (P970004/S030)Medtronic Neuromodulation2004-11-24
DEFLUX INJECTABLE GEL (P000029/S011)Palette Life Sciences2004-11-12
CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S002)Prostalund AB2004-11-05
DEFLUX INJECTABLE GEL (P000029/S010)Palette Life Sciences2004-11-02
DURASPHERE EXP (P980053/S007)Carbon Medical Technologies, Inc.2004-10-27
TMX-2000 BPH (P000043/S009)Boston Scientific Corp2004-10-18
UROLUME ENDOPROSTHESIS (P920023/S018)Boston Scientific Corp2004-10-15
CELSION PROLIEVE THERMODILATATION SYSTEM (P030006/S002)Medifocus, Inc.2004-09-17
ENTERYX PROCEDURE KIT, MODEL M000572600 (P020006/S005)Boston Scientific Corp2004-08-20
DEFLUX INJECTABLE GEL (P000029/S009)Palette Life Sciences2004-07-30
SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S003)Coloplast Corp.2004-07-28
UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY (P920023/S015)Boston Scientific Corp2004-07-22
DEFLUX INJECTABLE GEL (P000029/S008)Palette Life Sciences2004-07-09
PROSTATRON PRAKTIS (P950014/S022)Urologix, Inc.2004-06-10
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S025)Medtronic Neuromodulation2004-06-08
MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095 (P970004/S028)Medtronic Neuromodulation2004-05-27
ENTERYX PROCEDURE KIT (P020006/S004)Boston Scientific Corp2004-05-26
AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S004)Boston Scientific Corp2004-05-07
TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S007)Boston Scientific Corp2004-04-28
MENTOR INFLATABLE PENILE PROSTHESIS (P000006/S004)Coloplast Corp.2004-04-28
DEFLUX INJECTABLE GEL (P000029/S007)Palette Life Sciences2004-04-21
PROLIEVE THERMODILATATION SYSTEM (P030006/S001)Medifocus, Inc.2004-04-15
PROSORBA COLUMN (P850020/S017)Fresenius Hemocare, Inc.2004-04-15
PROSORBA COLUMN (P850020/S019)Fresenius Hemocare, Inc.2004-04-14
AMS ACTICO N NEOSPHINCTER (P010020/S001)Boston Scientific Corp2004-03-24
AMS 800 URINARY CONTROL SYSTEM (P000053/S003)Boston Scientific Corp2004-03-24
MENTOR SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S002)Coloplast Corp.2004-03-18
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S002)Boston Scientific Corp2004-03-16
DEFLUX INJECTABLE GEL (P000029/S006)Palette Life Sciences2004-03-01
PROLIEVE THERMODILATATION SYSTEM (P030006)Medifocus, Inc.2004-02-19
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