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Gastroenterology, Urology

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

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RecordFirmDate
DEFLUX INJECTABLE GEL (P000029/S057)Palette Life Sciences2009-10-30
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S073)Medtronic Neuromodulation2009-10-26
COAPTITE INJECTABLE IMPLANT (P040047/S015)Merz North America, Inc.2009-10-22
UROLOGIX TARGIS SYSTEM (P970008/S046)Urologix, LLC2009-10-22
INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S075)Medtronic Neuromodulation2009-10-15
REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S006)Obtech Medical GmbH2009-10-06
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S011)Allergan, Inc.2009-10-02
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S054)Therakos Development Limited2009-09-15
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S015)Coloplast Corp.2009-09-11
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S045)Urologix, LLC2009-08-27
WAVSTAT OPTICAL BIOPSY SYSTEM (P990050/S007)Spectra Science2009-08-27
REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S005)Obtech Medical GmbH2009-08-25
ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S014)Boston Scientific Corp2009-08-13
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S026)Boston Scientific Corp2009-08-13
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S025)Boston Scientific Corp2009-08-05
INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S074)Medtronic Neuromodulation2009-07-10
AMS 800 URINARY CONTROL SYSTEM (P000053/S024)Boston Scientific Corp2009-07-06
MACROPLASTIQUE IMPLANTS (P040050/S003)Uroplasty, LLC2009-06-26
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S007)Srs Medical2009-06-26
COAPTITE INJECTABLE IMPLANT (P040047/S013)Merz North America, Inc.2009-06-24
UROLOGIX TARGIS SYSTEM (P970008/S044)Urologix, LLC2009-06-24
PRISMA TPE 2000 SET (P830063/S005)Vantive US Healthcare, LLC2009-06-19
PROLIEVE THERMODILITATION SYSTEM (P030006/S021)Medifocus, Inc.2009-06-19
CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S006)Prostalund AB2009-06-08
TITAN INFLATABLE PENILE PROSTHESIS (IPP) (P000006/S014)Coloplast Corp.2009-05-29
DEFLUX INJECTABLE GEL (P000029/S056)Palette Life Sciences2009-05-27
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S006)Srs Medical2009-05-27
THERAKOS CELLEX* PHOTOPHERESIS SYSTEM (P860003/S053)Therakos Development Limited2009-05-27
CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S005)Prostalund AB2009-05-21
DEFLUX INJECTABLE GEL (P000029/S050)Palette Life Sciences2009-05-21
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S005)Srs Medical2009-05-19
PROLIEVE THERMODILITATION SYSTEM (P030006/S017)Medifocus, Inc.2009-05-18
DEFLUX INJECTABLE GEL (P000029/S055)Palette Life Sciences2009-05-05
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S064)Medtronic Neuromodulation2009-04-30
INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S072)Medtronic Neuromodulation2009-04-30
PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) (P940016/S012)B. Braun Avitum AG2009-04-20
PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) (P940016/S011)B. Braun Avitum AG2009-04-20
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S004)Srs Medical2009-04-14
ACTICON ARTIFICAL BOWEL SPHINCTER (ABS) (P010020/S013)Boston Scientific Corp2009-04-08
AMS 800 ARTIFICAL URINARY SPHINCTER (AUS) (P000053/S023)Boston Scientific Corp2009-04-08
DEFLUX INJECTABLE GEL (P000029/S042)Palette Life Sciences2009-04-01
LIPOSORBER LA-15 SYSTEM (P910018/S012)Kaneka Pharma America Corp.2009-03-31
UVAR CELLEX PHOTOPHERESIS SYSTEM (P860003/S048)Therakos Development Limited2009-03-20
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S022)Boston Scientific Corp2009-03-19
AMS 800 URINARY CONTROL SYSTEM (P000053/S021)Boston Scientific Corp2009-03-19
INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S071)Medtronic Neuromodulation2009-03-12
COAPTITE INJECTABLE IMPLANT (P040047/S011)Merz North America, Inc.2009-03-11
SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE (P060010/S003)Srs Medical2009-03-10
COAPTITE INJECTABLE IMPLANT (P040047/S014)Merz North America, Inc.2009-03-06
UROLOGIX TARGIS SYSTEM (P970008/S043)Urologix, LLC2009-03-05
INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S070)Medtronic Neuromodulation2009-03-02
REALIZE ADJUSTABLE GASTRIC BAND (P070009/S004)Obtech Medical GmbH2009-02-23
AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S020)Boston Scientific Corp2009-02-13
ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S012)Boston Scientific Corp2009-02-13
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S062)Medtronic Neuromodulation2009-01-30
UROLOGIX TARGIS SYSTEM (P970008/S042)Urologix, LLC2009-01-29
INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S068)Medtronic Neuromodulation2009-01-26
INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S065)Medtronic Neuromodulation2009-01-16
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S051)Therakos Development Limited2009-01-16
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S014)Medtimo, Inc.2009-01-16
INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S066)Medtronic Neuromodulation2009-01-14
DEFLUX INJECTABLE GEL (P000029/S053)Palette Life Sciences2009-01-09
COAPTITE INJECTABLE IMPLANT (P040047/S012)Merz North America, Inc.2009-01-07
INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S067)Medtronic Neuromodulation2009-01-05
COAPTITE INJECTABLE IMPLANT (P040047/S010)Merz North America, Inc.2008-12-30
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S013)Coloplast Corp.2008-12-22
SALINE FILLED TESTICULAR PROSTHESIS (P020003/S006)Coloplast Corp.2008-12-22
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S012)Coloplast Corp.2008-12-19
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S050)Therakos Development Limited2008-12-19
DEFLUX INJECTABLE GEL (P000029/S052)Palette Life Sciences2008-12-12
UROLOGIX TARGIS SYSTEM (P970008/S041)Urologix, LLC2008-12-09
PROLIEVE THERMODILITATION SYSTEM (P030006/S020)Medifocus, Inc.2008-12-09
INTERSTIM THERAPY (P970004/S063)Medtronic Neuromodulation2008-11-25
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S013)Medtimo, Inc.2008-11-25
UROLOGIX TARGIX SYSTEM (P970008/S040)Urologix, LLC2008-11-19
COAPTITE INJECTABLE IMPLANT (P040047/S009)Merz North America, Inc.2008-11-14
DEFLUX INJECTABLE GEL (P000029/S051)Palette Life Sciences2008-10-22
INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S060)Medtronic Neuromodulation2008-10-17
PROLIEVE THERMODILITATION SYSTEM (P030006/S018)Medifocus, Inc.2008-10-16
REALIZE ADJUSTABLE GASTRIC BAND (P070009/S003)Obtech Medical GmbH2008-10-15
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S019)Boston Scientific Corp2008-10-09
ACTICON ARTIFICIAL BOWEL SPHINCTER (P010020/S011)Boston Scientific Corp2008-10-09
COAPTITE (P040047/S001)Merz North America, Inc.2008-09-29
COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S011)Coloplast Corp.2008-09-16
DEFLUX INJECTABLE GEL (P000029/S049)Palette Life Sciences2008-09-11
SWEDISH ADJUSTABLE GASTRIC BAND (P070009/S001)Obtech Medical GmbH2008-09-09
UROLOGIX TARGIS SYSTEM (P970008/S038)Urologix, LLC2008-09-02
COAPTITE INJECTABLE IMPLANT (P040047/S008)Merz North America, Inc.2008-09-02
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S049)Therakos Development Limited2008-08-29
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S012)Medtimo, Inc.2008-08-26
COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S010)Coloplast Corp.2008-08-22
INTERSTIM II NEUROSTIMULATOR (P970004/S050)Medtronic Neuromodulation2008-08-18
PROLIEVE THERMODILITATION SYSTEM (P030006/S019)Medifocus, Inc.2008-08-13
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S010)Boston Scientific Corp2008-08-08
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S017)Boston Scientific Corp2008-08-08
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S018)Boston Scientific Corp2008-07-31
COAPTITE INJECTABLE IMPLANT (P040047/S006)Merz North America, Inc.2008-07-30
COAPTITE INJECTABLE IMPLANT (P040047/S007)Merz North America, Inc.2008-07-24
DEFLUX INJECTABLE GEL (P000029/S021)Palette Life Sciences2008-07-21
UROLOGIX PROSTATRON SYSTEM (P950014/S026)Urologix, Inc.2008-07-16
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