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Gastroenterology, Urology

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

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RecordFirmDate
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025)Medtronic Neuromodulation2011-03-14
INTERSTIM/INTERSTIM II INS (P970004/S106)Medtronic Neuromodulation2011-03-09
INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S105)Medtronic Neuromodulation2011-03-09
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S055)Urologix, LLC2011-03-02
LAP-BAND (P000008/S017)Medtimo, Inc.2011-02-16
MACROPLASTIQUE IMPLANTS (P040050/S007)Uroplasty, LLC2011-02-04
PLASMAFLO OP-05W (A) (P820033/S007)Asahi Kasei Medical Co., Ltd.2011-01-28
UVAR XTS PROCEDURAL KIT (P860003/S055)Therakos Development Limited2011-01-25
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S022)Coloplast Corp.2011-01-24
DURASPHERE INJECTABLE BULKING AGENT (P980053/S013)Carbon Medical Technologies, Inc.2011-01-20
INTERSTIM THERAPY SYSTEM (P970004/S098)Medtronic Neuromodulation2011-01-11
UROLOGIX TARGIS SYSTEM (P970008/S053)Urologix, LLC2011-01-07
INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT (P970004/S103)Medtronic Neuromodulation2011-01-07
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/MAGNET (P970004/S102)Medtronic Neuromodulation2011-01-05
INTERSTIM II NEUROSTIMULATOR (P970004/S101)Medtronic Neuromodulation2010-12-29
INTERSTIM INS (P970004/S100)Medtronic Neuromodulation2010-12-23
AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S085)Boston Scientific Corp2010-12-22
AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S086)Boston Scientific Corp2010-12-22
ACTICON NEOSPHINCTER (P010020/S020)Boston Scientific Corp2010-12-22
AMS 800 URINARY CONTROL SYSTEM (P000053/S034)Boston Scientific Corp2010-12-22
INTERSTIM INS (P970004/S099)Medtronic Neuromodulation2010-12-22
AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (N970012/S084)Boston Scientific Corp2010-12-16
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S033)Boston Scientific Corp2010-12-16
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S019)Boston Scientific Corp2010-12-16
ACTICON NEOSPHINCTER (P010020/S018)Boston Scientific Corp2010-12-15
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S082)Boston Scientific Corp2010-12-15
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S032)Boston Scientific Corp2010-12-15
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S021)Medtimo, Inc.2010-12-14
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S081)Boston Scientific Corp2010-12-10
CELLEX PROCEDURAL KIT (P860003/S056)Therakos Development Limited2010-12-09
AMS UROLUME ENDOPROSTHESIS (P920023/S029)Boston Scientific Corp2010-12-02
INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P970004/S097)Medtronic Neuromodulation2010-11-24
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S096)Medtronic Neuromodulation2010-11-10
TOROSA TESTICULAR PROSTHESIS (P020003/S007)Coloplast Corp.2010-11-10
INTERSTIM THERAPY/INTERSTIM II (P970004/S095)Medtronic Neuromodulation2010-11-02
DEFLUX INJECTABLE GEL (P000029/S067)Palette Life Sciences2010-10-26
INTERSTIM II IMPLANTABLE NEUROSTIMULATORS (P970004/S093)Medtronic Neuromodulation2010-10-14
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S020)Medtimo, Inc.2010-10-08
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S092)Medtronic Neuromodulation2010-10-01
AMSUROLUME ENDOPROSTHESIS (P920023/S027)Boston Scientific Corp2010-09-30
UROLUME ENDOPROSTHESIS (P920023/S028)Boston Scientific Corp2010-09-23
INTERSTIM PATIENT PROGRAMMER (P970004/S091)Medtronic Neuromodulation2010-09-10
DEFLUX INJECTABLE GEL (P000029/S066)Palette Life Sciences2010-09-03
UROLOGIX TARGIS SYSTEM (P970008/S052)Urologix, LLC2010-08-27
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S029)Boston Scientific Corp2010-08-26
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S078)Boston Scientific Corp2010-08-26
KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S001)KARL STORZ Endoscopy-America, Inc.2010-08-10
REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT (P070009/S007)Obtech Medical GmbH2010-08-10
PLASMAFLO OP-05W(A) (P820033/S006)Asahi Kasei Medical Co., Ltd.2010-08-06
REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S008)Obtech Medical GmbH2010-07-30
INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S090)Medtronic Neuromodulation2010-07-29
REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER (P070009/S010)Obtech Medical GmbH2010-07-26
H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM (P940016/S013)B. Braun Avitum AG2010-07-22
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S089)Medtronic Neuromodulation2010-07-20
UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH (P970008/S051)Urologix, LLC2010-07-16
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S021)Coloplast Corp.2010-07-14
INTERSTIM II MODEL 3058 DEVICE (P970004/S088)Medtronic Neuromodulation2010-07-14
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S017)Coloplast Corp.2010-07-02
MACROPLASTIQUE IMPLANTS (P040050/S005)Uroplasty, LLC2010-07-02
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S086)Medtronic Neuromodulation2010-06-30
BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM (P910018/S013)Kaneka Pharma America Corp.2010-06-18
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S018)Medtimo, Inc.2010-06-18
COAPTITE INJECTABLE IMPLANT (P040047/S017)Merz North America, Inc.2010-06-16
REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER (P070009/S009)Obtech Medical GmbH2010-06-04
DEFLUX INJECTABLE GEL (P000029/S065)Palette Life Sciences2010-06-01
KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027)KARL STORZ Endoscopy-America, Inc.2010-05-28
INTERSTIM ICON PATIENT PROGRAMMER (P970004/S085)Medtronic Neuromodulation2010-05-20
UROLOGIX TARGIS SYSTEM (P970008/S049)Urologix, LLC2010-05-13
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S019)Coloplast Corp.2010-05-06
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S084)Medtronic Neuromodulation2010-04-30
UROLOGIX TARGIS SYSTEM (P970008/S048)Urologix, LLC2010-04-30
AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S028)Boston Scientific Corp2010-04-23
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S015)Boston Scientific Corp2010-04-23
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD& KIT (P970004/S083)Medtronic Neuromodulation2010-04-16
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S050)Urologix, LLC2010-04-15
INTERSTIM THERAPY SYSTEM (P970004/S079)Medtronic Neuromodulation2010-04-13
INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093 (P970004/S082)Medtronic Neuromodulation2010-04-02
UROLOGIX TARGIS SYSTEM (P970008/S047)Urologix, LLC2010-03-31
DEFLUX INJECTABLE GEL (P000029/S064)Palette Life Sciences2010-03-18
PLASMAFLO OP-05W (A) (P820033/S005)Asahi Kasei Medical Co., Ltd.2010-03-16
COAPTITE INJECTABLE IMPLANT (P040047/S016)Merz North America, Inc.2010-03-11
INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY FOR URINARY CONTROL (P970004/S081)Medtronic Neuromodulation2010-03-03
INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY (P970004/S077)Medtronic Neuromodulation2010-03-03
INTERSTIM/INTERSTIM II IMPLANTABLE NEUROSTIMULATORS (P970004/S080)Medtronic Neuromodulation2010-02-26
DEFLUX INJECTABLE GEL (P000029/S063)Palette Life Sciences2010-02-23
DEFLUX INJECTABLE GEL (P000029/S062)Palette Life Sciences2010-02-23
AMS MODEL 800 ARTIFICIAL URINARY SPHINCTER (P000053/S027)Boston Scientific Corp2010-02-18
PROLIEVE THERMODILITATION SYSTEM (P030006/S023)Medifocus, Inc.2010-02-12
INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S078)Medtronic Neuromodulation2010-02-12
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S018)Coloplast Corp.2010-01-15
MEDTRONIC INTERSTIM THERAPY (P970004/S069)Medtronic Neuromodulation2010-01-14
INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S076)Medtronic Neuromodulation2010-01-13
AMS UROLUME ENDOPROSTHESIS (P920023/S026)Boston Scientific Corp2009-12-23
DEFLUX INJECTABLE GEL (P000029/S061)Palette Life Sciences2009-12-10
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S008)Srs Medical2009-12-09
DEFLUX INJECTABLE GEL (P000029/S060)Palette Life Sciences2009-11-24
PROLIEVE THERMODILITATION SYSTEM (P030006/S022)Medifocus, Inc.2009-11-23
MACROPLASTIQUE IMPLANTS (P040050/S004)Uroplasty, LLC2009-11-16
DEFLUX INJECTABLE GEL (P000029/S059)Palette Life Sciences2009-10-30
DEFLUX INJECTABLE GEL (P000029/S058)Palette Life Sciences2009-10-30
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