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Gastroenterology, Urology

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

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RecordFirmDate
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S040)Boston Scientific Corp2012-03-09
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S065)Therakos Development Limited2012-03-02
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S024)Coloplast Corp.2012-02-13
MODEL 3058 INTERSTIM II NEUROSTIMULATOR (P080025/S022)Medtronic Neuromodulation2012-02-10
UROLOGIX TARGIS SYSTEM (P970008/S060)Urologix, LLC2012-02-03
INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P970004/S129)Medtronic Neuromodulation2012-01-31
INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S026)Medtronic Neuromodulation2012-01-30
INTERSTIM II NEUROSTIMULATOR (P080025/S025)Medtronic Neuromodulation2012-01-20
INTERSTIM NEUROSTIMULATOR (P970004/S128)Medtronic Neuromodulation2012-01-20
INTERSTIM LEADS (P080025/S024)Medtronic Neuromodulation2012-01-13
INTERSTIM LEADS (P970004/S127)Medtronic Neuromodulation2012-01-13
HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S014)B. Braun Avitum AG2012-01-13
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S063)Therakos Development Limited2012-01-10
INTERSTIM II (P080025/S023)Medtronic Neuromodulation2011-12-28
INTERSTIM II (P970004/S126)Medtronic Neuromodulation2011-12-28
AMS UROLUME ENDOPROSTHESIS (P920023/S030)Boston Scientific Corp2011-12-14
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S026)Medtimo, Inc.2011-12-09
UROLOGIX TARGIS SYSTEM (P970008/S058)Urologix, LLC2011-12-09
REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER (P070009/S014)Obtech Medical GmbH2011-12-02
AMS UROLUME ENDOPROSTHESIS (P920023/S023)Boston Scientific Corp2011-11-23
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S022)Medtimo, Inc.2011-11-18
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S027)Coloplast Corp.2011-11-16
INTERSTIM II INS (P080025/S004)Medtronic Neuromodulation2011-11-09
INTERSTIM II INS (P970004/S112)Medtronic Neuromodulation2011-11-09
PLASMAFLO OP-05W (A) (P820033/S008)Asahi Kasei Medical Co., Ltd.2011-11-02
THERAKOS CELLEX PHOTOPHERESIS SYSTEMS (P860003/S062)Therakos Development Limited2011-10-28
SOLESTA (P100014/S004)Palette Life Sciences2011-10-27
TARGIS SYSTEM (P970008/S059)Urologix, LLC2011-10-26
AMS 800 URINARY CONTROL SYSTEM (P000053/S039)Boston Scientific Corp2011-10-26
ACTICON NEOSPHINCTER (P010020/S021)Boston Scientific Corp2011-10-26
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S089)Boston Scientific Corp2011-10-26
INTERSTIM SACRAL NERVE STIMULATION THERAPY FOR BOWEL CONTROL (P080025/S021)Medtronic Neuromodulation2011-10-11
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S026)Coloplast Corp.2011-09-26
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S061)Therakos Development Limited2011-09-22
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S038)Boston Scientific Corp2011-09-20
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S088)Boston Scientific Corp2011-09-20
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S019)Medtimo, Inc.2011-09-16
SOLESTA INJECTABLE GEL (P100014/S003)Palette Life Sciences2011-09-09
DEFLUX INJECTABLE GEL (P000029/S070)Palette Life Sciences2011-09-09
MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM (P080025/S020)Medtronic Neuromodulation2011-09-06
MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR (P080025/S019)Medtronic Neuromodulation2011-08-30
INTERSTIM THERAPY SYSTEMS (P970004/S125)Medtronic Neuromodulation2011-08-26
MEDTRONIC INTERSTIM THERAPY SYSTEM (P080025/S018)Medtronic Neuromodulation2011-08-26
INTERSTIM SYSTEM (P080025/S013)Medtronic Neuromodulation2011-08-25
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S087)Boston Scientific Corp2011-08-25
INTERSTIM SYSTEM (P970004/S121)Medtronic Neuromodulation2011-08-25
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P080025/S017)Medtronic Neuromodulation2011-08-24
INTERSTIM II, MODEL 3058 NEUROSTIMULATOR (P970004/S108)Medtronic Neuromodulation2011-08-19
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S025)Coloplast Corp.2011-08-18
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S015)Medtronic Neuromodulation2011-08-17
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S014)Medtronic Neuromodulation2011-08-17
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S122)Medtronic Neuromodulation2011-08-17
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S123)Medtronic Neuromodulation2011-08-17
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S023)Medtimo, Inc.2011-08-15
SOLESTA INJECTABLE GEL (P100014/S002)Palette Life Sciences2011-08-10
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S060)Therakos Development Limited2011-08-05
INTERSTIM FAMILY OF INS/LEADS/EXTENSION (P970004/S120)Medtronic Neuromodulation2011-08-05
INTERSTIM FAMILY OF INS/LEAD/EXTENSION (P080025/S012)Medtronic Neuromodulation2011-08-05
INTERSTIM FAMILY OF INS/LEAD/EXTENSION (P080025/S011)Medtronic Neuromodulation2011-07-29
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S024)Medtimo, Inc.2011-07-29
INTERSTIM FAMILY OF INS/LEADS/EXTENSION (P970004/S119)Medtronic Neuromodulation2011-07-29
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S057)Therakos Development Limited2011-07-29
DEFLUX INJECTABLE GEL (P000029/S069)Palette Life Sciences2011-07-28
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S010)Srs Medical2011-07-28
REALIZE ADJUSTABLE GASTRIC BAND (P070009/S011)Obtech Medical GmbH2011-07-15
COAPTITE INJECTABLE IMPLANT (P040047/S020)Merz North America, Inc.2011-07-08
INTERSTIM FAMILY OF INS/LEAD/EXTENSION (P080025/S010)Medtronic Neuromodulation2011-07-07
INTERSTIM FAMILY OF INS/LEADS/EXTENSION (P970004/S118)Medtronic Neuromodulation2011-07-07
INTERSTIM II NEUROSTIMULATORS (P970004/S117)Medtronic Neuromodulation2011-07-06
INTERSTIM II NEUROSTIMULATORS (P080025/S009)Medtronic Neuromodulation2011-07-06
AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S037)Boston Scientific Corp2011-06-24
INTERSTIM FAMILY (P970004/S115)Medtronic Neuromodulation2011-06-22
INTERSTIM FAMILY (P080025/S007)Medtronic Neuromodulation2011-06-22
PRISMAFLEX TPE 2000 SET (P830063/S006)Vantive US Healthcare, LLC2011-06-17
INTERSTIM/INTERSTIM II INS (P970004/S114)Medtronic Neuromodulation2011-06-17
INTERSTIM/INTERSTIM II INS (P080025/S006)Medtronic Neuromodulation2011-06-17
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS (P970004/S113)Medtronic Neuromodulation2011-06-16
INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS (P080025/S005)Medtronic Neuromodulation2011-06-16
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S009)Srs Medical2011-06-14
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S036)Boston Scientific Corp2011-06-13
INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P080025/S008)Medtronic Neuromodulation2011-06-10
MODEL 3058 INTERSTIM 2 NEUROSTIMULATOR (P970004/S087)Medtronic Neuromodulation2011-06-09
INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S116)Medtronic Neuromodulation2011-06-08
MACROPLASTIQUE IMPLANTS (P040050/S008)Uroplasty, LLC2011-05-27
SOLESTA INJECTABLE GEL (P100014)Palette Life Sciences2011-05-27
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S023)Coloplast Corp.2011-05-25
PROLIEVE THERMODILITATION SYSTEM (P030006/S024)Medifocus, Inc.2011-05-13
THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S059)Therakos Development Limited2011-05-13
INTERSTIM II INS (P970004/S109)Medtronic Neuromodulation2011-05-06
INTERSTIM II INS (P080025/S001)Medtronic Neuromodulation2011-05-06
3058 INTERSTIM II INS (P970004/S111)Medtronic Neuromodulation2011-05-06
3058 INTERSTIM II INS (P080025/S003)Medtronic Neuromodulation2011-05-06
INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P970004/S110)Medtronic Neuromodulation2011-05-04
INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P080025/S002)Medtronic Neuromodulation2011-05-04
UROLOGIX TARGIS SYSTEM (P970008/S056)Urologix, LLC2011-04-29
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S058)Therakos Development Limited2011-04-21
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P970004/S104)Medtronic Neuromodulation2011-04-04
REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER (P070009/S013)Obtech Medical GmbH2011-03-31
REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER (P070009/S012)Obtech Medical GmbH2011-03-31
INTERSTIM INS (P970004/S107)Medtronic Neuromodulation2011-03-17
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Every clearance here is in the API, with alerts when new ones post.