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Gastroenterology, Urology

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

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RecordFirmDate
LINX REFLUX MANAGEMENT SYSTEM (P100049/S010)Torax Medical2014-07-22
COAPTITE INJECTABLE IMPLANT (P040047/S036)Merz North America, Inc.2014-07-16
INTERSTIM SYSTEM (P970004/S177)Medtronic Neuromodulation2014-07-03
INTERSTIM SYSTEM (P080025/S073)Medtronic Neuromodulation2014-07-03
SNS URINARY VERIFY SCREENING TRAILING SYSTEMS (INCLUDING TEMPORARY LEADS) (P970004/S176)Medtronic Neuromodulation2014-07-02
SNS BOWEL VERIFY SCREENING TRAILING SYSTEM (INCLUDING TEMPORATY LEADS) (P080025/S072)Medtronic Neuromodulation2014-07-02
SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S175)Medtronic Neuromodulation2014-06-27
SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S071)Medtronic Neuromodulation2014-06-27
VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL; VERIFY CONTROLLER (P080025/S070)Medtronic Neuromodulation2014-06-19
VERIFY EVALUATION SYSTEM;FOR INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S174)Medtronic Neuromodulation2014-06-19
COAPTITE INJECTABLE IMPLANT (P040047/S035)Merz North America, Inc.2014-06-19
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S050)Boston Scientific Corp2014-06-16
LINX REFLUX MANAGEMENT SYSTEM (P100049/S009)Torax Medical2014-06-11
NEUROSTIMULATOR (ENS) (P970004/S173)Medtronic Neuromodulation2014-06-10
EXTERNAL NEUROSTIMULATOR (P080025/S069)Medtronic Neuromodulation2014-06-10
SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S063)Medtronic Neuromodulation2014-06-04
SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P970004/S167)Medtronic Neuromodulation2014-06-04
DEFLUX INJECTABLE GEL (P000029/S077)Palette Life Sciences2014-05-21
SOLESTA (P100014/S012)Palette Life Sciences2014-05-12
THERAKOS CELLEX PHOTOPHERESIS KIT (P860003/S075)Therakos Development Limited2014-05-09
DEFLUX INJECTABLE GEL (P000029/S076)Palette Life Sciences2014-05-08
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S034)Coloplast Corp.2014-05-05
INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S067)Medtronic Neuromodulation2014-04-24
INTERSTIM/ INTERSTIM II SACRAL NERVE STIMULATION SYSTEM (P970004/S171)Medtronic Neuromodulation2014-04-24
MEDTRONIC INTERSTIM THERAPY SYSTEM (P080025/S046)Medtronic Neuromodulation2014-04-18
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S150)Medtronic Neuromodulation2014-04-18
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S153)Medtronic Neuromodulation2014-04-15
INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S049)Medtronic Neuromodulation2014-04-15
SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S065)Medtronic Neuromodulation2014-04-11
SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S169)Medtronic Neuromodulation2014-04-11
INTERSTIM II NEUROSTIMULATOR (P970004/S170)Medtronic Neuromodulation2014-04-10
INTERSTIM II BOWEL NEUROSTIMULATOR (P080025/S066)Medtronic Neuromodulation2014-04-10
LINX REGLUX MANAGEMENT SYSTEM (P100049/S008)Torax Medical2014-04-09
SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S064)Medtronic Neuromodulation2014-04-02
SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S168)Medtronic Neuromodulation2014-04-02
COAPTITE INJECTABLE IMPLANT (P040047/S034)Merz North America, Inc.2014-03-14
AMS 700 SERIES INFATABLE PENILE PROSTHESIS (N970012/S097)Boston Scientific Corp2014-03-06
SOLESTA (P100014/S011)Palette Life Sciences2014-02-26
COAPTITE INJECTABLE IMPLANT (P040047/S033)Merz North America, Inc.2014-02-04
PROSTALUND CORETHERM SYSTEM (P010055/S007)Prostalund AB2014-01-29
SNS URINARY EXTENSIONS AND LEADS (P970004/S166)Medtronic Neuromodulation2014-01-22
SNS BOWEL EXTENSIONS (P080025/S062)Medtronic Neuromodulation2014-01-22
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S035)Coloplast Corp.2014-01-17
SOLESTA (P100014/S009)Palette Life Sciences2014-01-14
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S098)Boston Scientific Corp2014-01-02
AMS 800 URINARY CONTROL SYSTEM (P000053/S049)Boston Scientific Corp2014-01-02
LINX REFLUX MANAGEMENT SYSTEM (P100049/S007)Torax Medical2013-12-27
COAPTITE 1.0CC (P040047/S032)Merz North America, Inc.2013-12-20
LINX REFLUX MANAGEMENT SYSTEM (P100049/S006)Torax Medical2013-12-19
COAPTITE 1.0CC (P040047/S031)Merz North America, Inc.2013-12-18
INTERSTIM (P080025/S061)Medtronic Neuromodulation2013-12-13
INTERSTIM (P970004/S165)Medtronic Neuromodulation2013-12-13
SNS URINARY EXTENSIONS, SNS URINARY LEADS (P970004/S156)Medtronic Neuromodulation2013-12-11
SNS BOWEL EXTENSIONS, SNS BOWEL LEADS (P080025/S052)Medtronic Neuromodulation2013-12-11
INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P080025/S060)Medtronic Neuromodulation2013-11-22
INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S164)Medtronic Neuromodulation2013-11-22
COAPTITE INJECTABLE IMPLANT (P040047/S030)Merz North America, Inc.2013-11-21
INTERSTIM II NEUROSTIMULATOR (P080025/S059)Medtronic Neuromodulation2013-10-30
SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S163)Medtronic Neuromodulation2013-10-30
COAPTITE INJECTABLE IMPLANT (P040047/S028)Merz North America, Inc.2013-10-24
COAPTITE INJECTABLE IMPLANT (P040047/S029)Merz North America, Inc.2013-10-24
SNS URINARY PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P970004/S160)Medtronic Neuromodulation2013-10-23
SNS BOWEL PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P080025/S056)Medtronic Neuromodulation2013-10-23
SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL (P970004/S161)Medtronic Neuromodulation2013-10-22
TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT (P970004/S155)Medtronic Neuromodulation2013-10-22
SNS BOWEL ACCESSIRUES, EXTENSION , LEADS NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY, SCREENING TRIALING SYSTEMS (P080025/S057)Medtronic Neuromodulation2013-10-22
TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT (P080025/S051)Medtronic Neuromodulation2013-10-22
DEFLUX INJECTABLE GEL (P000029/S075)Palette Life Sciences2013-10-17
INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S055)Medtronic Neuromodulation2013-10-10
INTER STIM (P970004/S162)Medtronic Neuromodulation2013-10-10
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S159)Medtronic Neuromodulation2013-10-10
INTER STIM (P080025/S058)Medtronic Neuromodulation2013-10-10
SNS URINARY EXTENSIONS, SNS URINARY LEADS (P970004/S158)Medtronic Neuromodulation2013-10-03
SNS BOWEL EXTENSIONS, SNS BOWEL LEADS (P080025/S054)Medtronic Neuromodulation2013-10-03
KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S005)KARL STORZ Endoscopy-America, Inc.2013-09-23
THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S022)Boston Scientific Corp2013-09-18
LAP-BAND ADJUSTABLE GASTRIC BAND (P000008/S027)Medtimo, Inc.2013-08-29
THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY (P860003/S074)Therakos Development Limited2013-08-28
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S011)Srs Medical2013-08-28
DURASPHERE INJECTABLE BULKING AGENT (P980053/S015)Carbon Medical Technologies, Inc.2013-08-19
AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S096)Boston Scientific Corp2013-08-14
THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S071)Therakos Development Limited2013-08-08
INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATORS (P080025/S053)Medtronic Neuromodulation2013-08-01
INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATOR (P970004/S157)Medtronic Neuromodulation2013-08-01
COAPTITE INJECTABLE IMPLANT (P040047/S027)Merz North America, Inc.2013-07-23
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S151)Medtronic Neuromodulation2013-06-17
INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S047)Medtronic Neuromodulation2013-06-17
COAPTITE INJECTABLE IMPLANT (P040047/S026)Merz North America, Inc.2013-06-07
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S033)Coloplast Corp.2013-05-31
DEFLUX INJECTABLE GEL (P000029/S074)Palette Life Sciences2013-05-22
THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY (P860003/S073)Therakos Development Limited2013-05-06
THERAKOS CELLEX PHOTOPHRESES SYSTEM (P860003/S068)Therakos Development Limited2013-05-01
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S048)Boston Scientific Corp2013-04-30
INTERSTIM II NEUROSTIMULATOR (P970004/S154)Medtronic Neuromodulation2013-04-17
INTERSTIM II NEUROSTIMULATOR (P080025/S050)Medtronic Neuromodulation2013-04-17
LINX REFLUX MANAGEMENT SYSTEM (P100049/S005)Torax Medical2013-04-17
SNS URINARY INS INTERSTIM FAMILY (P970004/S146)Medtronic Neuromodulation2013-03-27
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S030)Medtimo, Inc.2013-03-27
SNS BOWEL INS INTERSTIM FAMILY (P080025/S042)Medtronic Neuromodulation2013-03-27
DURASPHERE INECTABLE BULKING AGENT (P980053/S014)Carbon Medical Technologies, Inc.2013-03-21
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