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Gastroenterology, Urology

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

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RecordFirmDate
KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S008)KARL STORZ Endoscopy-America, Inc.2017-03-17
Obalon Balloon Sustem (P160001/S005)Medtimo, Inc.2017-03-09
AMS 700 Implantable Penile Prosthesis (N970012/S130)Boston Scientific Corp2017-02-23
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S008)Boston Scientific Corporation2017-02-21
AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S121)Boston Scientific Corp2017-02-10
MEDTRONIC INTERSTIM THERAPY SYSTEM SNS BOWEL LEADS (P080025/S132)Medtronic Neuromodulation2017-02-06
MEDTRONIC INTERSTIM THERAPY SYSTEM DBS LEADS (P970004/S237)Medtronic Neuromodulation2017-02-06
MEDTRONIC INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S236)Medtronic Neuromodulation2017-01-26
SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P970004/S235)Medtronic Neuromodulation2017-01-26
MEDTRONIC INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S131)Medtronic Neuromodulation2017-01-26
SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P080025/S130)Medtronic Neuromodulation2017-01-26
DEFLUX INJECTABLE GEL (P000029/S082)Palette Life Sciences2017-01-18
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S129)Medtronic Neuromodulation2017-01-18
SOLESTA INJECTABLE GEL (P100014/S019)Palette Life Sciences2017-01-18
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY INCONTINENCE (P970004/S234)Medtronic Neuromodulation2017-01-18
LINX REFLUX MANAGEMENT SYSTEM (P100049/S019)Torax Medical2017-01-12
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S006)Boston Scientific Corporation2017-01-06
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S007)Boston Scientific Corporation2017-01-06
AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S125)Boston Scientific Corp2016-12-22
PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N (P830063/S009)Vantive US Healthcare, LLC2016-12-22
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S074)Boston Scientific Corp2016-12-22
MAESTRO RECHARGEABLE SYSTEM (P130019/S012)Reshape Lifesciences, Inc.2016-12-22
INTERSTIM THERAPY SYSTEM (P970004/S233)Medtronic Neuromodulation2016-12-22
INTERSTIM THERAPY SYSTEM (P080025/S128)Medtronic Neuromodulation2016-12-22
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) AND AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S123)Boston Scientific Corp2016-12-21
AMS 700 INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE TREATMENT (N970012/S122)Boston Scientific Corp2016-12-19
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S072)Boston Scientific Corp2016-12-19
INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S127)Medtronic Neuromodulation2016-12-15
AspireAssist (P150024/S005)Aspire Bariatrics, Inc.2016-12-15
InterStim Therapy System (URINARY) (P970004/S232)Medtronic Neuromodulation2016-12-15
OBALON BALLOON SYSTEM (P160001/S002)Medtimo, Inc.2016-12-15
AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S069)Boston Scientific Corp2016-12-14
AMS 700 Inflatable Penile Prosthesis (IPP)with and without InhibiZone Treatment and AMS Ambicor Inflatable Penile Prosth (N970012/S119)Boston Scientific Corp2016-12-14
SNS Urinary Accessories SNS Urinary Extensions SNS Urinary Leads SNS Urinary Neurostimulator 3023,3058 SNS Urinary Progr (P970004/S231)Medtronic Neuromodulation2016-12-13
SNS Bowel Accessories SNS Bowel Extensions SNS Bowel LeadsSNS Bowel Neurostimulators SNS Bowel Programming SNS Bowel Scr (P080025/S126)Medtronic Neuromodulation2016-12-13
AMS 800 URINARY CONTROL SYSTEMS, AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S067)Boston Scientific Corp2016-12-09
AMS 700 INFLATABLE PENILE PROSTHESES WITH INHIBIIZONE TREATMENT; AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S118)Boston Scientific Corp2016-12-09
LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT, LEADS (P970004/S152)Medtronic Neuromodulation2016-12-06
LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT AND LEAD (P080025/S048)Medtronic Neuromodulation2016-12-06
AMS 700 SERIES INFLATABLE PENILE PROSTHESES (N970012/S124)Boston Scientific Corp2016-12-01
AMS 800 URINARY CONTROL SYSTEM (P000053/S073)Boston Scientific Corp2016-12-01
AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT (N970012/S120)Boston Scientific Corp2016-11-29
INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL) (P970004/S228)Medtronic Neuromodulation2016-11-23
INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL) (P080025/S123)Medtronic Neuromodulation2016-11-23
AMS SPHINCTER 800 URINARY CONTROL SYSTEM WITH AND WITHOUT INHIBIZONE TREATMENT (P000053/S071)Boston Scientific Corp2016-11-22
MAESTRO RECHARGEABLE SYSTEM (P130019/S011)Reshape Lifesciences, Inc.2016-11-21
INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S125)Medtronic Neuromodulation2016-11-17
INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S230)Medtronic Neuromodulation2016-11-17
H.E.L.P. Futura Apheresis System (P940016/S022)B. Braun Avitum AG2016-11-15
INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL) (P080025/S120)Medtronic Neuromodulation2016-11-10
INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL) (P970004/S225)Medtronic Neuromodulation2016-11-10
AspireAssist (P150024/S004)Aspire Bariatrics, Inc.2016-11-04
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (P130018/S001)Uromedica, Inc.2016-11-02
AMS 800 URINARY CONTROL SYSTEMS & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S070)Boston Scientific Corp2016-11-01
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S005)Boston Scientific Corporation2016-10-25
INTERSTIM THERAPY SYSTEM FOR BOWEL CONTROL (P080025/S124)Medtronic Neuromodulation2016-10-24
INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S229)Medtronic Neuromodulation2016-10-24
AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S068)Boston Scientific Corp2016-10-21
LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL (P100049/S018)Torax Medical2016-10-20
LIPOSORBER(R) LA-15 SYSTEM (P910018/S021)Kaneka Pharma America Corp.2016-10-14
ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR (P070009/S017)Obtech Medical GmbH2016-10-11
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S092)Medtronic Neuromodulation2016-10-04
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P970004/S197)Medtronic Neuromodulation2016-10-04
LIPOSORBER® LA-15 SYSTEM (P910018/S020)Kaneka Pharma America Corp.2016-09-23
MAESTRO RECHARGEABLE SYSTEM (P130019/S010)Reshape Lifesciences, Inc.2016-09-20
INTERSTIM THERAPY SYSTEM (P080025/S122)Medtronic Neuromodulation2016-09-14
INTERSTIM THERAPY SYSTEM (P970004/S227)Medtronic Neuromodulation2016-09-14
InterStim Therapy System (P970004/S226)Medtronic Neuromodulation2016-09-13
InterSlim Therapy System (P080025/S121)Medtronic Neuromodulation2016-09-13
AspireAssist (P150024/S003)Aspire Bariatrics, Inc.2016-09-13
InterStim Therapy System (P970004/S224)Medtronic Neuromodulation2016-09-09
InterStim Therapy System (P080025/S119)Medtronic Neuromodulation2016-09-09
HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S021)B. Braun Avitum AG2016-09-09
OBALON BALLOON SYSTEM (P160001)Medtimo, Inc.2016-09-08
AspireAssist (P150024/S001)Aspire Bariatrics, Inc.2016-09-01
INTERSTIM Therapy System for Bowel Control (P080025/S118)Medtronic Neuromodulation2016-08-31
INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S223)Medtronic Neuromodulation2016-08-31
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S065)Boston Scientific Corp2016-08-30
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S218)Medtronic Neuromodulation2016-08-24
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S113)Medtronic Neuromodulation2016-08-24
INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S222)Medtronic Neuromodulation2016-08-22
INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S117)Medtronic Neuromodulation2016-08-22
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL (P080025/S116)Medtronic Neuromodulation2016-08-05
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S221)Medtronic Neuromodulation2016-08-05
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S117)Boston Scientific Corp2016-08-03
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE (P000053/S066)Boston Scientific Corp2016-08-03
INTERSTIM THERAPY SYSTEM (P970004/S219)Medtronic Neuromodulation2016-07-27
INTERSTIM THERAPY SYSTEM (P080025/S114)Medtronic Neuromodulation2016-07-27
INTERSTIM THERAPY SYSTEM (P080025/S115)Medtronic Neuromodulation2016-07-20
INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S220)Medtronic Neuromodulation2016-07-20
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S217)Medtronic Neuromodulation2016-07-13
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S112)Medtronic Neuromodulation2016-07-13
INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S216)Medtronic Neuromodulation2016-07-07
INTERSTIM THERAPY SYSTEM (P970004/S215)Medtronic Neuromodulation2016-07-07
INTERSTIM THERAPY SYSTEM (P080025/S110)Medtronic Neuromodulation2016-07-07
INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S111)Medtronic Neuromodulation2016-07-07
INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S109)Medtronic Neuromodulation2016-07-01
INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S214)Medtronic Neuromodulation2016-07-01
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S116)Boston Scientific Corp2016-06-30
AMS 800 ARTIFICIAL URINARY SPHINCTER WITH INHIBIZONE TREATMENT (P000053/S064)Boston Scientific Corp2016-06-30
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