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Gastroenterology, Urology

11,291 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Reprocessed Covidien Trocar (K172093)Renovo, Inc.2017-10-05
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit (K172558)Stryker Corporation2017-10-05
CRE RX Biliary Balloon Dilatation Catheter (K172520)Boston Scientific Corporation2017-10-04
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (K172289)Q Urological Corporation2017-10-04
Ablatherm Fusion (K172285)Edap Technomed, Inc.2017-10-03
Endoscopic Ultrasound Aspiration Needle (K172309)Micro-Tech (Nanjing) Co., Ltd.2017-09-29
Resection Electrodes with HF cable (K171965)Olympus Winter & Ibe GmbH2017-09-28
Vesco Medical Nasoenteric Feeding Tubes (K170162)Vesco Medical, LLC2017-09-26
LapBag (K171726)Sejong Medical Co., Ltd.2017-09-25
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (K170879)Intuitive Surgical, Inc.2017-09-21
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (K170641)Intuitive Surgical, Inc.2017-09-21
Magic3 Go Intermittent Urinary Catheter (K172247)C.R. Bard, Inc.2017-09-20
PENTAX Medical ED34-i10T, Video Duodenoscope (K163614)Pentax Medical2017-09-20
Tri-Ex Extraction Balloon With Multiple Sizing (K170292)Wilson-Cook Medical, Inc.2017-09-20
da Vinci Xi Surgical System (K171632)Intuitive Surgical, Inc.2017-09-19
Accordion Piccolo Stone Management Device (K172299)Ths International, Inc. D/B/A Accordion Medical2017-09-19
Fresenius Liberty Select Cycler (K171652)Fresenius Medical Care Renal Therapies Group, LLC2017-09-15
Veress Needle (K172120)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017-09-14
Bard Mission Disposable Core Biopsy Instrument (K171953)Bard Peripheral Vascular, Inc.2017-09-14
Entuit Start Initial Placement Gastrostomy Set (K170323)Cook Incorporated2017-09-14
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories (K170875)Intuitive Surgical, Inc.2017-09-12
Navina Classic System (K170487)Dentsply Sirona2017-09-11
da Vinci Xi EndoWrist Instruments and Accessories (K170645)Intuitive Surgical, Inc.2017-09-11
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) (K170644)Intuitive Surgical, Inc.2017-09-11
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (K171531)Care Fusion2017-09-11
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (K170210)Given Imaging , Ltd.2017-09-01
Medical Video Endoscope System (K172098)Zhuhai Pusen Medical Technology Co., Ltd.2017-08-31
Laport (K171741)Sejong Medical Co., Ltd.2017-08-29
Salle Intraoperative Pyeloplasty Stent Set (K170010)Cook Incorporated2017-08-28
NxStage System One (K171331)Nxstage Medical, Inc.2017-08-24
Endoscopic Injection Needle (K172227)Carbon Medical Technologies, Inc.2017-08-23
ShockPulse-SE Lithotripsy System (K171024)Cybersonics, Inc.2017-08-21
UroLift System (UL500) (K172359)Neotract, Inc.2017-08-18
Zimmon Needle Knife Papillotome (K171993)Wilson-Cook Medical Inc./Cook Endoscopy2017-08-17
Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531)Coloplast Corp.2017-08-17
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (K171983)Creo Medical, Ltd.2017-08-17
U Deliver Bolink ENFit Enteral Feeding Sets (K170555)U Deliver Medical, LLC2017-08-17
DeRoyal Laprador Specimen Retrieval System (K171475)Deroyal Industries, Inc.2017-08-17
Diacap Pro Dialyzer (K170574)B. Braun Avitum AG2017-08-11
Epic Biliary Endoscopic Stent System (K171809)Boston Scientific Corporation2017-08-09
Delta III Lithotripter (K172084)Dornier Medtech America, Inc.2017-08-08
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle (K171596)Wilson-Cook Medical, Inc.2017-08-04
Cellvizio 100 Series Systems with Confocal Miniprobes (K171345)Mauna Kea Technologies2017-08-04
Medrobotics Flex Robotic System (K172036)Medrobotics Corporation2017-08-03
14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619)Cook Ireland, Ltd.2017-08-01
Nasal Pancreatic Drainage Set (K171623)Cook Ireland, Ltd.2017-07-31
Bronchi and Gastrointestinal Cytology Brush (K171607)Wilson-Cook Medical Inc./Cook Endoscopy2017-07-31
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System (K171699)Intuitive Surgical, Inc.2017-07-28
Williams Cystoscopic Injection Needle (K171602)Cook Incorporated2017-07-28
FTRD System Set (K170867)Ovesco Endoscopy AG2017-07-25
Fujifilm Duodenoscope Model ED-530XT (K152257)Fujifilm Medical Systems U.S.A, Inc.2017-07-21
GelPOINT Path Transanal Access Platform (K171701)Applied Medical Resources Corp.2017-07-20
DORA Disposable A.V. Fistula Needle Sets (K163025)Bain Medical Equipment (Guangzhou) Co., Ltd.2017-07-20
Disposable Standard Clamp (K170379)Standard Bariatrics2017-07-19
Relizorb (K163057)Alcresta Therapeutics, Inc.2017-07-12
Interject Injection Therapy Needle Catheter (K171454)Boston Scientific Corporation2017-07-07
Everyway Incontinence Stimulation System (K161349)Everyway Medical Instrument Co., Ltd.2017-07-07
Karl Storz UROMAT E.A.S.I. (K162992)Karl Storz Endoscopy America, Inc.2017-07-07
Delta III Lithotripter (K170122)Dornier Medtech America2017-06-28
Tria Firm Ureteral Stent (K163399)Boston Scientific Corporation2017-06-22
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories (K171307)Endogastric Solutions, Inc.2017-06-22
Embosphere Microspheres (DEN160040)Biosphere Medical, S.A.2017-06-21
Möller Medical Biopsy Needles and Systems (K162588)Moller Medical GmbH2017-06-19
DORA Tubing Sets for Hemodialysis (K161582)Bain Medical Equipment (Guangzhou) Co., Ltd.2017-06-16
Quantum TTC Biliary Balloon Dilator (K171223)Wilson-Cook Medical, Inc.2017-06-16
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749)Fujifilm Medical Systems U.S.A, Inc.2017-06-15
Howell Biliary Introducer Needle (K160890)Wilson-Cook Medical, Inc.2017-06-14
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree (K171426)Intuitive Surgical, Inc.2017-06-13
da Vinci Xi Surgical System (K170713)Intuitive Surgical, Inc.2017-06-13
Kwart Retro-Inject Ureteral Stent (K162109)Cook Incorporated2017-06-07
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection (K171347)Xeridiem Medical Devices2017-06-06
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) (K163609)Pall International Sarl2017-06-01
Xenocor Xenoscope Laparoscopic System (K171344)Xenocor, Inc.2017-06-01
EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388)Intuitive Surgical, Inc.2017-05-31
27HJ713S (K170899)Lg Electronics2017-05-30
da Vinci X Surgical System (K171294)Intuitive Surgical, Inc.2017-05-26
RAPID Web (K170839)Given Imaging , Ltd.2017-05-26
KARL STORZ ICG Imaging System (K171238)KARL STORZ Endoscopy-America, Inc.2017-05-25
VitreOx Anti-fog Solution (K163257)Sio2 Nanotech, LLC2017-05-24
Plasma Edge System (K163090)Chirurgie Innovation2017-05-23
Barone Jejunostomy Catheter Set (K160567)Cook Incorporated2017-05-18
SmartByte Device (K171165)Scientific Intake2017-05-18
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509)Cook Incorporated2017-05-18
bibag (K162716)Fresenius Medical Care Renal Therapies Group, LLC2017-05-18
Kangaroo Feeding Tube with IRIS Technology (K163002)Covidien (Dba Medtronic)2017-05-16
Fujifilm Diathermic Slitter (FlushKnife) (K171096)Fujifilm Medical Systems U.S.A, Inc.2017-05-09
NxStage System One Plus (K170469)Nxstage Medical, Inc.2017-05-09
GORE VIABIL Short Wire Biliary Endoprosthesis (K170740)W. L. Gore & Associates, Inc.2017-05-08
Rusch Silicone Foley Catheter (K161770)Teleflexmedical, Inc.2017-05-05
Medical Video Endoscope System (K171076)Zhuhai Pusen Medical Technology Co., Ltd.2017-05-05
Flex Robotic System and Flex Colorectal Drive (K162330)Medrobotics Corporation2017-05-04
Cedic Enteral ENFit Transition Connectors (K162254)Cedic S.R.L.2017-05-04
Asahi ViE-U Series Dialyzer (K162248)Asahi Kasei Medical Co., Ltd.2017-05-03
PrisMax Control Unit (K163530)Baxter Healthcare Corp2017-05-03
Scope-Assist Flushing Sink (K162120)Custom Ultrasonics, Inc.2017-04-28
Accessory Irrigation Adapter (K162142)Wilson-Cook Medical, Inc.2017-04-27
Processor VP-7000, Light Source BL-7000 (K163675)Fujifilm Medical System U.S.A., Inc.2017-04-25
C-Flex Ureteral Stent Set (K162104)Cook Incorporated2017-04-24
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (K170865)Intuitive Surgical, Inc.2017-04-21
EndoFLIP® System with FLIP Topography module (K170833)Crospon, Ltd.2017-04-17
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