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Gastroenterology, Urology

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

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RecordFirmDate
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar (K141594)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-08-10
Corvocet Coaxial Introducer (K151373)Merit Medical Systems, Inc.2015-08-07
Resolution Clip (K151802)Boston Scientific Corporation2015-08-06
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
Polypectomy Snare (K150316)Micro-Tech (Nanjing) Co., Ltd.2015-07-30
Gemini XXP-HP (K151298)Dornier Medtech America2015-07-30
Infinity ERCP Sampling Device (K151889)United States Endoscopy Group, Inc.2015-07-30
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor (K150377)Sony Electronics, Inc.2015-07-29
Bard LubriGuard Foley Catheter (K150699)C.R. Bard, Inc.2015-07-28
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (K143102)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2015-07-24
Medline ENFit Connectors (K151628)Medline Industries, Inc.2015-07-24
Flexi-Seal Signal Fecal Management System (K150350)Convatec, Ltd.2015-07-21
Evacore Fully Disposable Vacuum Assist Biopsy Device (K150088)Pin-Point Care Corp.2015-07-20
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (K150084)Covidien2015-07-13
mcompass Biofeedback Anorectal Manometry System (K143031)Medspira, LLC2015-07-07
FUJIFILM Endoscope Models EC-600HL and EC-600LS (K143732)Fujifilm Medical Systems U.S.A, Inc.2015-07-06
Lariat snare (K151197)United States Endoscopy Group, Inc.2015-07-06
VersaOne Bladed Trocar, VersaOne Bladeless Trocar (K151548)Covidien2015-07-02
SpeediCath Compact Eve (K150935)Coloplast A/S2015-07-02
Artemis Hand Held Imaging System (K143474)Quest Medical Imaging2015-06-30
MIDSLEEVE (K142548)Medical Innovation Development2015-06-23
Tissue Removal Pouch (K150781)Boehringer Laboratories, LLC2015-06-19
Spacemaker Pro Access and Dissector System (K151356)Covidien, LLC2015-06-18
VS3-IR-MMS System (K150018)Visionsense, Ltd.2015-06-17
Urinary Incontinence System (K142369)Guangzhou Finecure Medical Equipment Co.,Ltd2015-06-17
Wi-3 HAL-RAR System (K150718)Agency For Medical Innovations GmbH2015-06-12
LaparoVue (K150569)Buffalo Filter, LLC2015-06-10
AMT Enteral Transition Adapters (K150034)Applied Medical Technology, Inc.2015-06-09
Morrison Steerable Needle (K150625)Apriomed AB2015-06-09
Ensizor Endoscopic Scissors (K150939)Slater Endoscopy, LLC2015-06-08
smARTrack Feeding Tube System (K142327)Art Healthcare , Ltd.2015-06-08
MUSE System (K151001)Medigus , Ltd.2015-06-05
NxStage System One (K150472)Nxstage Medical, Inc.2015-06-04
Injection Needle (K150434)Micro-Tech (Nanjing) Co., Ltd.2015-06-02
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER (K141531)C.R. Bard, Inc.2015-06-01
Reactor(TM) Trocar and Sleeve (K150549)Sharp Medical Prducts, LLC2015-06-01
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (K150927)Coloplast A/S2015-05-27
AMT Bridle - Nasal Tube Retention System (K142971)Applied Medical Technology, Inc.2015-05-26
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER (K141902)Lagis Enterprises Co, Ltd.2015-05-26
Marrow Cellution Bone Marrow Aspiration Needle (K150563)Ranfac, Corp.2015-05-22
IS4000 da Vinci EndoWrist Instruments (K150284)Intuitive Surgical, Inc.2015-05-15
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (K142629)Fujifilm Medical System U.S.A., Inc.2015-05-14
JMS Harmony A.V. Fistula Needle Set (K151017)JMS North America Corporation2015-05-13
Magic3 Go Intermittent Urinary Catheter (K150345)C.R. Bard, Inc.2015-05-11
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE (K141910)Biologic Therapies, Inc.2015-05-04
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (K150891)Covidien, LLC( Formerly Beacon Endoscopic Corp.)2015-05-01
Tablo Console with Wireless Capability (K150880)Outset Medical2015-05-01
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps (K150837)Intuitive Surgical, Inc.2015-04-29
ULTRA Telescopes (K150633)Olympus Winter & Ibe GmbH2015-04-29
Medline Enteral Feeding Sets (K150286)Medline Industries, Inc.2015-04-27
YARLAP (K141643)International Trade Group, Inc.2015-04-24
TensCare KegelFit (K142506)Tenscare, Ltd.2015-04-20
Sidecar External Working Channel (K150083)C2 Therapeutics2015-04-14
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator (K150705)Minimally Invasive Devices, Inc.2015-04-13
NeoMed NeoConnect Enteral Syringes with ENFit Connector (K143344)Neomed, Inc.2015-04-09
ApexM (K150183)Incontrol Medical, LLC2015-04-09
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (K150010)Cedic S.R.L.2015-04-02
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors (K143018)Covidien2015-04-02
IS4000 8mm Harmonic ACE Curved Shears (K143132)Intuitive Surgical, Inc.2015-04-02
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (K150253)Taiwan Surgical Corporation2015-04-01
CRIT-LINE IV SYSTEM (K141997)Fresenius Medical Care2015-04-01
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP (K141991)Olympus Medical Systems Copr.2015-03-31
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) (K143567)Marvao Medical Devices, Ltd.2015-03-31
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter (K143609)Olympus Surgical Technologies America2015-03-27
GLOVE PORT (K141715)Nelis2015-03-25
LM-9300 ELMA Lithotripter (K142561)Lite-Med, Inc.2015-03-20
PROLONG (DEN130047)Ergon Medical , Ltd.2015-03-20
NxStage Therapeutic Plasma Exchange (TPE) Cartridge (K143313)Nxstage Medical, Inc.2015-03-20
Imbibe Aspirating XIA Taps (K143546)Stryker Corporation2015-03-19
MiroCam Capsule Endoscope System (K143663)Intromedic Co., Ltd.2015-03-17
InTone (K150180)Incontrol Medical, LLC2015-03-16
ARTEMIS LIGHT ENGINE (K141164)Quest Medical Imaging2015-03-16
NovaGold High Performance Guidewire (K150225)Neometrics, Inc.2015-03-16
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE (K142068)Medovations, Inc.2015-03-10
Entriport (K142464)Conmed Corporation2015-03-05
EsophyX® Z Fastener Delivery Device (K143645)Endogastric Solutions, Inc.2015-03-04
Single Use Biliary Balloon Dilator (K143303)Olympus Medical Systems Corp.2015-02-27
GastriSail Gastric Positioning System (K143088)Covidien2015-02-25
Synergetics PHOTON EX (K143123)Synergetics2015-02-24
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR (K142128)Covidien2015-02-23
ECLIPSE SYSTEM (DEN140020)Pelvalon2015-02-12
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT (K142680)Olympus Medical Systems Corp.2015-02-08
Laparoscopic Handles with peek Insulation (K150127)Stryker Endoscopy2015-02-04
ThinkMed Intermittent Catheter with/without Hydrophilic Coating (K142767)Thinkmed Medical Technology Co., Ltd.2015-02-03
Mini ONE Enteral Extension Set (K142989)Applied Medical Technology, Inc.2015-01-29
ELECTRODE FOR URINARY INCONTINENCE (K140265)Guangzhou Finecure Medical Equipment Co.,Ltd2015-01-23
Spectra Soft Tissue Biopsy Needles (K142791)Spectra Medical Devices2015-01-21
Percuvance(R) Percutaneous Surgical System (K143299)Teleflexmedical, Inc.2015-01-21
ENDOCHOICE WATER BOTTLE CAP SYSTEM (K142155)Endochoice, Inc.2015-01-20
MUSE System (K143634)Medigus , Ltd.2015-01-20
Speedicath Compact Male (K143182)Coloplast A/S2015-01-20
SpyGlass DS Direct Visualization System (K142922)Boston Scientific Corporation2015-01-16
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (K131950)Summit International Medical Technologies, Inc.2015-01-16
DISPOSABLE INJECTION NEEDLE (K142144)Wilson Instruments (Shanghai) Company Limited2015-01-15
AbbVie NJ (K142792)AbbVie , Inc.2015-01-14
AbbVie J (K142816)AbbVie , Inc.2015-01-14
AbbVie PEG (K142793)AbbVie , Inc.2015-01-14
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K140984)Tango3, LLC2015-01-12
Medline Silicone Foley Catheter (K142635)Medline Industries, Inc.2015-01-09
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