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GCJ

1,426 FDA 510(k) clearances · Product code

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RecordFirmDate
PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER (K130826)Stryker Endoscopy2013-08-01
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K131688)Neosurgical, Ltd.2013-07-18
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE (K131115)Nds Surgical Imaging2013-06-07
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K123280)Neosurgical, Ltd.2013-04-18
VS3 (K123467)Visionsense, Ltd.2013-04-17
SHORT PORT BLUNT TIP TROCAR (K130121)Boston Scientific Corporation2013-04-11
VERSAPORT V2 BLADELESS OPTICAL TROCAR (K130435)Covidien, Formerly US Surgical A Divison of Tyco H2013-03-14
Medafor Direct Gas-Assisted Application System (K123325)Medafor, Inc.2013-01-24
PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 (K123110)Surgical Innovations Plc2013-01-17
MALLEABLE TIP ENDOSCOPIC APPLICATOR (K123847)Micromedics, Inc.2013-01-08
SOVEREIGN MINI (K123102)Aesculap, Inc.2013-01-03
360 GAS ASSISTED ENDOSCOPIC APPLICATOR (K122526)Micromedics, Inc.2012-11-16
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR (K122299)Transenterix, Inc.2012-10-25
WECK REUSABLE OBTURATOR (K121796)Teleflexmedical, Inc.2012-10-11
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH (K122511)Ethicon Endo-Surgery, LLC2012-10-01
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS (K120012)Integra LifeSciences Corporation2012-09-11
STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM (K121893)Stryker Endoscopy2012-09-05
WIRELESS IMAGE TRANSMITTER UNIT (K120278)Olympus Medical Systems Corp.2012-08-10
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR (K120468)Cook Incorporated2012-07-06
SYSTEMS INTEGRATION (K121701)Olympus Medical Systems Corp.2012-06-29
SONY PVM-2551MD OLED MONITOR (K120611)Sony Electronics, Inc.2012-06-28
WIS1000 (K112621)Foreseeson Custom Displays, Inc.2012-05-30
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT (K121380)Teleflexmedical, Inc.2012-05-25
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER (K120403)Transenterix, Inc.2012-04-16
WOUND PROTECTOR (K120061)Covidien, Formerly US Surgical A Divison of Tyco H2012-03-27
ENDOSCOPIC APPLICATOR (K120608)Micromedics, Inc.2012-03-15
SURGICAL RETRACTORS (K112659)Surgical Innovations Plc2012-03-09
SONY LMD-2451MT LCD MONITOR (K113203)Sony Electronics, Inc.2012-02-24
UNIMAX TROCAR SYSTEM (K112358)Unimax Medical Systems, Inc.2011-10-17
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT (K112456)Teleflexmedical, Inc.2011-10-04
THE ESPINER SAC OR E SAC (K111845)Espiner Medical Limited2011-09-26
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR (K112349)Covidien, Formerly US Surgical A Divison of Tyco H2011-09-01
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES (K101733)Sac, LLC Dba Pinnacle Medical Surgical2011-06-06
UNIMAX SUCTION IRRIGATION SET (K103509)Unimax Medical Systems, Inc.2011-05-19
WEXLER ENDOSCOPE ACCESSORIES (K110121)Microsurgical Laboratories,Inc.Dba Wexler Surgical2011-05-10
UNIMAX SPECIMEN RETRIEVAL SYSTEM (K103510)Unimax Medical Systems, Inc.2011-05-06
DIAMOND-FLEX(R) GRASPERS (K110257)Carefusion 2200, Inc.2011-05-06
SPIDER STANDARD AND ADVANCED (K102839)Transenterix, Inc.2011-03-15
SURGISURE TISSUE REMOVAL SYSTEM (K103741)Interlace Medical, Inc.2011-03-02
SILS PORT (K103253)Coviden (Formerly Registered AS US Surgical, A Div2011-02-24
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, (K100533)Vibrynt, Inc.2011-02-08
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 (K101077)Intuitive Surgical, Inc.2011-02-04
LTF-Y0009; MAJ-YOO41; XOEV-3D1 (K102379)Olympus Medical Systems Corporation2011-01-05
SPIDER FLEX MONOPOLAR HOOK (K102646)Transenterix, Inc.2010-11-03
PMC LAPAROSCOPIC INSTRUMENTS (K101193)Pmc Medical GmbH2010-10-18
SOCORRO SMI TUNNEL RELEASE DEVICE (K102219)Socorro Medical, Inc.2010-09-24
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM (K100442)Surgical Innovations Group Plc2010-09-07
3DHJD CAMERA SYSTEM MODEL (K101810)Vision Systems Group, A Division of Viking Systems2010-08-30
INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT (K093783)Innovia, LLC2010-08-23
MODULAR ENDOSCOPE (K093785)Sialo Technology, Ltd.2010-08-18
HYBRID TROCAR SYSTEM (K101937)Aesculap, Inc.2010-08-11
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE (K100109)Surgical Innovations Plc2010-07-15
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR (K101671)Teleflexmedical, Inc.2010-06-25
OCTO (K100045)Dalim Surgnet Corporation2010-06-25
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789)Terumo Cardiovascular Systems Corp.2010-05-12
SURGIQUEST ANCHORPORT SIL KIT (K100180)Surgiquest, Inc.2010-05-05
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP (K100548)Covidien Lp, Formerly Registered AS Tyco Healthcar2010-04-26
SPECIMEN RETRIEVAL SYSTEM (K100959)Applied Medical Resources2010-04-22
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X (K100195)Nds Surgical Imaging2010-04-21
NAVIX ACCESS DEVICE (K093279)Xlumena2010-04-07
LAPORT (K092584)Mgb Endoskopische Gerate GmbH (Berlin)2010-03-22
ENDOCLEAR SYSTEM (K100346)Virtual Ports, Ltd.2010-03-10
OPTISCAN MODEL OPTISCAN CEIS (K093624)Optiscan Pty. , Ltd.2010-03-05
MGB DISPOSABLE RETRIEVAL BAG LAPBAG (K093194)Mgb Endoskopische Gerate GmbH (Berlin)2010-03-03
MINI LAP RETRACTORS (K093449)Mini Lap Technologies, Inc.2010-02-12
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 (K092821)Agency For Medical Innovations, Inc.2010-02-01
LAPAROSCOPIC RETRACTORS (K092684)Cardinal Health, Inc.2010-01-22
SILS PORT MODEL SILSPT15 (K093372)Covidien Lp, Formerly Registered AS Tyco Healthcar2009-12-03
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM (K092504)Surgiquest, Inc.2009-11-05
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (K091697)Transenterix, Inc.2009-09-28
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB (K091930)Anchor Products Co.2009-09-23
ESTECH HAWKEYE INTRODUCER SYSTEMS (K091350)Endoscopic Technologies, Inc. D/B/A Estech2009-09-15
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS (K091211)Ethicon Endo-Sugery, LLC2009-09-04
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS (K091869)Covidien Lp, Formerly Registered AS United States2009-09-01
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 (K091648)Conmed Integrated Systems (Cmis)2009-08-05
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 (K090902)Transenterix, Inc.2009-07-22
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (K091515)Novadaq Technologies, Inc.2009-07-09
MITAKA UNIARM (K090792)Mitaka Kohki Co., Ltd.2009-07-06
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES (K090979)Encision, Inc.2009-05-28
FREEHAND (K090340)Prosurgics Limited2009-05-22
INNOPORT LAPAROSCOPIC ACCESS DEVICE (K090677)Innovia, LLC2009-05-07
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS (K090631)PAJUNK GmbH Medizintechnologie2009-04-16
SOPRO 184 CAMERA (K082796)Sopro2009-04-01
STONE GRASPING BASKET, MODEL PD-T1 2115 (K082735)Sialo Technology, Ltd.2009-03-13
TC ENDO PORT (K083218)Transcardiac Therapeutics, Inc.2009-03-06
GELPORT SINGLE INCISION ACCESS SYSTEM (K090275)Applied Medical Resources Corp.2009-02-18
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 (K083194)Terumo Cardiovascular Systems Corp.2009-01-16
A-LAP SET (A-LAP, EZAXESS, TROCAR) (K082291)Ezsurgical2009-01-02
FIXATION TROCARS (K083638)Applied Medical Resources Corp.2008-12-23
VIKY (K082233)Endocontrol2008-12-18
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K083211)Surgiquest, Inc.2008-12-15
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS (K082322)Covidien2008-11-14
SILS PORT, MODELS SILSPT5, SILSPT12 (K082619)Covidien Lp, Formerly Registered AS United States2008-11-07
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) (K081995)Stryker Endoscopy2008-10-02
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 (K082156)Teleflex Medical2008-09-10
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR (K080161)Patton Surgical Corp.2008-05-29
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR (K081169)Covidien Lp, Formerly Registered AS United States2008-05-23
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS (K080257)Medtronic Xomed, Inc.2008-05-22
3 CCD ENDOCAM 5550 (K080977)Richard Wolf Medical Instruments Corp.2008-05-14
SIALO BALLOON DILATATION CATHETER (K072749)Sialo Technology, Ltd.2008-05-14
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