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GCJ

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

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RecordFirmDate
ALVUE Balloon Dilation System (K171939)Globus Medical, Inc.2018-03-07
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments (K170683)Aesculap, Inc.2018-02-20
Ergonomic Handle (K173272)Symmetry Surgical, Inc.2018-02-09
Specimen Retrieval Bag (K172789)Beijing Hangtian Kadi Technology R&D Institute2018-02-01
Equipment Pouch (K172578)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017-12-07
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (K172618)Olympus Medical Systems Corp.2017-12-05
Suction Irrigation Set (K172794)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017-11-29
Trocar (K172038)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017-10-27
ANCHOR Tissue Retrieval System (K172940)Conmed Corporation2017-10-18
Endoscopic Applicator, 41 cm (K172672)Micromedics, Inc. (D/B/A Nordson Medical)2017-10-06
LapBag (K171726)Sejong Medical Co., Ltd.2017-09-25
Laport (K171741)Sejong Medical Co., Ltd.2017-08-29
DeRoyal Laprador Specimen Retrieval System (K171475)Deroyal Industries, Inc.2017-08-17
Disposable Standard Clamp (K170379)Standard Bariatrics2017-07-19
Xenocor Xenoscope Laparoscopic System (K171344)Xenocor, Inc.2017-06-01
27HJ713S (K170899)Lg Electronics2017-05-30
ZeroWire Mobile (K170598)Nds Surgical Imaging, LLC2017-04-07
FUJIFILM Surgical System (K162836)Fujifilm New Development U.S.A., Inc.2017-03-13
NOVATECH TALCAIR (K170030)Novatech SA2017-03-13
InterLock Trocar (K170084)Fujifilm New Development U.S.A., Inc.2017-03-10
VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar (K163654)Covidien, LLC2017-03-08
Laparoscope Lens Shield Device (LENS) (K170103)Medeon Biodesign, Inc.2017-02-16
EndoClot (K162197)Endoclot Plus Co., Ltd.2017-01-18
U-IGNITE Bladeless Trocar (K162387)Tianjin Uwell Medical Device Manufacturing Co., Ltd.2017-01-11
ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm (K163102)Covidien2016-11-30
Well Lead Extraction Bag (K160801)Well Lead Medical Co., Ltd.2016-11-29
Disposal Lens Cleaning Sheath (K153773)Olympus Medical Systems Corp.2016-11-22
Standard Clamp (K161720)Standard Bariatrics2016-10-24
LiVac Retractor System (K162445)Livac Pty, Ltd.2016-10-20
VersaOne Bladeless Trocar (K162584)Covidien2016-10-18
EZEE RETRIEVAL (K162059)Genicon, Inc.2016-09-29
Xenocor Xenoscope Laparoscopic System (K161838)Xenocor, Inc.2016-09-26
PINPOINT Endoscopic Fluorescence Imaging System (K161792)Novadaq Technologies, Inc.2016-09-20
Pelican Sling Retractor (K153542)Beacon Surgical, Inc.2016-09-07
Laparoscopic Spray Applicator with Spinning Luers (K162077)Micromedics, Inc. (D/B/A Nordson Medical)2016-08-11
Single Use Surgical Suction Irrigator (K161421)Jiangsu Haize Medical Scientific Development Co., Ltd.2016-06-24
Sony IP Converter NU-IP40S (K161122)Sony Electronics, Inc.2016-06-08
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (K153606)Smith & Nephew2016-06-02
Radiance Ultra Series ZeroWire Embedded (K161228)Nds Surgical Imaging, LLC2016-05-26
AdTec (K160393)Aesculap, Inc.2016-05-26
PINPOINT Endoscopic Fluorescence Imaging System (K150956)Novadaq Technologies, Inc.2016-05-23
Stryker SDC3 HD Information Management System with Wireless Device Control Capability (K160332)Stryker Endoscopy2016-05-18
True HD 3MOS Camera System (K161017)Conmed Corporation2016-05-09
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (K152619)Prosurg, Inc.2016-04-29
Laparoscope Lens Shield Device (K160172)Medeon Biodesign, Inc.2016-04-21
NOVATECH TALCAIR (K151832)Novatech SA2016-03-31
VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm (K160230)Covidien2016-03-01
Arthrex Synergy UHD4 System (K153218)Arthrex, Inc.2016-02-12
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments (K151036)Carefusion 2200, Inc.2016-02-01
VersaOne Bladed Trocar 5mm (K152149)Covidien2016-01-22
General & Plastic Surgery Instruments (K152400)Sontec Instruments, Inc.2016-01-22
8X-10-XXXX Camera System (K152513)Santa Barbara Imaging Systems2015-12-15
da Vinci Xi Hasson Cone (K153126)Intuitive Surgical, Inc.2015-12-09
AUTOLAP SYSTEM (K152848)M.S.T Medical Surgery Technologies, Ltd.2015-11-17
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 (K151609)Nds Surgical Imaging, LLC2015-11-06
Retrieval bag system (K151489)Beacon Surgical, Inc.2015-10-26
Bladeless Optical Obturators (K152663)Intuitive Surgical, Inc.2015-10-16
Auto Suture Locking Trocar (K152565)Covidien2015-10-09
KSEA CMOS Camera System (C-cam) (K143640)KARL STORZ Endoscopy-America, Inc.2015-09-17
Tissue Removal System (K151990)Boehringer Laboratories, LLC2015-09-11
ab medica irrigation/suction gravity system (K151822)Ab Medica Sas2015-09-04
Laparoscope Lens Shield Device (K151117)Medeon Biodesign, Inc.2015-08-20
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar (K141594)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-08-10
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
VersaOne Bladed Trocar, VersaOne Bladeless Trocar (K151548)Covidien2015-07-02
Tissue Removal Pouch (K150781)Boehringer Laboratories, LLC2015-06-19
Spacemaker Pro Access and Dissector System (K151356)Covidien, LLC2015-06-18
LaparoVue (K150569)Buffalo Filter, LLC2015-06-10
Reactor(TM) Trocar and Sleeve (K150549)Sharp Medical Prducts, LLC2015-06-01
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER (K141902)Lagis Enterprises Co, Ltd.2015-05-26
ULTRA Telescopes (K150633)Olympus Winter & Ibe GmbH2015-04-29
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
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (K150253)Taiwan Surgical Corporation2015-04-01
GLOVE PORT (K141715)Nelis2015-03-25
Entriport (K142464)Conmed Corporation2015-03-05
Laparoscopic Handles with peek Insulation (K150127)Stryker Endoscopy2015-02-04
Percuvance(R) Percutaneous Surgical System (K143299)Teleflexmedical, Inc.2015-01-21
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 (K142427)Applied Medical Resources2014-12-23
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (K140593)Cook, Inc.2014-12-15
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm (K142547)Covidien2014-12-09
Schoelly Laparoscope (K143221)Schoelly Fiberoptic GmbH2014-12-05
Surgisleeve Wound Protector (K143091)Covidien, LLC2014-11-26
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH (K141593)Unimicro Medical Systems (Shenzhen) Co., Ltd.2014-11-13
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US (K142903)Neosurgical, Ltd.2014-11-12
Stryker Precision HD Camera System (K142603)Stryker Endoscopy2014-10-23
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR (K141272)Minimmally Invasive Devices2014-09-04
UNIMICRO SUCTION IRRIATION TUBING SET (K141592)Unimicro Medical Systems (Shenzhen) Co., Ltd.2014-08-04
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS (K140101)Ab Medica Sas2014-07-10
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG (K132375)Genicon2014-06-12
FLEX ENDOSCOPIC INSTRUMENTS (K140662)Design Standards Corp.2014-06-11
VTI SUCTION IRRIGATION SYSTEM (K141323)Regulatory Technology Services, LLC2014-06-04
VERSACUT + TISSUE MORCELLATOR (K133272)Lumenis, Ltd.2014-05-13
SINGLE-SITE PORT (K133203)Intuitive Surgical, Inc.2014-05-09
REVEEL ENDOSCOPIC RETRACTOR (K133345)Retraction Limited2014-04-11
8MM TROCAR KIT (K133845)Intuitive Surgical2014-02-19
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR (K133375)Banyan Medical, LLC2014-01-17
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY (K132785)Stryker Endoscopy2013-12-16
RETRIEVAL BAG (K123728)Flexbar Machine Corp.2013-12-11
AUTOLAP SYSTEM (K131375)Mst - Medical Surgery Technologies , Ltd.2013-09-19
SURGIQUEST AIRSEAL IFS (K132169)Surgiquest, Inc.2013-08-22
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