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GCJ

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

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RecordFirmDate
Scivita 4KINSIGHT ICG Imaging System (K221252)Scivita Medical Technology Co., Ltd.2023-01-13
HandX Instrument - Monopolar Spatula (K222011)Human Xtensions , Ltd.2023-01-12
HOPKINS Telescopes (K221004)Karl Storz Endoscopy America, Inc.2022-12-20
HurriChem Device Kit (K222575)Thermasolutions, LLC2022-12-06
Canady Flex RoboWrist (K212736)Us Medical Innovations, LLC2022-11-22
H1 (K222504)Karl Storz Endoscopy America, Inc.2022-11-10
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) (K221740)Smith and Nephew, Inc.2022-10-20
RADIANCE ULTRA 32 4K ZEROWIRE DUO (K222890)Nds Surgical Imaging, LLC2022-10-19
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K222079)Stryker Endoscopy2022-10-11
Plasma Shield (K221533)Plasmatica, Ltd.2022-09-12
LapBox Tissue Containment Removal System (K221365)Ark Surgical, Ltd.2022-08-25
1688 4K Camera System with Advanced Imaging Modality (K222130)Stryker2022-08-19
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula (K213818)Covidien2022-06-27
CORE-Trocar (K211148)Incore Co., Ltd.2022-06-21
SPY Laparoscope (K221217)Stryker2022-06-17
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (K214046)Stryker2022-05-25
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) (K220895)Stryker2022-04-22
Saberscope5 Laparoscope (K220872)Xenocor, Inc.2022-04-20
Alexis Contained Extraction System (K211043)Applied Medical Resources Corporation2022-03-31
ArthroFree Wireless Surgical Camera System (K213860)Lazurite Holdings, LLC2022-03-23
4K UHD LCD Monitor OEV321UH (K220069)Olympus Medical Systems Corp.2022-03-09
SDC4K Information Management System with Device and Voice Control Package (K220108)Stryker Endoscopy2022-02-09
Connected OR Hub with Device and Voice Control (K212055)Stryker Corporation2021-12-16
ArtiSential Trocar (K212500)Livsmed, Inc.2021-12-03
FUJIFILM Video Laparoscope EL-R740M30 (K212950)Fujifilm Corporaton2021-12-02
SoftFix Balloon Trocar (K211577)Unimax Medical Systems, Inc.2021-11-05
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) (K212511)Stryker2021-11-04
RedEx (K211234)Advanced Surgical Concepts, Ltd.2021-09-17
HandX (K212214)Human Xtensions , Ltd.2021-09-13
Lab Bag with Fabric Pouch (K210248)Advanced Medical Design Co., Ltd.2021-07-30
Arthrex SynergyID Endoscopic Imaging System (K202582)Arthrex, Inc.2021-07-22
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (K203717)Fujifilm Corporaton2021-06-30
Cor-Knot Micro (K202551)Lsi Solutions, Inc.2021-06-24
VisionPort System (K211250)New View Surgical, Inc.2021-06-21
Port Access System (K210495)Surgical Innovations Limited2021-06-18
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (K210088)Stryker2021-04-13
SDC3 HD Information Management System with Wireless Device Control Capability (K210584)Stryker2021-03-18
4K UHD Laparoscope (K203255)Scivita Medical Technology Co., Ltd.2021-02-24
CORE E3 Suction/irrigator (K202303)Conmed Corporation2021-02-19
Monopolar Hook (K203603)Human Xtensions , Ltd.2021-02-01
TIPCAM1 Rubina Video Endoscope System (K201526)Karl Storz Endoscopy America2020-11-20
Disposable Trocar (K202931)Wuxi Shukang Medical Appliance Co., Ltd.2020-11-17
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (K202592)Stryker2020-10-08
Arthrex NanoScope System (K201134)Arthrex, Inc.2020-09-04
VersaOne Reusable Positioning Trocar System (K201805)Covidien2020-08-26
FUJIFILM Video Laparoscope (K202130)Fujifilm Corporation2020-08-20
Disposable Laparoscope Trocar (K201641)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2020-08-06
Cyber Blade (K192499)SIDAM S.r.l.2020-07-31
Connected OR Hub with Voice Control, Connected OR Hub with Device Control (K201434)Stryker2020-07-28
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable (K201198)Smith & Nephew2020-07-17
Disposable Specimen Retrieval Bag (K201243)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2020-07-10
GTK Trocars (K193272)Guangzhou T.K Medical Instrument Co., Ltd.2020-07-09
Looking Glass 4K Integrated Visualization System (K201593)Conmed Corporation2020-07-08
O-Mec 690 Series Laparoscopes (K201151)Omec Medical, Inc.2020-06-22
ClickClean (K200902)Medeon Biodesign, Inc.2020-04-30
GelPOINT Mini Advanced Access Platform (K191866)Applied Medical2020-04-29
Pristine Scope (K193161)Pristine Surgical2020-04-21
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (K200053)Dannik2020-04-21
7 mm Extended Length Endoscope (K191930)Maquet Cardiovascular, LLC2020-04-15
Standard Trocar (K200517)Standard Bariatrics2020-04-09
Visera Elite II Video System Center, Visera Elite II Endoeye 3D (K193026)Olympus Medical Systems Corp.2020-04-03
EnlightenVue Microendoscopy System (K192300)Enlightenvue, Inc.2020-03-20
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality (K200310)Stryker2020-03-06
Video Laparoscope, Video Processor, Light Source (K192918)Fujifilm Corporation2020-02-20
ClearCam System (K200228)Clearcam, LLC2020-02-19
Xenocor Articulating Xenoscope Laparoscope (K193315)Xenocor, Inc.2020-01-27
IP Converter (K191678)Sony Electronics, Inc.2020-01-10
EASYGRIP FLO-41 Precision MIS Delivery System (K193137)Baxter Healthcare Corportation2020-01-08
Dannik Laparoscopic Suction Irrigation System (K192643)Dannik2019-11-19
Laparoscope Lens Shield Device (LENS) (K192891)Medeon Biodesign, Inc.2019-11-07
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (K190029)Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2019-09-26
3D Visualization System (K183675)Scivita Medical Technology Co., Ltd.2019-09-25
Connected OR Hub with Device and Voice Control (K192172)Stryker2019-09-09
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (K191177)Smith and Nephew, Inc.2019-08-23
Percutaneous Introducer Needle (K191295)Progressive Medical, Inc.2019-08-06
Arthrex NanoScope System (K190645)Arthrex, Inc.2019-07-05
da Vinci Handheld Camera (K191043)Intuitive Surgical, Inc.2019-06-06
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor (K190831)Nanjing Jusha Display Technology Co., Ltd.2019-05-31
YelloPort Elite Port Access System (K190592)Surgical Innovations Limited2019-04-29
Disposable Standard Clamp (K190788)Standard Bariatrics2019-04-18
ELMED Laparoscopic Instruments and Accessories (K181173)Elmed Incorporated2019-03-22
Anchor Bag-Alone Tissue Retrieval System by ConMed (K183600)Conmed Corporation2019-03-13
Flex-THOR scope (K183264)KARL STORZ Endoscopy-America, Inc.2019-01-18
LaparoGuard (K182434)Mariner Endosurgery, Inc.2018-12-13
PINPOINT Endoscopic Fluorescence Imaging System (K182606)Novadaq Technologies Ulc. (Now A Part of Stryker)2018-11-21
neoClose PDS (K173917)Neosurgical, Ltd.2018-11-08
ConnectedOR Hub with Device and Voice Control (K181258)Stryker2018-11-05
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (K182160)Stryker2018-11-05
Disposable Standard Clamp (K181608)Standard Bariatrics2018-09-27
Scope Antifogging System (K182080)Xodus Medical, Inc.2018-09-19
Anchor Tissue Retrieval System by CONMED (K173822)Conmed Corporation2018-09-11
Dissecting Balloon System (K182024)Applied Medical Resources Corp.2018-08-30
SIMPLYSTRONG, SIMPLYEZEE (K181791)Genicon, Inc.2018-08-21
Universal Cannula Seal (5-12 mm) (K181395)Intuitive Surgical, Inc.2018-07-27
KARL STORZ New Generation Trocars (K180977)KARL STORZ Endoscopy-America, Inc.2018-07-18
Genistrong (K180836)Genicon, Inc.2018-04-18
Disposable Endoscopic Trocar (K180208)Fengh Medical Co., Ltd.2018-04-09
AEON Retrieval Bag (K180114)Lexington Medical, Inc.2018-03-27
HX Device (K173919)Human Extension , Ltd.2018-03-20
Ezee Retrieval (K180579)Genicon, Inc.2018-03-19
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