ClearanceBrief
Panels › Ear, Nose, Throat › Product code EOQ · Class 2

Bronchoscope (Flexible Or Rigid)

Regulation 874.4680

11510(k)s in 12 months (244 all time)
5recalls in 12 months (160 all time)
158recalls that name a 510(k)
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Top companies in EOQ

Company510(k)sRecalls
Olympus Corporation of the Americas0100
Olympus Medical Systems Corp.190
Intuitive Surgical116
Pentax of America, Inc.95
KARL STORZ Endoscopy-America, Inc.130
Ambu A/S110
Mill-Rose Laboratory110
Auris Health, Inc.46
Olympus America, Inc.100
Aomori Olympus Co., Ltd.18
Decided510(k)Device and applicantCode
Apr 11, 2023K222910Bronchoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
EOQ
Mar 2, 2023K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
Boston Scientific Corporation
EOQ
Mar 1, 2023K223144Galaxy System
Noah Medical Corp.
EOQ
Jan 12, 2023K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu A/S, DK
EOQ
Dec 21, 2022K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
Pentax of America, Inc.
EOQ
Nov 10, 2022K220957FUJIFILM Endoscope Model EB-710P
Fujifilm Corporaton, JP
EOQ
Sep 26, 2022K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
Olympus Medical Systems Corp., JP
EOQ
Aug 15, 2022K221302Recon Steerable Sheath
Serpex Medical, Inc.
EOQ
Jul 28, 2022K222014EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation
EOQ
Jul 25, 2022K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Ambu A/S, DK
EOQ
Jul 8, 2022K213782Single-Use Video Bronchoscopes, Digital Controller
Micro-Tech (Nanjing) Co., Lts, CN
EOQ
Jun 16, 2022K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
OTU Medical, Inc.
EOQ
Jun 16, 2022K220299Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Feb 28, 2022K213635Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Feb 16, 2022K212886Broncoflex Agile, Broncoflex Vortex, Screeni
Axess Vision Technology, FR
EOQ
Dec 29, 2021K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)
Karl Storz Endoscopy America
EOQ
Nov 24, 2021K211169Bronchoscope System
Shanghai AnQing Medical Instrument Co., Ltd., CN
EOQ
Nov 3, 2021K211947GlideScope BFlex 2.8 Single-Use Bronchoscope
Verathon Medical (Canada) Ulc, CA
EOQ
Oct 21, 2021K210928PENTAX Medical Video Bronchoscope EB11-J10
Pentax of America, Inc.
EOQ
Sep 22, 2021K212667Single Use Guide Sheath Kit-401, K-402
Olympus Medical Systems Corp., JP
EOQ
Aug 26, 2021K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
Intuitive Surgical, Inc.
EOQ
Aug 9, 2021K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use
Boston Scientific Corporation
EOQ
Jul 28, 2021K210379Broncho Videoscope System
Scivita Medical Technology Co., Ltd., CN
EOQ
Jul 9, 2021K211493Monarch Platform
Auris Health, Inc.
EOQ
Jun 17, 2021K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
Ambu A/S, DK
EOQ
Apr 29, 2021K202987Rescue Pulmonary Grasping Forceps
Anrei Medical (Hangzhou) Co., Ltd., CN
EOQ
Feb 19, 2021K202346SPiN Vision Video Bronchoscope System
Veran Medical Technologies, Inc.
EOQ
Jan 26, 2021K201300Airway Mobilescope
Olympus Medical Systems Corp., JP
EOQ
Jan 21, 2021K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
Olympus Medical Systems Corp., JP
EOQ
Jan 14, 2021K200702EasyPath RF Introducer Sheath
Broncus Medical, Inc.
EOQ
Dec 17, 2020K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Us
Olympus Medical Systems Corp., JP
EOQ
Nov 16, 2020K202370Ion Endoluminal System
Intuitive Surgical, Inc.
EOQ
Oct 22, 2020K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Referen
Axess Vision Technology, FR
EOQ
Jul 30, 2020K200678PENTAX Medical Video Bronchoscope EB-J10 Series
Pentax of America, Inc.
EOQ
Jun 26, 2020K201146Ion Endoluminal System
Intuitive Surgical, Inc.
EOQ
Apr 24, 2020K200397Single Use Biopsy Forceps FB-456D
Olympus Medical Systems Corp., JP
EOQ
Apr 15, 2020K193534Monarch Platform
Auris Health, Inc.
EOQ
Mar 6, 2020K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
Olympus Medical Systems Corp., JP
EOQ
Feb 13, 2020K191828Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Jan 16, 2020K193488GlideScope BFlex 3.8 Single-Use Bronchoscope
Verathon Medical (Canada) Ulc, CA
EOQ
Nov 26, 2019K192367Ion Endoluminal System
Intuitive Surgical, Inc.
EOQ
Sep 6, 2019K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Pentax of America, Inc.
EOQ
Sep 5, 2019K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190
Olympus Medical Systems Corp., JP
EOQ
Aug 23, 2019K183607FUJIFILM Bronchoscope
Fujifilm Corporation, JP
EOQ
Aug 21, 2019K191948GlideScope BFlex 5.8 Single-Use Bronchoscope
Verathon Medical (Canada) Ulc, CA
EOQ
May 23, 2019K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
Pentax of America, Inc.
EOQ
Apr 4, 2019K182253FUJIFILM Video Bronchoscopes
Fujifilm Corporation, JP
EOQ
Mar 8, 2019K183085CoreDx™ Pulmonary Mini-Forceps
Boston Scientific Corporation
EOQ
Feb 22, 2019K182825FUJIFILM Ultrasonic Endoscope
Fujifilm Corporation, JP
EOQ
Feb 14, 2019K182188Ion Endoluminal System ; Flexision Biopsy Needle
Intuitive Surgical
EOQ

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