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

DateFirm and productCodeLinked 510(k)
Mar 3, 2026Olympus Corporation of the Americas
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent lea
Open, Classified
EOQK061313
Mar 3, 2026Olympus Corporation of the Americas
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflu
Open, Classified
EOQK061313
Feb 17, 2026Auris Health, Inc
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Open, Classified
EOQK193534
K211493 +1
Jan 21, 2026Intuitive Surgical, Inc.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platf
Open, Classified
EOQK212048
Nov 26, 2025Noah Medical Corporation
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of
Open, Classified
EOQK223144
Oct 16, 2025Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Open, Classified
EOQK250862
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Open, Classified
EOQK121959
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Open, Classified
EOQK050220
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
Open, Classified
EOQK061313
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Open, Classified
EOQK121959
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Open, Classified
EOQK250862
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Open, Classified
EOQK061313
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Open, Classified
EOQK121959
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Open, Classified
EOQK250862
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Open, Classified
EOQK061313
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Open, Classified
EOQK121959
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Open, Classified
EOQK121959
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Open, Classified
EOQK250862
Oct 16, 2025Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Open, Classified
EOQK023984
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Open, Classified
EOQK061313
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Open, Classified
EOQK023984
May 6, 2025Ambu Inc.
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Open, Classified
EOQK232582
Feb 11, 2025Olympus Corporation of the Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; M
Open, Classified
EOQK060243
Dec 20, 2024Noah Medical
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Open, Classified
EOQK223144
Dec 18, 2024Noah Medical
Galaxy System (GAL-001)
Open, Classified
EOQK223144
Dec 13, 2024Noah Medical
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Open, Classified
EOQK223144
Oct 10, 2024AURIS HEALTH INC
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Open, Classified
EOQK211493
Aug 23, 2024Intuitive Surgical, Inc.
Ion Endoluminal System, REF: 380748-65
Open, Classified
EOQK182188
May 1, 2024Noah Medical
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagn
Open, Classified
EOQK223144
Apr 3, 2024Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Open, Classified
EOQK954797
Jan 11, 2024Ambu Inc.
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Open, Classified
EOQK223299
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
Open, Classified
EOQK201758
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Open, Classified
EOQK201758
Dec 14, 2023Olympus Corporation of the Americas
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Open, Classified
EOQK981543
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Open, Classified
EOQK193534
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Open, Classified
EOQK193534
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Open, Classified
EOQK193534
Nov 17, 2023Aizu Olympus Co., Ltd.
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Open, Classified
EOQK981543
Nov 17, 2023Aizu Olympus Co., Ltd.
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Open, Classified
EOQK082720
K201300
Nov 17, 2023Aizu Olympus Co., Ltd.
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
Open, Classified
EOQK221631
Nov 17, 2023Aizu Olympus Co., Ltd.
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Open, Classified
EOQK981543
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Open, Classified
EOQK963033
Nov 17, 2023Aizu Olympus Co., Ltd.
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Open, Classified
EOQK061313
K183416 +1

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