FDA Product Code EOQ: Bronchoscope (flexible Or Rigid)
FDA product code EOQ covers flexible and rigid bronchoscopes and their accessories.
These endoscopic instruments allow clinicians to directly visualize the airways — from the larynx to the segmental bronchi — for diagnostic and therapeutic purposes. They are used in the evaluation of lung lesions, foreign body removal, airway management, and bronchial lavage.
EOQ devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Olympus Medical Systems Corp. and Intuitive Surgical, Inc..
238
Total
238
Cleared
123d
Avg days
1976
Since
238 devices
Cleared
Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat
265d
Cleared
Sep 24, 2024
Ion Endoluminal System (IF 1000)
Intuitive Surgical, Inc.
Ear, Nose, Throat
70d
Cleared
May 31, 2024
BroncTru™ Transbronchial Access Tool
Broncus Medical, Inc.
Anesthesiology
277d
Cleared
May 01, 2024
MiiS Horus Bronchoscope
Medimaging Integrated Solution, Inc (Miis)
Ear, Nose, Throat
126d
Cleared
Apr 26, 2024
BioStar Single Use Transbronchial Aspiration Needle
Broncus Medical, Inc.
Anesthesiology
291d
Cleared
Apr 05, 2024
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat
130d
Cleared
Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
Intuitive Surgical, Inc.
Ear, Nose, Throat
76d
Cleared
Feb 15, 2024
Bronchoscope System
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat
302d
Cleared
Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
Fujifilm Healthcare Americas Corporation
Ear, Nose, Throat
28d
Cleared
Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Pentax of America, Inc.
Ear, Nose, Throat
125d
Cleared
Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
Pentax of America, Inc.
Ear, Nose, Throat
193d
Cleared
Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
Ambu A/S
Ear, Nose, Throat
50d
Cleared
Dec 18, 2023
Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
Ear, Nose, Throat
87d
Cleared
Nov 14, 2023
Broncho Videoscope System
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat
172d
Cleared
Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ambu A/S
Ear, Nose, Throat
26d
Cleared
Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Ambu A/S
Ear, Nose, Throat
174d
Cleared
Jun 15, 2023
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
Olympus Medical Systems Corporation
Ear, Nose, Throat
266d
Cleared
Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Ambu A/S
Ear, Nose, Throat
217d
Cleared
May 15, 2023
Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat
144d
Cleared
May 03, 2023
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
Verathon Medical (Canada) Ulc
Ear, Nose, Throat
29d
Cleared
Apr 11, 2023
Bronchoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Ear, Nose, Throat
197d
Cleared
Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
Boston Scientific Corporation
Anesthesiology
297d
Cleared
Mar 01, 2023
Galaxy System
Noah Medical Corp.
Ear, Nose, Throat
148d
Cleared
Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu A/S
Ear, Nose, Throat
27d