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

Decided510(k)Device and applicantCode
Jan 4, 2019K183256GlideScope BFlex Single-Use Bronchoscope System
Verathon Medical (Canada) Ulc, CA
EOQ
Apr 30, 2018K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
Olympus Medical Systems Corp., JP
EOQ
Apr 26, 2018K172955LungVision Tool
Bodyvision Medical , Ltd., IL
EOQ
Mar 28, 2018K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Bronc
Ambu A/S, DK
EOQ
Mar 22, 2018K173760Monarch Endoscopy Platform (Monarch Platform)
Auris Surgical Robotics, Inc.
EOQ
Feb 21, 2018K163377Captura Disposable Bronchoscope Biopsy Forceps
Wilson-Cook Medical, Inc.
EOQ
Jan 19, 2018K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video
Pentax of America, Inc.
EOQ
Jan 19, 2018K171291FUJIFILM Bronchoscope Model EB-530P
Fujifilm Medical Systems U.S.A, Inc.
EOQ
Nov 20, 2017K171492B7 2C Occlusion Balloon
Spiration, Inc.
EOQ
Apr 21, 2017K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Covidien, LLC
EOQ
Mar 27, 2017K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation
EOQ
Feb 9, 2017K162611PeriFLEX
Spiration, Inc.
EOQ
Sep 1, 2016K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
Ambu A/S, DK
EOQ
May 26, 2016K152319Auris Robotic Endoscopy System (ARES)
Auris Surgical Robotics, Inc.
EOQ
May 19, 2016K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
Prosurg, Inc.
EOQ
Nov 10, 2015K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation
EOQ
Oct 29, 2015K143727PENTAX Medical EKP-i5010 Video Processor with EB Family
Pentax of America, Inc.
EOQ
Jun 17, 2015K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
Covidien
EOQ
Jun 11, 2015K150280PulmoVia Working Channel
Sanovas, Inc.
EOQ
Apr 29, 2015K142839GenCut Core Biopsy System
Covidien, LLC
EOQ
Apr 24, 2015K142909Flexible 19G EBUS Needle
Spiration, Inc.
EOQ
Dec 17, 2014K141366VIDEO BRONCHOSCOPE SYSTEM
Scholly Fiberoptic GmbH, DE
EOQ
Apr 25, 2014K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
Pentax Medical Company
EOQ
Apr 10, 2014K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
Pentax Medical Company
EOQ
Nov 1, 2013K130845AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
Ambu A/S
EOQ
Oct 15, 2013K131234LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
Broncus Medical, Inc.
EOQ
Jul 2, 2013K131401BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
Mercator Medsystems, Inc.
EOQ
Jan 10, 2013K121959EVIS EXERA III VIDEO SYSTEM
Olympus Medical Systems Corp.
EOQ
Dec 13, 2012K122535FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
Fujifilm Medical System U.S.A., Inc.
EOQ
Jun 4, 2012K121035FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
Fujifilm Medical System U.S.A., Inc.
EOQ
Aug 3, 2009K091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
Vision-Sciences, Inc.
EOQ
May 22, 2009K091250DIAGNOSTIC CATHETER SYSTEM
Cardinal Health, Inc.
EOQ
Apr 7, 2009K090853YIELD TISSUE SAMPLER
Broncus Technologies, Inc.
EOQ
Nov 5, 2008K082720TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
Olympus Medical Systems Corporation
EOQ
Sep 5, 2008K081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
Pentax Medical Company
EOQ
Aug 24, 2007K071530KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
KARL STORZ Endoscopy-America, Inc.
EOQ
Jul 12, 2007K071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
Superdimension, Ltd.
EOQ
Aug 31, 2006K061313EVIS EXERA 180 SYSTEM
Olympus Medical Systems Corporation
EOQ
Jun 23, 2006K060243OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
Olympus Medical Systems Corporation
EOQ
May 19, 2005K050907FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
Fujinon, Inc.
EOQ
Feb 10, 2005K050220EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
Olympus Medical Systems Corporation
EOQ
Apr 19, 2004K040940BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
Olympus Corporation
EOQ
Jan 20, 2004K040018EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
Boston Scientific Corp
EOQ
Oct 16, 2003K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
Olympus Optical Co., Ltd.
EOQ
Oct 16, 2003K031966ENK FIBEROPTIC ATOMIZER SET
Cook, Inc.
EOQ
Mar 28, 2003K022446MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
Aomori Olympus Co., Ltd.
EOQ
Jan 31, 2003K023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
The Olympus Optical Co.
EOQ
Jan 10, 2003K024165DUAL-LUMEN CATHETER
Bistech, Inc.
EOQ
Oct 16, 2002K023376EB-1830T3, VIDEO BRONCHOSCOPE
Pentax Precision Instrument Corp.
EOQ
Aug 12, 2002K022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
Horizons Intl. Corp.
EOQ

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