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EOQ

241 FDA 510(k) clearances · Product code

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RecordFirmDate
Ambu 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 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor (K173727)Ambu A/S2018-03-28
Monarch Endoscopy Platform (Monarch Platform) (K173760)Auris Surgical Robotics, Inc.2018-03-22
Captura Disposable Bronchoscope Biopsy Forceps (K163377)Wilson-Cook Medical, Inc.2018-02-21
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope (K173554)Pentax of America, Inc.2018-01-19
FUJIFILM Bronchoscope Model EB-530P (K171291)Fujifilm Medical Systems U.S.A, Inc.2018-01-19
B7 2C Occlusion Balloon (K171492)Spiration, Inc.2017-11-20
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (K163537)Covidien, LLC2017-04-21
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248)Boston Scientific Corporation2017-03-27
PeriFLEX (K162611)Spiration, Inc.2017-02-09
Ambu 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 (K161656)Ambu A/S2016-09-01
Auris Robotic Endoscopy System (ARES) (K152319)Auris Surgical Robotics, Inc.2016-05-26
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) (K152466)Prosurg, Inc.2016-05-19
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151315)Boston Scientific Corporation2015-11-10
PENTAX Medical EKP-i5010 Video Processor with EB Family (K143727)Pentax of America, Inc.2015-10-29
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (K142934)Covidien2015-06-17
PulmoVia Working Channel (K150280)Sanovas, Inc.2015-06-11
GenCut Core Biopsy System (K142839)Covidien, LLC2015-04-29
Flexible 19G EBUS Needle (K142909)Spiration, Inc.2015-04-24
VIDEO BRONCHOSCOPE SYSTEM (K141366)Scholly Fiberoptic GmbH2014-12-17
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS (K131946)Pentax Medical Company2014-04-25
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) (K131028)Pentax Medical Company2014-04-10
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW (K130845)Ambu A/S2013-11-01
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) (K131234)Broncus Medical, Inc.2013-10-15
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER (K131401)Mercator Medsystems, Inc.2013-07-02
EVIS EXERA III VIDEO SYSTEM (K121959)Olympus Medical Systems Corp.2013-01-10
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H (K122535)Fujifilm Medical System U.S.A., Inc.2012-12-13
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US (K121035)Fujifilm Medical System U.S.A., Inc.2012-06-04
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES (K091768)Vision-Sciences, Inc.2009-08-03
DIAGNOSTIC CATHETER SYSTEM (K091250)Cardinal Health, Inc.2009-05-22
YIELD TISSUE SAMPLER (K090853)Broncus Technologies, Inc.2009-04-07
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 (K082720)Olympus Medical Systems Corporation2008-11-05
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK (K081518)Pentax Medical Company2008-09-05
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM (K071530)KARL STORZ Endoscopy-America, Inc.2007-08-24
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 (K071473)Superdimension, Ltd.2007-07-12
EVIS EXERA 180 SYSTEM (K061313)Olympus Medical Systems Corporation2006-08-31
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 (K060243)Olympus Medical Systems Corporation2006-06-23
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P (K050907)Fujinon, Inc.2005-05-19
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC (K050220)Olympus Medical Systems Corporation2005-02-10
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (K040940)Olympus Corporation2004-04-19
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 (K040018)Boston Scientific Corp2004-01-20
ENK FIBEROPTIC ATOMIZER SET (K031966)Cook, Inc.2003-10-16
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K033225)Olympus Optical Co., Ltd.2003-10-16
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (K022446)Aomori Olympus Co., Ltd.2003-03-28
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES (K023984)The Olympus Optical Co.2003-01-31
DUAL-LUMEN CATHETER (K024165)Bistech, Inc.2003-01-10
EB-1830T3, VIDEO BRONCHOSCOPE (K023376)Pentax Precision Instrument Corp.2002-10-16
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (K022546)Horizons Intl. Corp.2002-08-12
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM (K021344)Vision-Sciences, Inc.2002-05-24
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 (K013731)Gimmi GmbH2001-11-27
EXHALE PROBE (K013111)Broncus Technologies, Inc.2001-10-01
OLYMPUS SPRAY CATHETER PW-6C-1 (K012073)The Olympus Optical Co.2001-08-10
EXHALE RF PROBE (K011267)Broncus Technologies, Inc.2001-05-08
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 (K993900)Broncus Technologies, Inc.2000-01-28
PILLING WECK SURGICAL Y STENT FORCEPS (K990547)Pilling Weck, Inc.1999-04-27
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE (K983878)E. Benson Hood Laboratories, Inc.1999-01-29
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE (K984157)Wilson-Cook Medical, Inc.1998-12-08
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT (K983124)Mill-Rose Laboratory1998-10-30
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT (K983122)Mill-Rose Laboratory1998-10-30
LSVP INTERNATIONAL BIOPSY FORCEPS (K982983)Lsvp Intl., Inc.1998-09-29
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT (K981543)The Olympus Optical Co.1998-06-08
BRONCHIAL CATHETER SYSTEM (K980046)Broncus Technologies, Inc.1998-05-01
COMBICATH CATHETER (K974642)Plastimed Laboratoire Pharmaceutique1998-03-13
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH (K970107)Urohealth Systems, Inc.1997-11-18
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH (K963795)Vision-Sciences, Inc.1996-12-23
TBAN (K963252)Boston Scientific Corp1996-09-20
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES (K963033)Olympus America, Inc.1996-09-09
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) (K962485)Olympus America, Inc.1996-08-20
OLYMPUS B5-2C/B7-2C BALLOON CATHETER (K962901)Olympus America, Inc.1996-08-20
OLYPUS FG SERIES GRASPING FORCEPS (K962533)Olympus America, Inc.1996-08-09
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) (K962380)Olympus America, Inc.1996-08-09
OLYMPUS BASKET GRASPERS (K962367)Olympus America, Inc.1996-08-05
OLYMPUS FG-45/46-1 GRASPING FORCEPS (K962378)Olympus America, Inc.1996-08-02
OLYMPUS FB SERIES BIOPSY FORCEPS (K962555)Olympus America, Inc.1996-07-30
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (K962736)Mill-Rose Laboratory1996-07-29
KARL STORZ INTUBATION FIBERSCOPE (K961178)KARL STORZ Endoscopy-America, Inc.1996-05-14
MILL-ROSE BLIND MICROBIOLOGY BRUSH (K960880)Mill-Rose Laboratory1996-04-29
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS (K960791)KARL STORZ Endoscopy-America, Inc.1996-03-11
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY (K954797)KARL STORZ Endoscopy-America, Inc.1996-01-17
OPTUS BRONCHOSCOPES (K945268)Optus, Inc.1995-12-21
BRONCHOSCOPE (K954707)Fujinon, Inc.1995-11-22
SAUER ENDOSCOPE GUIDE AND INTUBATION AID (K954125)KARL STORZ Endoscopy-America, Inc.1995-10-06
DISTENDING DIVERTICULOSCOPE (K953596)KARL STORZ Endoscopy-America, Inc.1995-09-26
JEDMED LARYNGEAL SCOPE (K950925)Jedmed Instrument Co.1995-08-11
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING (K952081)KARL STORZ Endoscopy-America, Inc.1995-07-03
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE (K951826)KARL STORZ Endoscopy-America, Inc.1995-05-15
FB-18X, FIBER BRONCHOSCOPE (K951199)Pentax Precision Instrument Corp.1995-04-10
KARL STORZ STENT APPLICATOR FORCEPS (K950965)KARL STORZ Endoscopy-America, Inc.1995-03-31
RITE-BITE BIOPSY FORCEPS (K951051)Mill-Rose Laboratory1995-03-24
OLYMPUS BIOPSY FORCEPS MODEL FB-44 (K950786)Olympus America, Inc.1995-03-06
OLYMPUS DISPOSABLE BIOPSY FORCEPS (K950636)Olympus America, Inc.1995-02-27
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE (K931442)KARL STORZ Endoscopy-America, Inc.1995-01-24
BRONCHOSCOPE,NON-RIGID (K944976)Citation Medical Corp.1994-12-21
MILL-ROSE HARRELL BRONCHIAL BRUSH (K944649)Mill-Rose Laboratory1994-11-30
WANG BRONCHIAL NEEDLE BRUSH (K944650)Mill-Rose Laboratory1994-11-22
KARL STORZ BRONCHOSCOPE ACCESSORIES (K943700)KARL STORZ Endoscopy-America, Inc.1994-08-23
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE (K942388)Technology Marketing Group1994-08-17
RICHARD ROD LENS LARYNGOSCOPE (K941264)Smith & Nephew Richards, Inc.1994-07-18
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER (K940521)Mill-Rose Laboratory1994-05-04
FLEXIBLE GRASPING FORCEPS (K941161)Surgical Technologies, Inc.1994-05-04
FLEXIBLE BIOPSY CUP FORCEPS (K941158)Surgical Technologies, Inc.1994-04-28
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