Tube, Tracheal (W/Wo Connector)

FDA product code BTR · 236 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5730
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1976-11-19 – 2026-09-03

BTR 2026-09-03

Tenax® Laser Resistant Endotracheal Tube

Applicant Bryan Medical, Inc.

K number K251794

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BTR 2026-06-12

Spiro-VISTA

Applicant Spiro Robotics

K number K253437

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BTR 2025-10-06

Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

Applicant Covidien, LLC

K number K250173

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BTR 2025-09-25

Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

Applicant Covidien, LLC

K number K243785

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BTR 2025-08-13

AeroJet Ventilation Catheter

Applicant Pipeline Medical Products, LLC

K number K243579

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BTR 2025-06-11

Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

Applicant William Cook Europe Aps

K number K251499

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BTR 2025-05-20

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

Applicant Flexicare Medical Limited.

K number K250243

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BTR 2025-04-29

LMA Fastrach ETT SU

Applicant Teleflex Medical

K number K242495

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BTR 2025-02-11

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

Applicant Teleflex Incorporated

K number K241451

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BTR 2024-05-20

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Applicant Covidien, LLC

K number K233341

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BTR 2023-08-30

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

Applicant Covidien

K number K223130

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BTR 2022-07-21

Wei Nasal Jet Tube

Applicant Well Lead Medical Co., Ltd.

K number K211543

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BTR 2021-10-21

Tenax Laser Resistant Endotracheal Tube

Applicant Bryan Medical, Inc.

K number K213028

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BTR 2020-11-25

Tenax Laser Resistant Endotracheal Tube

Applicant Bryan Medical, Inc.

K number K200761

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BTR 2020-02-14

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

Applicant Venner Medical (Singapore) Pte, Ltd.

K number K192120

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BTR 2020-01-10

Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff

Applicant Salter Labs, Inc.

K number K190878

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BTR 2019-12-11

Endotracheal Tube with Evacuation Lumen

Applicant Well Lead Medical Co., Ltd.

K number K182739

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BTR 2019-12-06

Sheridan Spiral-Flex Endotracheal Tubes

Applicant Teleflexmedical, Inc.

K number K192324

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BTR 2019-10-09

SolidAIRity III Airway Stabilization System

Applicant Securisyn Medical, LLC

K number K190630

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BTR 2019-09-06

Yikang Endotracheal Tube

Applicant Jiangxi Yikang Medical Instrument Group Co., Ltd.

K number K190213

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BTR 2019-07-30

Endotracheal Tube

Applicant Tianjin Medis Medical Device Co., Ltd.

K number K190274

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BTR 2018-11-29

VivaSight-SL (TVT) system

Applicant Etview , Ltd.

K number K181880

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BTR 2018-04-23

Frova Intubating Introducer

Applicant Cook Incorporated

K number K171917

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BTR 2018-02-16

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet

Applicant Nevap, Inc.

K number K172208

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BTR 2018-01-17

Endotracheal tube; Reinforced Endotracheal tube

Applicant Zhanjiang Star Enterprise Co., Ltd.

K number K170234

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BTR 2018-01-12

IRRIS (Infra-Red-Red Intubation System)

Applicant A.R Guide IN Medical , Ltd.

K number K171411

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BTR 2017-05-19

Frova Intubating Introducer

Applicant William Cook Europe Aps

K number K161813

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BTR 2017-04-07

Disposable Endotracheal tube, sterile, AccuCuff

Applicant Tianjin Medis Medical Device Co., Ltd.

K number K160694

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BTR 2016-02-25

ETView VivaSight-SL (TVT) system

Applicant Etview , Ltd.

K number K152438

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BTR 2013-08-20

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE

Applicant Kimberly-Clark Corp.

K number K131254

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BTR 2012-12-19

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING

Applicant Kimberly-Clark Corp.

K number K120985

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BTR 2012-07-19

BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K number K111406

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BTR 2012-07-19

BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K number K111401

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BTR 2012-06-21

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))

Applicant Etview , Ltd.

K number K121028

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BTR 2012-05-11

KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS

Applicant Kimberly-Clark Corporation

K number K113333

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BTR 2011-11-18

AMBU ASCOPE 2

Applicant Ambu A/S

K number K110962

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BTR 2011-08-26

WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL

Applicant Well Lead Medical Co., Ltd.

K number K110269

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BTR 2010-06-03

PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

Applicant Parkermedicalinc

K number K100546

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BTR 2010-04-16

AMBU ASCOPE AND MONITOR

Applicant Ambu A/S

K number K093186

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BTR 2010-04-02

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

Applicant Venner Medical (Singapore) Pte, Ltd.

K number K093135

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BTR 2009-10-29

TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT

Applicant Teleflexmedical, Inc.

K number K091761

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BTR 2009-08-04

EZC MEDICAL, LLC INTUBAIDFLEX

Applicant Ezc Medical, LLC

K number K090777

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BTR 2009-06-26

PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

Applicant Smiths Medical Asd, Inc.

K number K083119

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BTR 2009-06-17

FLEXICARE MEDICAL ENDOTRACHEAL TUBES

Applicant Flexicare Medical, Ltd.

K number K091591

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BTR 2009-04-28

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V

Applicant Clarus Medical, LLC

K number K082038

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BTR 2009-04-03

TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES

Applicant Covidien

K number K090352

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BTR 2009-02-13

ENDOTRACHEAL TUBE

Applicant Chilecom Medical Devices Co., Ltd.

K number K080105

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BTR 2008-10-27

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)

Applicant Medsource International, LLC

K number K080339

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BTR 2008-10-08

TRACHEOSCOPIC VENTILATION TUBE (TVT)

Applicant Etview

K number K082420

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BTR 2008-10-02

SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES

Applicant Mallinckrodt Medical

K number K082520

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BTR 2008-08-13

PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0

Applicant Smiths Medical Asd, Inc.

K number K081086

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BTR 2008-07-10

WELL LEAD REINFORCED ENDOTRACHEAL TUBE

Applicant Well Lead Medical Instruments

K number K073383

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BTR 2008-04-22

MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE

Applicant Kimberly-Clark Corp.

K number K080821

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BTR 2008-03-25

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)

Applicant C.R. Bard, Inc.

K number K080170

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BTR 2007-11-06

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE

Applicant C.R. Bard, Inc.

K number K071365

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BTR 2006-05-08

ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES

Applicant Arcadia Medical Corporation

K number K060094

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BTR 2005-12-13

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM

Applicant Etview , Ltd.

K number K052233

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BTR 2005-12-13

LMA FASTRACH ETT SINGLE USE

Applicant The Laryngeal Mask Co., Ltd.

K number K051993

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BTR 2005-07-15

AMSINO ENDOTRACHEAL TUBE

Applicant Amsino International, Inc.

K number K050785

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BTR 2005-06-30

PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES

Applicant Vitaid, Ltd.

K number K050803

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BTR 2005-03-18

TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)

Applicant Tiger Medical Products, Ltd.

K number K041311

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BTR 2005-02-18

WELL LEAD ENDOTRACHEAL TUBE

Applicant Well Lead Medical Instruments

K number K042683

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BTR 2005-01-07

RUSCH EASY TUBE

Applicant Teleflex Medical

K number K043205

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BTR 2005-01-07

PLASIATEK ACTUATOR

Applicant Plasiatek, LLC

K number K041917

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BTR 2004-06-10

BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80

Applicant Vygon SA

K number K040657

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BTR 2004-03-12

ENDOFLEX TRACHEAL TUBE

Applicant Merlyn Associates, Inc.

K number K031794

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BTR 2004-01-26

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

Applicant Portex , Ltd.

K number K032112

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BTR 2003-11-14

BARD ENDOTRACHEAL TUBE, CUFFED

Applicant C.R. Bard, Inc.

K number K030792

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BTR 2002-12-23

RUSCH MICROLARYNGEAL TUBE

Applicant Rusch Intl.

K number K023964

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BTR 2002-09-11

MADETT

Applicant Wolfe Tory Medical, Inc.

K number K021044

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BTR 2002-08-01

RUSCH EDGAR TUBE

Applicant Rusch Intl.

K number K021540

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BTR 2002-06-04

SILICONE TRACHEAL T-TUBES

Applicant Technical Products, Inc.

K number K013321

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BTR 2000-03-15

POSITUBE

Applicant Paraproducts, Inc.

K number K000045

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BTR 2000-02-04

ILM ENDOTRACHEAL TUBE

Applicant The Laryngeal Mask Co., Ltd.

K number K991580

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BTR 2000-02-02

RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY

Applicant Rusch Intl.

K number K993786

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BTR 2000-01-20

MODIFICATION TO LASER-SHIELD II

Applicant Xomed, Inc.

K number K993582

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BTR 1999-08-03

RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE

Applicant Rusch Intl.

K number K990619

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BTR 1999-07-15

PARKER FLEX-TIP TRACHEAL TUBE

Applicant Parker Medical Assoc.

K number K984528

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BTR 1999-03-26

ESOPHAGEAL INTUBATION DETECTOR

Applicant Wolfe Tory Medical, Inc.

K number K990556

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BTR 1999-02-11

VENTLAB VERIFY II

Applicant Ventlab Corp.

K number K990098

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BTR 1998-07-17

AMBU TUBECHECK

Applicant Ambu, Inc.

K number K981891

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BTR 1998-03-02

MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER

Applicant Green Field Medical Sourcing, Inc.

K number K971759

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BTR 1998-02-13

THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM

Applicant Pulmonx

K number K973191

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BTR 1997-08-21

T-WALL UNCUFFED TRACHEAL TUBE

Applicant Vital Signs, Inc.

K number K970196

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BTR 1997-03-20

HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

Applicant Mallinckrodt Medical

K number K965132

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BTR 1996-11-21

EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE

Applicant Unomedical Sdn Bhd

K number K962389

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BTR 1996-10-08

ESOPHAGEAL INTUBATION DETECTOR

Applicant Kirk Specialty Systems

K number K962098

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BTR 1996-08-16

RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

Applicant Rusch Intl.

K number K961837

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BTR 1996-06-27

RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY

Applicant Rusch Intl.

K number K961840

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BTR 1996-06-27

RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE

Applicant Rusch, Inc.

K number K955495

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BTR 1996-05-22

VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE

Applicant Vygon Corp.

K number K960795

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BTR 1996-05-10

RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE

Applicant Rusch Intl.

K number K954585

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BTR 1996-04-19

HEBELER SAFE-T-TUBE

Applicant Boston Medical Products, Inc.

K number K960450

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BTR 1995-12-15

TEVES ECM PLUS THERMOCOUPLE

Applicant Advanced Medical Concepts, Inc.

K number K951768

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BTR 1995-12-08

WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE

Applicant Unomedical Sdn Bhd

K number K954754

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BTR 1995-12-08

PEDIATRIC SILICONE ENDOTRACHEAL TUBE

Applicant Unomedical Sdn Bhd

K number K954753

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BTR 1995-12-08

SILICONE ENDOTRACHEAL TUBE

Applicant Unomedical Sdn Bhd

K number K954751

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BTR 1995-12-08

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE

Applicant Unomedical Sdn Bhd

K number K954750

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BTR 1995-09-18

LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES

Applicant Karl Storz Endoskop GmbH

K number K953368

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BTR 1995-05-23

RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE

Applicant Rusch, Inc.

K number K935842

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