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Anesthesiology

8,405 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (K151069)Spectra Medical Devices, Inc.2016-02-05
IntelliCuff (K150893)Hamilton Medical AG2016-01-29
Antistatic Compact Space Chamber (K143615)Medical Developments International Limited2016-01-26
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit (K151072)Solo-Dex, Inc.2016-01-22
SonarMed AirWave, Airway Monitoring System (K143042)Sonarmed, Inc.2016-01-22
POCKET NEB (K142541)Microvaper Devices2016-01-22
AirLife Infant Heated Wire Circuit (K151303)Care Fusion2016-01-21
Shape-HF Cardiopulmonary Testing System (K150888)Shape Medical Systems, Inc.2016-01-21
Carestation 620/650/650C (K151570)Datex-Ohmeda, Inc.2016-01-21
DeVilbiss DV6WM Wireless Modem (K152810)Devilbiss Healthcare, LLC2016-01-21
AirLife Infant Single Limb Heated Wire Circuit (K151959)Carefusion, Inc.2016-01-20
IQSense Flow Sensor Mouthpiece (K150515)Sdi Diagnostics, Inc.2016-01-12
Sapphire (K152356)Respironics, Inc.2016-01-08
cNEP Airway (DEN140024)Sommetrics2015-12-23
SERVO-U Ventilator System, SERVO-n Ventilator System (K151814)Maquet Critical Care AB2015-12-21
Deployable Oxygen Generation System-Smaill (DOGS-S) (K150930)Airsep Corporation2015-12-18
Breathing circuit bacterial/viral filter (K151498)Zhejiang Haisheng Medical Device Co., Ltd.2015-12-18
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (K151329)Sentec AG2015-12-17
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (K151381)Covidien2015-12-11
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube (K150603)Teleflexmedical, Inc.2015-11-27
Nox RIP Belts & Cables (K151361)Nox Medical Ehf2015-11-06
AirView (K151901)Resmed, Ltd.2015-11-05
SnoreSounds (K150102)Appian Medical, Inc.2015-11-05
A7 Anesthesia System (K151954)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-10-27
Aerobika OPEP Devive with Manometer (K150173)Trudell Medical International2015-10-15
AF541 SE Full Face Mask (K150638)Respironics, Inc.2015-09-18
AF541 EE Full Face Mask (K150639)Respironics, Inc.2015-09-18
DeVilbiss Intellipap2/DeVilbiss BLUE (K143677)Devilbiss Healthcare, LLC2015-09-18
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (K150111)Apex Medical Corp.2015-09-15
HAMILTON-T1,HAMILTON-C1 (K140939)Hamilton Medical AG2015-09-02
Skynector CPAP Mask (K150685)Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.2015-08-24
Vyntus / SentrySuite Product Line (K150810)Carefusion Germany 234 GmbH2015-08-14
Disposable Pressure Manometer (DPM) (K143148)Westmed, Inc.2015-08-11
CPAP Cannulaide (K143700)Salter Labs2015-08-05
CoSense ETCO Monitor (K151107)Capnia, Inc.2015-07-22
Cloud9 System (K150365)Insleep Technologies, LLC2015-07-21
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245)GE Healthcare Finland Oy2015-07-17
Capnostream 35 Portable Respiratory Monitor (K150272)Oridion Medical 1987 , Ltd.2015-07-17
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (K150844)Covidien2015-07-14
Aeroneb USB Contoller System (K143719)Aerogen Limited2015-07-10
INOmax DSIR Plus MRI (K143213)Ino Therapeutics/Ikaria2015-07-10
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (K142764)Hangzhou Jinlin Medical Appliances Co., Ltd.2015-07-09
V60 Anesthetic Vaporizer (K150167)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-06-30
Besmed Reusable Jet Nebulizer (K150591)Besmed Health Business Corp2015-06-30
Vitalograph Model 6600 Compact (K142642)Vitalograph (Ireland) , Ltd.2015-06-30
Vitalograph Model 6800 Pneumotrac (K142812)Vitalograph (Ireland) , Ltd.2015-06-29
Arrow Epidural Catheter Kit (K143581)Teleflexmedical, Inc.2015-06-26
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX (K120577)Medikro OY2015-06-24
Propeller Model 2014-D Sensor (K143671)Reciprocal Labs2015-06-19
CARESCAPE R860 (K142679)Datex-Ohmeda, Inc.2015-06-12
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM (K141943)Breathe Technologies2015-06-12
Remington Medical Inc. Tuohy Epidural Needles (K150266)Remington Medical, Inc.2015-06-04
ACCU-CHEK Connect Diabetes Management App (K150910)Roche Diabetes Care, Inc.2015-06-03
SpiroThor (K150137)Cohero Health, LLC2015-05-27
Darlinghurst Vented, Darlinghurst NV-AAV (K143603)Resmed, Ltd.2015-05-21
Intelli-Ox (K143060)Air Liquide Healthcare2015-05-21
GMX Series Medical Air/Oxygen Blender (K142291)Gentec (Shanghai) Corporation2015-05-19
Propeller System (K142516)Reciprocal Labs Corporation2015-05-15
Flexicare Heated Wire Breathing Systems (K150900)Flexicare Medical, Ltd.2015-05-15
CUFF PILOT, SURE SEAL (K142103)Teleflexmedical, Inc.2015-05-08
The Vest Airway Clearance System (K142482)Hill-Rom Services Private Limited2015-05-07
ApneaLink Air (K143272)Resmed Germany, Inc.2015-04-30
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML (K142153)Teleflexmedical, Inc.2015-04-29
EndoTool SubQ (K142918)Monarch Medical Technologies2015-04-24
Aespire View (K143530)Datex-Ohmeda, Inc.2015-04-24
LUNA CPAP AND AUTO-CPAP SYSTEM (K141770)3B Medical, Inc.2015-04-22
RHINOGUARD (K141747)Davis Medical2015-04-20
OXYTOTE INFINITY SERIES VIPR SYSTEMS (K142149)Western/Scott Fetzer Co.2015-04-17
RUSCH ENDOBRONCHIAL TUBES (K141888)Teleflexmedical, Inc.2015-04-15
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET (K140110)Teleflex, Inc.2015-03-27
MiniStim MS-IVB Peripheral Nerve Stimulator (K143095)Halyard Health, Inc.2015-03-24
BigEasy Non-Rebreathing Valve (K142402)12th Man Technologies, Inc.2015-03-23
O-TWO E700,O-TWO E600,O-TWO E500 (K141595)O-Two Medical Technologies, Inc.2015-03-16
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (K141929)Roche Diagnostics Corporation2015-03-16
PULMONE MINIBOXPFT 2.0 (K141793)Pulmone Advanced Medical Devices, Ltd.2015-03-06
Propeller System 2014-R (K142960)Reciprocal Labs2015-03-05
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (K143646)Fisher & Paykel Healthcare, Ltd.2015-03-05
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula (K142296)Covidien2015-02-24
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff (K142298)Covidien2015-02-13
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style (K143127)Dispo-Med (Malaysia) Sdn Bhd2015-02-13
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF (K141087)Intersurgical Incorporated2015-02-12
SOFTECH Plus ETCO2 Cannula (K143469)Teleflexmedical, Inc.2015-02-12
TI NASAL MASK (K140980)Respironics, Inc.2015-02-10
CO2 monitoring line with and without in-line filter (K143150)Besmed Health Business Corp2015-02-05
ENGSTROM CARESTATION, ENGSTROM PRO (K140575)Datex-Ohmeda, Inc.2015-02-03
SOMNOTOUCH RESP (K140861)Somnomedics GmbH2015-01-30
A7 Anesthesia System (K142552)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-01-23
REVOLUTION FULLFACE MASK (K140580)Respironics Inc. (Dba Philips Respironics)2015-01-16
NEONATALIE RESUSCITATOR (K132172)Laerdal Medical A/S2015-01-15
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (K142553)Unisis Corp.2015-01-14
FOX MOBILE (K142059)Vectura GmbH2015-01-09
Revolution Full Face Mask (K142554)Respironics, Inc.2015-01-09
DISPOSABLE NEBULIZER SET (K140237)Suzhou Weikang Medical Apparatus Co., Ltd.2015-01-08
MADM (K140264)Thornhill Research, Inc.2015-01-05
MICROBLAB, MICROLOOP (K141936)Carefusion Germany 234 GmbH2014-12-29
Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (K140387)The Surgeon General, Department of the Army2014-12-23
AEROSURE MEDIC (K140772)Actegy , Ltd.2014-12-19
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS (K141214)Teleflexmedical, Inc.2014-12-18
DISPOSABLE TRACHEAL TUBE (K140228)Suzhou Weikang Medical Apparatus Co., Ltd.2014-12-18
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (K143164)Kimberly-Clark Corporation2014-12-02
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