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CAF

508 FDA 510(k) clearances · Product code

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RecordFirmDate
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM (K102454)Respironics Respiratory Drug Delivery (Uk) , Ltd.2011-10-25
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (K111570)Thayer Medical Corporation2011-09-29
COMP A-I-R (K110860)Omron Healthcare, Inc.2011-09-02
ATLANTEAN TRIGGER NEBULIZER (K102719)Atlantean Corporation2011-07-01
AEROVENT PLUS CHC (K110273)Monaghan Medical Corporation2011-06-09
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S (K103635)Aerogen, Ltd.2011-05-13
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 (K101552)Foshan Care Medical Technology Co., Ltd.2011-03-14
SMDIA-1000 (K101953)Southmedic, Inc.2011-01-07
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS (K102658)Thayer Medical Corp.2010-12-10
NIVO NEBULIZER SYSTEM (K102240)Aerogen Ireland, Ltd.2010-11-10
PHARMACARIBE INHALED SALINE SOLUTIONS (K101424)Pharmacaribe2010-08-17
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (K101857)Instrumentation Industries, Inc.2010-07-22
MERITS MODEL N SERIES NEBULIZER COMPRESSORS (K092859)Merits Health Products Co., Ltd.2010-07-02
LITETOUCH MASK (K100285)Respironics New Jersey, Inc.2010-06-29
PARI SINUS (K092560)Pari Respiratory Equipment, Inc.2010-05-06
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 (K100380)Pari Respiratory Equipment, Inc.2010-02-22
PARI VIOS (K092918)Pari Respiratory Equipment, Inc.2010-02-04
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 (K091794)Steve Islava2010-01-28
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC (K091111)Instrumentation Industries, Inc.2009-12-02
AKITA JET (K090730)Activaero America, Inc.2009-11-13
BESMED JET NEBULIZER BOTTLE SET (K091272)Besmed Health Business Corp2009-11-10
SMARTTRACK SYSTEM (K091803)Nexus6, Ltd.2009-10-09
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (K083256)K-Jump Health Co., Ltd.2009-06-26
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (K090840)Ventlab Corp.2009-06-25
DDI ULTRASONIC NEBULIZER SYSTEM (K090307)Diagnostic Devices, Inc.2009-06-18
AEROCHAMBER MINI VENTILATION CHAMBER (K090065)Trudell Medical Intl.2009-04-09
NEVONI CLASSIC, MODEL 6600-PO (K082878)Nsr Comercio E Representacoes Ltda2008-12-30
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM (K082541)Medi Nuclear Corp., Inc.2008-11-26
AERONEB GO NEBULIZER (K081650)Aerogen (Ireland), Ltd.2008-10-23
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 (K081738)Health & Life Co., Ltd.2008-09-17
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS (K082009)Hsiner Co., Ltd.2008-08-22
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (K080926)Trudell Medical Intl.2008-08-12
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 (K080969)Medi Nuclear Corp., Inc.2008-07-25
ULTRASONIC NEBULISER MODEL 2010 (K072136)Wilfred Kromker GmbH2008-07-15
NEB-90 LARGE VOLUME MEDICATION NEBULIZER (K080657)Medi Nuclear Corp., Inc.2008-06-30
NEB-U-MASK SYSTEM, MODELS 1895, 1896 (K080230)Teleflexmedical, Inc.2008-06-09
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 (K072163)3A Health Care S.R.L.2008-03-06
AG-CLASSIC (K072494)Medel S.P.A.2008-02-12
AEROSOL SYSTEM (K063716)Amici, Inc.2007-12-28
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER (K072670)Pari Innovative Manufacturers, Inc.2007-12-13
FUNHALER, MODEL V-201E (K072822)Infamed , Ltd.2007-11-26
AKITA2 APIXNEB (K072019)Activaero America, Inc.2007-11-05
AMSURE NEBULIZER (K070411)Amsino International, Inc.2007-10-01
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER (K072418)Respironics New Jersey, Inc.2007-09-12
AIRLIFE NEBULIZER CAP (K072119)Cardinalhealth2007-08-10
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS (K062484)Flaem Nuova S.P.A.2007-06-08
APEX MEDICAL MOBINEB, 9R-027 SERIES (K070990)Apex Medical Corp.2007-05-18
AERONEB PROFESSIONAL NEBULIZER SYSTEM (K070642)Aerogen (Ireland), Ltd.2007-05-07
HYPER SAL (K070498)Pari Innovative Manufacturers, Inc.2007-04-26
HSINER NEBULIZER BOTTLE (K070948)Hsiner2007-04-25
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB (K062014)Flaem Nuova S.P.A.2007-03-22
DELUXE NEBULIZER (K063449)Access Point Medical, LLC2007-03-01
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 (K062263)Omron Healthcare, Inc.2007-02-23
C300 SERIES AIR NEBULIZER COMPRESSOR (K062952)Choice Smart Health Care Co. , Ltd.2007-02-21
SIDESTREAM PLUS (K062689)Respironics , Ltd.2007-02-16
AG-EDGE, MODEL 91200 (K063103)Medel S.P.A.2007-01-08
DPILOG, MODEL DPC-512 (K062811)Life Outcomes, Inc.2006-12-20
LC SPRINT STAR (K062158)Pari Innovative Manufacturers, Inc.2006-08-28
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER (K053490)Merits Health Products Co., Ltd.2006-07-24
BABYAIR (K060497)Promedic, Inc.2006-07-11
AG-PLUS, MODEL 91210 (K060404)Medel S.P.A.2006-06-22
REVJET TURBO (K060842)Promedic, Inc.2006-06-21
LC STAR WITH NASAL ADAPTER (K061381)Pari Innovative Manufacturers, Inc.2006-06-02
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 (K060811)Omron Healthcare, Inc.2006-05-25
TREK S NEBULIZER COMPRESSOR (K060357)Pari Innovative Manufacturers, Inc.2006-04-05
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C (K053360)Aerovectrx Corporation2006-03-23
LC SPRINT NEBULIZER (K060399)Pari Innovative Manufacturers, Inc.2006-03-02
AEROECLIPSE II BREATH ACTUATED NEBULIZER (K053605)Trudell Medical Intl.2006-02-27
EMG HANDLE NEBULIZER NB02 SERIES (K052438)Emg Technology Co., Ltd.2006-01-31
HSINER JET NEBULIZER, MODEL HS-31100 (K052811)Hsiner Co., Ltd.2005-12-21
MYNEB NEBULIZER, MODEL RDD100 (K053203)Respironics New Jersey, Inc.2005-12-20
I-NEB INSIGHT AAD SYSTEM (K052941)Profile Therapeutics Plc2005-12-09
I-NEB AAD SYSTEM (K042991)Profile Therapeutics Plc2005-09-23
SCHUCO MIST AND SCHUCO DELUXE MIST (K051260)Allied Healthcare Products, Inc.2005-09-15
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES (K050183)Silvestrin Fabris S.R.L.2005-08-16
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 (K051365)K-Jump Health Co., Ltd.2005-07-22
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES (K043238)Emg Technology Co., Ltd.2005-07-06
MD TURBO (K051284)Respirics, Inc.2005-06-22
APEX MEDICAL MININEB & MINIPLUS (K050104)Apex Medical Corp.2005-02-16
INVACARE PRO, COMPACT AND PORTABLE DESKTOP (K042483)Invacare Corporation2005-01-06
FUNHALER, MODEL FH 101 (K042546)Infamed , Ltd.2005-01-03
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 (K042655)Respironics New Jersey, Inc.2004-10-13
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 (K041079)Guan Hong Enterprise Co., Ltd.2004-09-28
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (K041082)Newport Medical Instruments, Inc.2004-09-07
SHINMED MODE SW-988 UNTRASONIC NEBULIZER (K031370)Shining World Health Care Co., Ltd.2004-09-01
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES (K041327)Med2000 S.R.L.2004-07-20
MDI TRIGGER GUARD (K040439)North American Technical Services (Nats) Corp.2004-07-08
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER (K041418)Cardinalhealth2004-06-10
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (K032170)Medical Industries America, Inc.2004-05-28
OMNI~NEB; OMNI~MAX (K030396)B&B Medical Technologies, Inc.2004-05-07
EFLOW ELECTRONIC INHALER/NEBULIZER (K033833)Pari Innovative Manufacturers, Inc.2004-05-05
PRODOSE AAD SYSTEM (K030747)Profile Therapeutics Plc2004-04-22
BIRDSONG LEVERHALER, MODEL LH-1000 (K031982)Birdsong Medical Devices, Inc.2004-04-02
TRUST (K040718)Dhd Healthcare Corp.2004-04-02
HIOX80 AEROSOL ADAPTER (K032516)Sensor Medics Corp.2004-03-04
AEROCHAMBER MAX VALVED HOLDING CHAMBER (K032972)Trudell Medical Intl.2004-01-14
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) (K031908)Med2000 S.R.L.2004-01-14
AERONEB GO NEBULIZER, MODEL AG-AG2000 (K032849)Aerogen, Inc.2003-11-21
HOSPITAL SPACER (K032809)Respironics Healthscan, Inc.2003-11-13
SONIK LDI 20 AIR (K030374)Evit Labs, Inc.2003-08-25
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