Panels › Anesthesiology › Product code CAF · Class 2
Nebulizer (Direct Patient Interface)
Regulation 868.5630
4510(k)s in 12 months (509 all time)
0recalls in 12 months (36 all time)
25recalls that name a 510(k)
Top companies in CAF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2011 | K112564 | QUIXIE NEBULIZER Odyssey Medical Technologies | CAF |
| Oct 25, 2011 | K102454 | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM Respironics Respiratory Drug Delivery (Uk) , Ltd. | CAF |
| Sep 29, 2011 | K111570 | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR Thayer Medical Corporation | CAF |
| Sep 2, 2011 | K110860 | COMP A-I-R Omron Healthcare, Inc. | CAF |
| Jul 1, 2011 | K102719 | ATLANTEAN TRIGGER NEBULIZER Atlantean Corporation | CAF |
| Jun 9, 2011 | K110273 | AEROVENT PLUS CHC Monaghan Medical Corporation | CAF |
| May 13, 2011 | K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S Aerogen, Ltd., IE | CAF |
| Mar 14, 2011 | K101552 | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 Foshan Care Medical Technology Co., Ltd. | CAF |
| Jan 7, 2011 | K101953 | SMDIA-1000 Southmedic, Inc. | CAF |
| Dec 10, 2010 | K102658 | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS Thayer Medical Corp. | CAF |
| Nov 10, 2010 | K102240 | NIVO NEBULIZER SYSTEM Aerogen Ireland, Ltd., IE | CAF |
| Aug 17, 2010 | K101424 | PHARMACARIBE INHALED SALINE SOLUTIONS Pharmacaribe | CAF |
| Jul 22, 2010 | K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V Instrumentation Industries, Inc. | CAF |
| Jul 2, 2010 | K092859 | MERITS MODEL N SERIES NEBULIZER COMPRESSORS Merits Health Products Co., Ltd., TW | CAF |
| Jun 29, 2010 | K100285 | LITETOUCH MASK Respironics New Jersey, Inc. | CAF |
| May 6, 2010 | K092560 | PARI SINUS Pari Respiratory Equipment, Inc. | CAF |
| Feb 22, 2010 | K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 Pari Respiratory Equipment, Inc. | CAF |
| Feb 4, 2010 | K092918 | PARI VIOS Pari Respiratory Equipment, Inc. | CAF |
| Jan 28, 2010 | K091794 | CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 Steve Islava | CAF |
| Dec 2, 2009 | K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC Instrumentation Industries, Inc. | CAF |
| Nov 13, 2009 | K090730 | AKITA JET Activaero America, Inc. | CAF |
| Nov 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET Besmed Health Business Corp, TW | CAF |
| Oct 9, 2009 | K091803 | SMARTTRACK SYSTEM Nexus6, Ltd., NZ | CAF |
| Jun 26, 2009 | K083256 | ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 K-Jump Health Co., Ltd., TW | CAF |
| Jun 25, 2009 | K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. Ventlab Corp. | CAF |
| Jun 18, 2009 | K090307 | DDI ULTRASONIC NEBULIZER SYSTEM Diagnostic Devices, Inc. | CAF |
| Apr 9, 2009 | K090065 | AEROCHAMBER MINI VENTILATION CHAMBER Trudell Medical Intl., CA | CAF |
| Dec 30, 2008 | K082878 | NEVONI CLASSIC, MODEL 6600-PO Nsr Comercio E Representacoes Ltda | CAF |
| Nov 26, 2008 | K082541 | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM Medi Nuclear Corp., Inc. | CAF |
| Oct 23, 2008 | K081650 | AERONEB GO NEBULIZER Aerogen (Ireland), Ltd., IE | CAF |
| Sep 17, 2008 | K081738 | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 Health & Life Co., Ltd. | CAF |
| Aug 22, 2008 | K082009 | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS Hsiner Co., Ltd. | CAF |
| Aug 12, 2008 | K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER Trudell Medical Intl., CA | CAF |
| Jul 25, 2008 | K080969 | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 Medi Nuclear Corp., Inc. | CAF |
| Jul 15, 2008 | K072136 | ULTRASONIC NEBULISER MODEL 2010 Wilfred Kromker GmbH | CAF |
| Jun 30, 2008 | K080657 | NEB-90 LARGE VOLUME MEDICATION NEBULIZER Medi Nuclear Corp., Inc. | CAF |
| Jun 9, 2008 | K080230 | NEB-U-MASK SYSTEM, MODELS 1895, 1896 Teleflexmedical, Inc. | CAF |
| Mar 6, 2008 | K072163 | HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 3A Health Care S.R.L. | CAF |
| Feb 12, 2008 | K072494 | AG-CLASSIC Medel S.P.A. | CAF |
| Dec 28, 2007 | K063716 | AEROSOL SYSTEM Amici, Inc. | CAF |
| Dec 13, 2007 | K072670 | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER Pari Innovative Manufacturers, Inc. | CAF |
| Nov 26, 2007 | K072822 | FUNHALER, MODEL V-201E Infamed , Ltd. | CAF |
| Nov 5, 2007 | K072019 | AKITA2 APIXNEB Activaero America, Inc. | CAF |
| Oct 1, 2007 | K070411 | AMSURE NEBULIZER Amsino International, Inc. | CAF |
| Sep 12, 2007 | K072418 | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER Respironics New Jersey, Inc. | CAF |
| Aug 10, 2007 | K072119 | AIRLIFE NEBULIZER CAP Cardinalhealth | CAF |
| Jun 8, 2007 | K062484 | FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS Flaem Nuova S.P.A. | CAF |
| May 18, 2007 | K070990 | APEX MEDICAL MOBINEB, 9R-027 SERIES Apex Medical Corp., TW | CAF |
| May 7, 2007 | K070642 | AERONEB PROFESSIONAL NEBULIZER SYSTEM Aerogen (Ireland), Ltd., IE | CAF |
| Apr 26, 2007 | K070498 | HYPER SAL Pari Innovative Manufacturers, Inc. | CAF |
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