ClearanceBrief
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)
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Top companies in CAF

Company510(k)sRecalls
Airlife, Inc.160
Aerogen Limited94
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company013
Vortran Medical Technology 1, Inc.120
Salter Labs92
Thayer Medical Corp.92
Adherium (Nz), Ltd.100
Reciprocal Labs100
Omron Healthcare, Inc.71
Pari Innovative Manufacturers, Inc.80
Decided510(k)Device and applicantCode
Oct 16, 1998K983002MYSTIQUE ULTRASONIC NEBULIZER
Airsep Corp.
CAF
Sep 17, 1998K982179TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
Trudell Medical, CA
CAF
Sep 14, 1998K982408AEROTEE, MODEL # 1001
Piper Medical Products
CAF
Aug 24, 1998K981944BREATHERITE
Ventlab Corp.
CAF
Jun 18, 1998K981167STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
Dhd Healthcare Corp.
CAF
Jun 12, 1998K98007456 SERIES AEROSOL GENERATOR
Project Marketing
CAF
Jun 2, 1998K9808293ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
Steripak, Ltd.
CAF
May 27, 1998K980407HOPE NEBULIZER
B&B Medical Technologies, Inc.
CAF
Mar 19, 1998K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
Dhd Diemolding Healthcare Div.
CAF
Feb 18, 1998K974379ULTRANEB
Bremed Italia, S.R.L.
CAF
Feb 2, 1998K972657ULTRAMIST 2000
Texas Medical Industries, Inc.
CAF
Jan 21, 1998K9740560.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
Holopack International, LP
CAF
Dec 8, 1997K973468MODEL IRC 1199 SCOUT NEBULIZER
Invacare Corp.
CAF
Nov 13, 1997K970844ATOMISOR
Medical Consulting Service, Inc.
CAF
Oct 8, 1997K972778DEY VIAL SODIUM CHLORIDE 3%
Dey Laboratories, Inc.
CAF
Sep 26, 1997K971808SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
Monarch Medical
CAF
Aug 28, 1997K972467STERILE WATER FOR INHALATION, USP
Holopack International, LP
CAF
Aug 28, 1997K972466SODIUM CHLORIDE INHALATION SOLUTION, USP
Holopack International, LP
CAF
Aug 19, 1997K972371ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
Brasamerica Medical Equipment, Inc.
CAF
Aug 6, 1997K970344MDILOG, MODEL MDC-511
Medtrak Technologies, Inc.
CAF
Aug 1, 1997K971933PORT-NEB
Medic-Aid , Ltd.
CAF
Jul 31, 1997K972237HAND HELD MEDISPACER
Thayer Medical Corp.
CAF
Jun 24, 1997K970542MASTER NEB II
Bremed Italia, S.R.L.
CAF
Apr 16, 1997K963793OPTIVENT
Health Care Products, Inc.
CAF
Apr 15, 1997K970289COMPRESSOR/NEBULIZER #3650
Devilbiss Health Care, Inc.
CAF
Apr 1, 1997K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
Graham-Field, Inc.
CAF
Apr 1, 1997K970010FPT NEBULIZER
Fluid Propulsion Technologies, Inc.
CAF
Mar 19, 1997K952910THE SWIRLER NEBULIZER
Amici, Inc.
CAF
Feb 28, 1997K962534THERA-MIST NEBULIZER MODEL-P3000
Pegasus Research Corp.
CAF
Feb 25, 1997K963917HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
Holden Walker Corp.
CAF
Feb 25, 1997K962874RESPIFLO/S
Curtin & Associates International , Inc.
CAF
Feb 25, 1997K962872RESPIFLO
Tyco Healthcare Deutschaland GmbH, DE
CAF
Feb 21, 1997K964994CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
Contemporary Products, Inc.
CAF
Jan 13, 1997K962438MISTY OX TURBOHEATER
Vital Signs, Inc.
CAF
Jan 10, 1997K9640783050 SPORT-NEB
Medical Industries America, Inc.
CAF
Dec 23, 1996K960854SIEMENS SERVO ULTRA NEBULIZER 345
Pacesetter, Inc.
CAF
Dec 16, 1996K963910HEART NEBULIZER #100609
Vortran Medical Technology 1, Inc.
CAF
Dec 10, 1996K963924LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
Pari Holding Co.
CAF
Oct 22, 1996K962879SALTERLABS 8660 SERIES NEBULIZER
Salter Labs
CAF
Oct 17, 1996K962822OPTICHAMBER
Healthscan Products, Inc.
CAF
Aug 26, 1996K962085SALTER LABS 8990 SERIES NEBULIZER
Salter Labs
CAF
Aug 21, 1996K962072PRONEB TURBO COMPRESSOR MODEL 38V0200
Pari Holding Co.
CAF
Aug 15, 1996K962161BAXTER NEBULIZER CAP MODEL 2D0868
Baxter Healthcare Corp
CAF
Aug 15, 1996K961973DHD ACE WITH MASK KIT
Dhd Diemolding Healthcare Div.
CAF
Jul 16, 1996K961476SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
Salter Labs
CAF
Jun 11, 1996K955104HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
Automatic Liquid Packaging, Inc.
CAF
May 17, 1996K960675WALKHALER PORTABLE COMPRESSOR MODEL 45F70
Pari Holding Co.
CAF
Apr 26, 1996K960397MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
Healthline Medical
CAF
Mar 21, 1996K955805DUAL SPRAY MINISPACER
Thayer Medical Corp.
CAF
Feb 27, 1996K952326PULMOMIST
Global Medical Ent., Inc.
CAF

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