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Data / Medical devices / Taiwan / Besmed Health Business Corporation

Besmed Health Business Corporation: FDA-registered device maker in New Taipei City, Taiwan, 13 510(k) clearances

Besmed Health Business Corporation is registered with the FDA (registration 9710567) in New Taipei City, Taiwan. It lists 47 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 14, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Besmed Health Business Corporation
FDA registration number
9710567
FEI number
3003256355
Address
No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District, New Taipei City, Taiwan, 24888
Owner or operator
BESMED HEALTH BUSINESS CORP. (9047866)
Roles
Exporter to the US, Manufacturer
First device listed
September 26, 2001
Registered through
2026
Brand names listed
, OXYGEN, AEROSOL, AIR CUSHION MASK, ANESTHESIA BREATHING CIRCUIT, BE-096, BE-560, BESMED AIR CUSHION MASK, BESMED ANESTHESIA CIRCUIT and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the US, Manufactureraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the US, Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Exporter to the US, Manufactureraccessdata.fda.gov
Bag, IceKYR1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Exporter to the US, Manufactureraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the US, Manufactureraccessdata.fda.gov
Calibrator, Volume, GasBXW1Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the US, Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Manufactureraccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Exporter to the US, Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the US, Manufactureraccessdata.fda.gov
Clip, NoseBXJ1Exporter to the US, Manufactureraccessdata.fda.gov
Compressor, Air, PortableBTI2Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Exporter to the US, Manufactureraccessdata.fda.gov
Cup, MenstrualHHE2Manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Exporter to the US, Manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufactureraccessdata.fda.gov
Flowmeter, Calibration, GasBXY1Exporter to the US, Manufactureraccessdata.fda.gov
Gauge, Gas Pressure, Cylinder/PipelineBXH1Manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Exporter to the US, Manufactureraccessdata.fda.gov
Irrigator, Powered NasalKMA1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Exporter to the US, Manufactureraccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Exporter to the US, Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Manufactureraccessdata.fda.gov
Pack, Heat, MoistIMA1Exporter to the US, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the US, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the US, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Exporter to the US, Manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Manufactureraccessdata.fda.gov
Spirometer, Therapeutic (Incentive)BWF2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Exporter to the US, Manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the US, Manufactureraccessdata.fda.gov
Transducer, Gas FlowBXP1Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the US, Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 14, 2024K241339Besmed Bacterial Filter and HMEFCAHSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
January 11, 2018K172804Besmed Peak Flow MeterBZHSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
April 29, 2016K160112Besmed PEEP ValveBYESubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
June 30, 2015K150591Besmed Reusable Jet NebulizerCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
February 5, 2015K143150CO2 monitoring line with and without in-line filterCCKSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
September 3, 2014K141355VOLUMETRIC INCENTIVE SPIROMETERBWFSubstantially EquivalentBesmed Health Business Corporationaccessdata.fda.gov
June 19, 2014K140370DISPOSABLE PRESSURE MANOMETERCAPSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
April 4, 2014K133873TRIBALL INCENTIVE SPIROMETERBWFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
November 28, 2003K031374BESMED VARIOUS MODELS OF TENS, BE-550/BE-660GZJSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
November 20, 2003K031375BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580IPFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
October 11, 2002K021446OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIRBTMSubstantially EquivalentOemedic International, Inc.accessdata.fda.gov
July 30, 2002K021442OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIRBTMSubstantially EquivalentOemedic International, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 9, 201881009Class IITerminatedAmbu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterileaccessdata.fda.gov

Compare with other makers

Updated November 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.