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Data / Medical devices / Taiwan / Galemed Corp.

Galemed Corp.: FDA-registered device maker in WU-JIA Yilan, Taiwan, 21 510(k) clearances

Galemed Corp. is registered with the FDA (registration 8043316) in WU-JIA Yilan, Taiwan. It lists 33 device types. The FDA files 21 510(k) clearances under its listings, the newest dated April 18, 2014. 1 recall event names it as the recalling firm (1 Class I). 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 Galemed Corp.
FDA registration number
8043316
FEI number
3003319165
Address
No.87, LI-GONG 2ND RD., WU-JIA Yilan, Taiwan, 268
Owner or operator
GaleMed Corporation (8043316)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer
First device listed
July 26, 2002
Registered through
2026
Brand names listed
1" Response Manual Resuscitator, Adult, 1" Response Pediatric Manual Resuscitator, Child large, 12.5 cmH O Pressure Relief Manifold, 12.5 cmH2O Pressure Relief Manifold, 1ST RESPONSE INFANT MANUAL RESUSCITATOR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, 2L NON-LATEX BREATHING BAG, 4.3mm Luer Cap Thread Type Color: Blue and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Contract manufacturer, Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Contract manufacturer, Manufactureraccessdata.fda.gov
Blower, Powder, EntKCL1Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Contract manufacturer, Manufactureraccessdata.fda.gov
Clip, NoseBXJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Contract manufacturer, Manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Contract sterilizer, Manufactureraccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Contract manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Contract manufacturer, Manufactureraccessdata.fda.gov
Exerciser, Non-MeasuringION1Manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufactureraccessdata.fda.gov
Gas, Collecting VesselKGK1Manufactureraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Contract manufactureraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Contract manufacturer, Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Contract manufacturer, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Manufactureraccessdata.fda.gov
Resuscitator, Manual, Non Self-InflatingNHK2Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Spacer, Direct Patient InterfaceNVO2Contract manufacturer, Manufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Manufactureraccessdata.fda.gov
Support, Breathing TubeJAY1Manufactureraccessdata.fda.gov
Tent, OxygenBYL1Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufacturer, Manufactureraccessdata.fda.gov
Valve, Non-RebreathingCBP2Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Contract manufacturer, Manufactureraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Manufactureraccessdata.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
April 18, 2014K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERCAHSubstantially EquivalentGalemed Corp.accessdata.fda.gov
August 22, 2013K122627GIO DIGITAL PRESSURE GUAGESCAPSubstantially EquivalentGalemed Corp.accessdata.fda.gov
January 13, 2012K112852BABI PLUS NEONATAL RESUSCITATION BAGBTMSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
October 7, 2011K110471BABI PLUS INFANT NASAL CANNULA SYSTEMBZDSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
August 1, 2011K110383BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20BZDSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
February 8, 2011K103316FLOWRESTBTTSubstantially EquivalentVapotherm, Inc.accessdata.fda.gov
November 18, 2010K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0CAPSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
May 13, 2010K093716BABI PLUS INFANT NASAL CANNULA SYSTEMBZDSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
November 23, 2009K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERNHKSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
November 20, 2009K091862NESSI SPACERNVOSubstantially EquivalentPharmacaribeaccessdata.fda.gov
May 20, 2009K090317BABI*PLUS BUBBLE PAP VALVEBYESubstantially EquivalentA Plus Medicalaccessdata.fda.gov
October 15, 2008K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEBTMSubstantially EquivalentGalemed Corp.accessdata.fda.gov
November 16, 2007K072755GALEMED CPAP MASKBZDSubstantially EquivalentGalemed Corp.accessdata.fda.gov
September 7, 2005K051279CALDYNE, INC. EXHALOMETER EX100, MODEL EX100BZKSubstantially EquivalentCaldyne, Inc.accessdata.fda.gov
April 3, 2003K022124GALEMED PEAK FLOW METER, MODELS 3751/3752BZHSubstantially EquivalentGalemed Corp.accessdata.fda.gov
February 11, 2003K0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORBTMSubstantially EquivalentPortex, Inc.accessdata.fda.gov
October 25, 2002K021742GALEMED NEB-EASY NEBULIZERCAFSubstantially EquivalentGalemed Corp.accessdata.fda.gov
February 27, 2002K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXBTMSubstantially EquivalentPortex, Inc.accessdata.fda.gov
January 18, 2000K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST REBTMSubstantially EquivalentSims Portex, Inc.accessdata.fda.gov
February 14, 1996K953230CPR SUPER POCKET PACKCBPSubstantially EquivalentFormosa-Cj Health Business Corp.accessdata.fda.gov
March 30, 1990K895589MANUAL RESUSCITATORBTMSubstantially EquivalentHudson Oxygen Therapy Sales Co.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
May 30, 201983318Class ITerminatedBabi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562Reports of pressure relief manifold venting gas below the standard pressure.accessdata.fda.gov

Compare with other makers

Updated December 20, 2019. 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.