510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Galemed Corp.

WU-JIA Yilan, TW

GALEMED CORP. appears in FDA device records in WU-JIA Yilan, TW. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Galemed Corp. between 2002 and 2014. The busiest year on record is 2014, with 2. The most recent is 2014, with 2.

Clearances by year, as a table
510(k) clearance decisions for Galemed Corp., by decision year
YearClearances
20021
20031
20071
20081
20131
20142
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERCAHSubstantially Equivalent
K133957DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEBYESubstantially Equivalent
K122627GIO DIGITAL PRESSURE GUAGESCAPSubstantially Equivalent
K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEBTMSubstantially Equivalent
K072755GALEMED CPAP MASKBZDSubstantially Equivalent
K022124GALEMED PEAK FLOW METER, MODELS 3751/3752BZHSubstantially Equivalent
K021742GALEMED NEB-EASY NEBULIZERCAFSubstantially Equivalent

Registered establishments

FDA registered establishments for Galemed Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80433163003319165GALEMED CORP.No.87, LI-GONG 2ND RD.,, WU-JIA Yilan 268 TW2026and 23 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0022-2020Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802Reports of pressure relief manifold venting gas below the standard pressure.Class ITerminated
Z-0021-2020Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559Reports of pressure relief manifold venting gas below the standard pressure.Class ITerminated
Z-0020-2020Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562Reports of pressure relief manifold venting gas below the standard pressure.Class ITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain