510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Besmed Health Business Corporation

New Taipei City, TW

Besmed Health Business Corporation appears in FDA device records in New Taipei City, TW. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Besmed Health Business Corporation between 2003 and 2024. The busiest year on record is 2014, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Besmed Health Business Corporation, by decision year
YearClearances
20032
20091
20143
20152
20161
20181
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241339Besmed Bacterial Filter and HMEFCAHSubstantially Equivalent
K172804Besmed Peak Flow MeterBZHSubstantially Equivalent
K160112Besmed PEEP ValveBYESubstantially Equivalent
K150591Besmed Reusable Jet NebulizerCAFSubstantially Equivalent
K143150CO2 monitoring line with and without in-line filterCCKSubstantially Equivalent
K141355VOLUMETRIC INCENTIVE SPIROMETERBWFSubstantially Equivalent
K140370DISPOSABLE PRESSURE MANOMETERCAPSubstantially Equivalent
K133873TRIBALL INCENTIVE SPIROMETERBWFSubstantially Equivalent
K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially Equivalent
K031374BESMED VARIOUS MODELS OF TENS, BE-550/BE-660GZJSubstantially Equivalent
K031375BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580IPFSubstantially Equivalent

Registered establishments

FDA registered establishments for Besmed Health Business Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97105673003256355Besmed Health Business CorporationNo. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District, New Taipei City 24888 TW2026and 37 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-0109-2019Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask SterileClass IITerminated

Verification record

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