510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Venner Medical (Singapore) Pte Ltd

Singapore Central Singapore, SG

VENNER MEDICAL (SINGAPORE) PTE LTD appears in FDA device records in Singapore Central Singapore, SG. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Venner Medical (Singapore) Pte Ltd between 2010 and 2020. The busiest year on record is 2010, with 2. The most recent is 2020, with 2.

Clearances by year, as a table
510(k) clearance decisions for Venner Medical (Singapore) Pte Ltd, by decision year
YearClearances
20102
20111
20191
20202
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmBTOSubstantially Equivalent
K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mmBTRSubstantially Equivalent
K191602APA Oxy BladeCCWSubstantially Equivalent
K110631VENNER TRACHEAL SEAL MONITORBSKSubstantially Equivalent
K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEBTOSubstantially Equivalent
K093135VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBEBTRSubstantially Equivalent

Registered establishments

FDA registered establishments for Venner Medical (Singapore) Pte Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077406223007740622VENNER MEDICAL (SINGAPORE) PTE LTD35 Joo Koon Circle, Singapore Central Singapore 629110 SG2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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