16 results
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37ms
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Sources: EU EUDAMED, US FDA
BIOWY CORPORATION
FDA registration
BIOWY CORPORATION·3 products·🇺🇸 United States
Biowy PICC Catheter
FDA UDI
Biowy Corporation·00851739007057·
Biowy Tym Tube
FDA UDI
Biowy Corporation·00851739007064·
Biowy Freezing Bag
FDA UDI
Biowy Corporation·00851739007002·Biowy Freezing Bag FB50, Max Volume: 50 mL
Biowy PICC Catheter S Kit
FDA UDI
Biowy Corporation·00851739007156·PICC 4F Single Lumen Catheter S Kit
Biowy PICC Catheter
FDA UDI
Biowy Corporation·00851739007040·
Biowy Freezing Bag
FDA UDI
Biowy Corporation·00851739007033·Biowy Freezing Bag FB1000, Max Volume: 1000 mL
Biowy Freezing Bag
FDA UDI
Biowy Corporation·00851739007026·Biowy Freezing Bag FB500, Max Volume: 500 mL
Biowy PICC Catheter S Kit
FDA UDI
Biowy Corporation·00851739007163·PICC 5F Dual Lumen Catheter S Kit
Biowy Freezing Bag
FDA UDI
Biowy Corporation·00851739007019·Biowy Freezing Bag FB250, Max Volume: 250 mL
MESH, SURGICAL
FDA Adverse Event
Injury
·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023
PRECISION
FDA Adverse Event
Malfunction
·ADVANCED BIONIS CORPORATION·Product code LGW·September 8, 2006
Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.
FDA Recall
Terminated
·Steris Corporation·Product code MLR·July 3, 2012
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices