Microcuff GmbH
Weinheim, DE
Microcuff Gmbh appears in FDA device records in Weinheim, DE. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1265-06 | Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye * ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID Size: 5.5mm, Product Reference: I-HMICU- 55; ID Size: 6.0mm, Product Reference: I-HMICU- 60; ID Size: 6.5mm, Product Reference: I-HMICU- 65; ID Size: 7.0mm, Product Reference: I-HMICU- 70; ID Size: 7.5mm, Product Reference: I-HMICU-75; ID Size: 8.0mm, Product Reference: I-HMICU-80; ID Size: 8.5mm, Product Reference: I-HMICU-85; ID Size: 9.0mm, Product Reference: I-HMICU-90; and ID Size: 10.0mm Product Reference: I-HMICU-10 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany. | Inadequate seals and/or holes in the pouch may compromise the sterility of the product. | Terminated | ||
| Z-1264-06 | Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEOC-35; ID Size: 4,0mm, Product Reference: I-MPEOC-40; ID Size: 4.5mm, Product Reference: I-MPEOC-45; ID Size: 5,0mm, Product Reference: I-MPEOC-50; ID Size: 5,5mm, Product Reference: I-MPEOC-55; ID Size: 6,0mm, Product Reference: I-MPEOC-60; ID Size: 6,5mm, Product Reference: I-MPEOC-65 and ID Size: 7,0mm, Product Reference: I-MPEOC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany. | Inadequate seals and/or holes in the pouch may compromise the sterility of the product. | Terminated | ||
| Z-1263-06 | Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany. | Inadequate seals and/or holes in the pouch may compromise the sterility of the product. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain