Prodimed Plastimed Division
Le Plessis Bouchard, FR
Prodimed Plastimed Division appears in FDA device records in Le Plessis Bouchard, FR. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 6
- 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-2492-2020 | Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19 | Lack of assurance of sterility | Class II | Terminated | |
| Z-2491-2020 | Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US | Lack of assurance of sterility | Class II | Terminated | |
| Z-2490-2020 | Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19 | Lack of assurance of sterility | Class II | Terminated | |
| Z-2489-2020 | Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US | Lack of assurance of sterility | Class II | Terminated | |
| Z-2488-2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US | Lack of assurance of sterility | Class II | Terminated | |
| Z-2487-2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US | Lack of assurance of sterility | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain