Elcam Medical, Inc.
Hackensack, NJ, US
ELCAM MEDICAL, INC. appears in FDA device records in Hackensack, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
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
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2087368 | 3003649401 | ELCAM MEDICAL, INC. | 1 University Plz Ste 511, Hackensack, NJ 07601 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1869-2017 | Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. | The stopcock was found to have punctures. | Class II | Terminated | |
| Z-2749-2015 | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile | Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. | Class II | Terminated | |
| Z-2748-2015 | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20. | Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain