FDA Device Intelligence
HomeMARINA MEDICAL INSTRUMENTS, INC. › Marina Medical

Marina Medical

MARINA MEDICAL INSTRUMENTS, INC. · Model 800-950 · UDI-DI 00840306835964

KYW
2
510(k) clearances
209
Adverse events
13
Recalls
215
Facilities

Description

Stainless Steel Stand for Reusable 2L Canister

Recalls

DateFirmReason
2025-10-14Becton Dickinson & CompanyBD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
2024-05-09Sol-Millennium Medical Inc.Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.