Data / Medical devices / Italy / M.D.L. S.R.L.
M.D.L. S.R.L.: FDA-registered device maker in Delebio (So) Sondrio, Italy, 1 510(k) clearance
M.D.L. S.R.L. is registered with the FDA (registration 3004749705) in Delebio (So) Sondrio, Italy. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004749705
- Address
- Via Tavani 1/a, Delebio (So) Sondrio, Italy, 23014
- Owner or operator
- M.D.L. S.r.l. (10047695)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 21, 2014
- Registered through
- 2026
- Brand names listed
- AUTOMARK Semiautomatic not repositionable needle XXGxYYYmm for mammary nodules localization, single hook, Bone-HarvestOR - Autologous bone harvesting system, CYTOCUT Disposable chiba needle XXGxYYYmm for aspirated cyto-histological biopsy, Cell-HarvestOR - Multiradial selective harvesting system of autologous bone marrow, EASYCUT Semiautomatic needle XXGxYYYmm for cytohistological biopsy by aspiration as for Menghini modified, EASYLOCK Modified Menghini needle, XXGxYYYmm for aspirated cytohistological biopsy, FAST-CUT E Disp. needle XXGxYYYmm for soft tissue biopsy compatible with automatic Promag 2.2. gun with coaxial XXGxYYmm, FAST-CUT E Disposable needle XXGYYYmm for soft tissue biopsy compatible with automatic Promag 2.2 gun and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Biopsy, Cardiovascular | DWO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2016 | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles | KNW | Substantially Equivalent | M.D.L. S.R.L. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 5, 2021 | 88430 | Class II | Terminated | Bone Marrow Transplantation biopsy needle | Sterility assurance may be compromised. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Biopsy Needle
- All makers of Instrument, Biopsy
- All makers of Needle, Biopsy, Cardiovascular
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Device, Percutaneous, Biopsy
Updated October 27, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.