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
M.D.L. S.r.l.
M.D.L. S.R.L.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004749705 | 3004749705 | M.D.L. S.R.L. | 1 | N | 2026-01-01 | Via Tavani 1/a Delebio (So) Sondrio IT 23014 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 175631 | 1870523105 | 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 | 2016-10-27 |
| 175631 | 1154082782 | ||||
| 175631 | 1330429281 | ||||
| 175631 | 1401309484 | ||||
| 175631 | 1655663523 | ||||
| 175631 | 1817535052 | ||||
| 175631 | 2043163580 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KNW | 1 | 2016-10-27 |
PMN#
GUDID#
Cell-HarvestOR - MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm
2025-04-29
Bone-HarvestOR - AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm
2025-04-29
MarkX - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
2025-02-28
MarkX - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
2025-02-28
Palium - REUSABLE AUTOMATIC BIOPSY INSTRUMENT
2021-05-17
Palium - AUTOMATIC REUSABLE GUNFOR SOFT TISSUES BIOPSY,PALIUM TYPE
2017-01-05
FastCutM - 10 CS- GUILLOTINE NEEDLE 14G X 130MMFOR SOFT TISSUE BIOPSY FOR PALIUMAND MAGNUM® BARD GUN, WITH COAXIAL
2017-02-21
FastCutM - GUILLOTINE NEEDLE 18G X 250MMFOR SOFT TISSUE BIOPSY FOR MAGNUMBARD TM AND PALIUM GUN,WITH COAXIAL
2017-02-21
PALIUM COAXIAL - GUILLOTINE NEEDLE 14Gx100mm FORSOFT TISSUE, PALIUM AND MAGNUMBARD TM WITH COAXIAL 13Gx75mm
2018-06-07
PALIUM COAXIAL - GUILLOTINE NEEDLE 12Gx 100 mmFOR SOFT TISSUE FOR PALIUM AND MAGNUM BARD TMWITH COXIAL 11G X 74MM
2018-06-07
AutoMark - 10 CS- SEMIAUTOM. NEEDLE 20G X 50mmNOT REPOSITIONABLE FOR MAMMARYNODULE LOCALIZATION, SINGLE HOOK
2017-01-05
AutoMark - CS 10-SEMIAUTOM, NOT REPOSITIONABLENEEDLE 20G X 50mm FOR MAMMARYNODULE LOCALIZATION, DOUBLE HOOK
2017-01-05
RepoMark - 5 CS - REPOSITIONABLE NEEDLE,HOMER TYPE 20G X 50mm FOR MAMMARYNODULES LOCALIZATION, SINGLE HOOK
2017-01-05
Mark - NOT REPOSITIONABLE NEEDLE20G X 70mm FOR MAMMARY NODULESLOCALIZATION WITH DOUBLE HOOK
2017-06-05
Mark - 10 CS - NOT REPOSITIONABLE NEEDLE20G X 100mm FOR MAMMARY NODULESLOCALIZATION WITH DOUBLE HOOK
2017-02-21
Mark - NOT REPOSITIONABLE NEEDLE20G X 120mm FOR MAMMARY NODULESLOCALIZATION WITH SINGLE HOOK
2017-03-23
AutoMark - SEMIAUTOM., NOT REPOSITIONABLENEEDLE 20G X 100mm FOR MAMMARYNODULE LOCALIZATION, DOUBLE HOOK
2017-06-05
RepoMark - 5 CS - REPOSITIONABLE NEEDLE, HOMERTYPE 20G X 70mm FOR MAMMARYNODULES LOCALIZATION, SINGLE HOOK
2017-01-05
RepoMark - REPOSITIONABLE NEEDLE, HOMERTYPE 20G X 100mm FOR MAMMARYNODULES LOCALIZATION, SINGLE HOOK,
2017-06-05
Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
2021-05-14
Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 120 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
2021-05-14
Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
2021-05-17
AutoMark - DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 50 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
AutoMark - DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
AutoMark - DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
MarkSlim - DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK
2021-05-17
Markslim - DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK
2021-05-17
RepoMark - DISPOSABLE REPOSITIONABLE NEEDLE 20G x 70 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
RepoMark - DISPOSABLE REPOSITIONABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
RepoMark - DISPOSABLE REPOSITIONABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
RepoMark - DISPOSABLE REPOSITIONABLE NEEDLE 20G x 50 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-05-17
PressTo - DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH INTERNAL TRAP SYSTEM, SAFETY, WIRE 11G x 150 mm
2021-04-26
Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
2021-04-26
Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
2021-04-26
MarkSlim - DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK
2021-04-26
MarkSlim - DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK
2021-04-26
AutoMark - DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-04-26
AutoMark - DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-04-26
RepoMark - DISPOSABLE REPOSITIONABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
2021-04-26
Themy - DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
2021-05-24