H.S. Hospital Service S.p.A.
Rome Roma, IT
H.S. HOSPITAL SERVICE S.P.A. appears in FDA device records in Rome Roma, IT. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for H.S. Hospital Service S.p.A. between 2000 and 2024. The busiest year on record is 2000, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2002 | 3 |
| 2004 | 1 |
| 2009 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242029 | TRAP EASY | KNW | Substantially Equivalent | |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | GEI | Substantially Equivalent | |
| K182605 | HS AMICA devices family | GEI | Substantially Equivalent | |
| K150112 | HS AMICA DEVICES FAMILY | GEI | Substantially Equivalent | |
| K083157 | HS AMICA | NEY | Substantially Equivalent | |
| K033616 | TRAPMATIC SYSTEM SET | KNW | Substantially Equivalent | |
| K021525 | TOPCUT | FCG | Substantially Equivalent | |
| K020987 | BMN I TYPE MARROW ASPIRATION NEEDLE | KNW | Substantially Equivalent | |
| K013692 | TRAPSYSTEM SET | KNW | Substantially Equivalent | |
| K002947 | BIOMOL ASPIRATION BIOPSY NEEDLE | FCG | Substantially Equivalent | |
| K002946 | SILENT BIOPSY NEEDLE | FCG | Substantially Equivalent | |
| K002944 | PRECISA BIOPSY NEEDLE | FCG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010312 | 3008237808 | H.S. HOSPITAL SERVICE S.P.A. | Via Zosimo 13 - 00178 Rome - Italy, Rome Roma 00178 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain