Fournitures Hospitalieres Industrie: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Fournitures Hospitalieres Industrie” (first 2002, latest 2018), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 252 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 349 |
| 2013 | 1 | 358 |
| 2014 | 0 | — |
| 2015 | 4 | 132 |
| 2016 | 0 | — |
| 2017 | 4 | 255 |
| 2018 | 1 | 222 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fournitures Hospitalieres Industrie took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 8 | 8 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
Most recent Fournitures Hospitalieres Industrie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171789 | ARROW Reverse Porous Glenoid | PHX | 2018-01-23 | 222 |
| K163148 | BePOD® Foot Screws | HWC | 2017-09-14 | 309 |
| K163710 | BePOD® EZ Weil Screws | HWC | 2017-09-08 | 252 |
| K162068 | ARROW Anatomical Porous glenoid | MBF | 2017-04-10 | 258 |
| K170040 | BePOD Cannulated Arthrodesis Screws | HWC | 2017-04-04 | 89 |
| K150568 | ARROW Humeral stems size 6 and 16 | PHX | 2015-10-29 | 237 |
| K150471 | CalcaNail Orthopedic Arthrodesis Nail | HSB | 2015-05-22 | 88 |
| K150463 | CalcaNail Orthopedic Nail | HSB | 2015-05-22 | 88 |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | PHX | 2015-03-20 | 175 |
| K120740 | COLS® FIXATION SYSTEM | MBI | 2013-03-05 | 358 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fournitures Hospitalieres Industrie.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fournitures Hospitalieres (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fournitures Hospitalieres Industrie?
FDA lists 24 510(k) clearances under the applicant name “Fournitures Hospitalieres Industrie” (first 2002, latest 2018), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fournitures Hospitalieres Industrie?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fournitures Hospitalieres Industrie is 106 days. Since 2017: 252 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fournitures Hospitalieres Industrie?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 8); HSB (Rod, Fixation, Intramedullary And Accessories, 6); PHX (Shoulder Prosthesis, Reverse Configuration, 4).
Next steps
- See all 24 Fournitures Hospitalieres Industrie clearances with predicates and recalls
- Run predicate analysis for product code HWC, Fournitures Hospitalieres Industrie's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.