Angiomed U.S., Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Angiomed U.S., Inc.” (first 1986, latest 1988), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 52 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | 5 | 5 |
| KOD | Catheter, Urological | 4 | 4 |
| FAD | Stent, Ureteral | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 | 1 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Angiomed U.S., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874771 | ANGIOMED INTRODUCING SETS | DWB | 1988-01-12 | 54 |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | DWO | 1987-12-02 | 23 |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | FAD | 1987-01-30 | 94 |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | KOB | 1986-10-24 | 51 |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | GDM | 1986-09-29 | 69 |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | GCD | 1986-09-23 | 15 |
| K854910 | ANGIOFLOW | DQO | 1986-07-17 | 220 |
| K854912 | ANGIOMED GUIED WIRES | DQX | 1986-04-16 | 128 |
| K854908 | UROFLEX | FAD | 1986-03-14 | 95 |
| K855143 | ANGIOMED EXCHANGE DRAINAGE CATHETER SETS | KOD | 1986-03-11 | 75 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Angiomed U.S., Inc..
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.
- Angiomed GmbH & Co. Medizintechnik KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Angiomed U.S., Inc.?
FDA lists 24 510(k) clearances under the applicant name “Angiomed U.S., Inc.” (first 1986, latest 1988), across 16 product codes in 3 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 Angiomed U.S., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angiomed U.S., Inc. is 52 days.
Which FDA product codes appear under Angiomed U.S., Inc.?
The most frequent FDA product codes under this applicant name are GBO (Catheter, Nephrostomy, General & Plastic Surgery, 5); KOD (Catheter, Urological, 4); FAD (Stent, Ureteral, 2).
Next steps
- See all 24 Angiomed U.S., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBO, Angiomed U.S., Inc.'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.