Synemed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Synemed, Inc.” (first 1981, latest 1995), plus 1 PMA decision, across 7 product codes in 3 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
Plus 1 more product codes.
Review panels
Most recent Synemed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954037 | FIELD TREND | HPT | 1995-11-17 | 81 |
| K852936 | THE FIELDMASTER MODEL 275 | HPT | 1985-10-15 | 97 |
| K833274 | DERMATOLOGY HANDPIECE-OPHTH LASER | HQF | 1983-12-03 | 73 |
| K831085 | SYNEVAC VACUUM SOURCE UNIT | BTA | 1983-06-08 | 65 |
| K828585 | OPTHALAS PHOTOCOAGULATOR | — | 1983-01-03 | 41 |
| K822853 | MODEL 200 SQUID | HPT | 1982-10-18 | 21 |
| K813282 | SYNEVAC VACUUM CURETTAGE SYSTEMS | HHI | 1981-12-14 | 27 |
| K811270 | SCOPE MASTER | HIH | 1981-09-08 | 125 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830080 | PMA | PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER | 1987-02-17 |
Recalls
openFDA lists no recalls under a recalling firm named Synemed, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Synemed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Synemed, Inc.” (first 1981, latest 1995), plus 1 PMA decision, across 7 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 Synemed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synemed, Inc. is 69 days.
Which FDA product codes appear under Synemed, Inc.?
The most frequent FDA product codes under this applicant name are HPT (Perimeter, Automatic, Ac-Powered, 3); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); HHI (System, Abortion, Vacuum, 1).
Next steps
- See all 8 Synemed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPT, Synemed, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.