Merrimack Laboratories: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Merrimack Laboratories” (first 1980, latest 1985), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Merrimack Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833528 | CARBON DIOXIDE LASER ML 825 | HHR | 1985-02-19 | 515 |
| K833483 | ENDOSCOPIC COUPLER | EOQ | 1984-02-10 | 126 |
| K827963 | MODEL ML-850 | — | 1982-09-13 | 24 |
| K827506 | MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY | — | 1982-06-11 | 38 |
| K827442 | ML-810 CARBON DIOXIDE LASER SYSTEM | — | 1982-05-19 | 33 |
| K800227 | ML-800 CO2 | HHR | 1980-03-03 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Merrimack Laboratories.
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 Merrimack Laboratories?
FDA lists 6 510(k) clearances under the applicant name “Merrimack Laboratories” (first 1980, latest 1985), across 3 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 Merrimack Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merrimack Laboratories is 36 days.
Which FDA product codes appear under Merrimack Laboratories?
The most frequent FDA product codes under this applicant name are HHR (Laser, Surgical, Gynecologic, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 6 Merrimack Laboratories clearances with predicates and recalls
- Run predicate analysis for product code HHR, Merrimack Laboratories'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.