Ferguson Medical: FDA filings under this applicant name
FDA lists 57 510(k) clearances under the applicant name “Ferguson Medical” (first 1985, latest 2004), across 33 product codes in 11 review panels. Median 510(k) review time under this name: 131 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| FRN | Pump, Infusion | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| FOX | Stand, Infusion | 3 | 3 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| FCG | Biopsy Needle | 2 | 2 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
Plus 23 more product codes.
Review panels
- General Hospital (14)
- Orthopedic (10)
- General and Plastic Surgery (10)
- Anesthesiology (8)
- Gastroenterology and Urology (3)
- Physical Medicine (3)
- Cardiovascular (2)
- Radiology (2)
- Ear, Nose and Throat (1)
- Neurology (1)
- Clinical Toxicology (1)
Most recent Ferguson Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033153 | DICOM THEATER | LLZ | 2004-04-23 | 206 |
| K963794 | PUNCTURENEEDLE | KNW | 1998-03-19 | 545 |
| K962615 | TUMORLOCALIZER MRI | MIG | 1998-03-19 | 624 |
| K971813 | EMBLA | OLV | 1998-01-16 | 245 |
| K972219 | ORTHOPEDIC PLATE SYSTEM | HRS | 1997-11-20 | 161 |
| K972217 | ORTHOPEDIC SCREW SYSTEM | HWC | 1997-11-20 | 161 |
| K970819 | TARGOBEAM | JAK | 1997-07-14 | 131 |
| K970280 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES | HSB | 1997-05-22 | 119 |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | HRS | 1997-05-22 | 119 |
| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | HSB | 1997-05-22 | 119 |
47 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ferguson Medical.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ferguson Medical (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ferguson Medical?
FDA lists 57 510(k) clearances under the applicant name “Ferguson Medical” (first 1985, latest 2004), across 33 product codes in 11 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 Ferguson Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ferguson Medical is 131 days.
Which FDA product codes appear under Ferguson Medical?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); FRN (Pump, Infusion, 5); CAF (Nebulizer (Direct Patient Interface), 3).
Next steps
- See all 57 Ferguson Medical clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ferguson Medical'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.