Advanced Med/Surg, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Advanced Med/Surg, Inc.” (first 1991, latest 1994), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 150 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | 4 | 4 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| IZG | System, X-Ray, Photofluorographic | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (9)
- Radiology (1)
Most recent Advanced Med/Surg, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942108 | COHORT BONE BRUSH | HWE | 1994-10-11 | 162 |
| K931538 | AMSET(TM) CANNULATED BONE SCREW | HWC | 1994-05-04 | 401 |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | LXH | 1992-06-03 | 58 |
| K921644 | AMSEN HOCKEY STICK CHISEL | LXH | 1992-06-03 | 58 |
| K921643 | AMSEN POSTERIOR DISC EVACUATOR | LXH | 1992-06-03 | 58 |
| K921642 | AMSEN DOUBLE-ENDED FORAMINAL PROBE | LXH | 1992-06-03 | 58 |
| K905023 | AMSET LOCKING PLATE SYSTEM | KWQ | 1992-01-31 | 450 |
| K911768 | AMSET(TM) BONE SCREW | HWC | 1991-10-04 | 168 |
| K905014 | AMSET PLD SYSTEM | HRX | 1991-04-01 | 146 |
| K903808 | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT | IZG | 1991-01-22 | 155 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Med/Surg, 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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Med/Surg, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Advanced Med/Surg, Inc.” (first 1991, latest 1994), across 6 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 Advanced Med/Surg, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Med/Surg, Inc. is 150 days.
Which FDA product codes appear under Advanced Med/Surg, Inc.?
The most frequent FDA product codes under this applicant name are LXH (Orthopedic Manual Surgical Instrument, 4); HWC (Screw, Fixation, Bone, 2); HRX (Arthroscope, 1).
Next steps
- See all 10 Advanced Med/Surg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXH, Advanced Med/Surg, 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.