Medical Dynamics, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Medical Dynamics, Inc.” (first 1988, latest 1998), across 16 product codes in 7 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GCB | Needle, Catheter | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FSW | Light, Surgical, Endoscopic | 1 | 1 |
| FWD | Camera, Television, Microsurgical, Without Audio | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| FWH | Camera, Cine, Surgical, Without Audio | 1 | 1 |
| GCP | Endoscope, Ac-Powered And Accessories | 1 | 1 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (9)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (2)
- Dental (1)
- General Hospital (1)
- Orthopedic (1)
- Physical Medicine (1)
Most recent Medical Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974542 | TRUE VISION, TRUE VISION II | EIA | 1998-02-17 | 76 |
| K921294 | VIDEO ENDOSCOPE-RIGID MODIFICATION | HET | 1994-07-20 | 855 |
| K934682 | SURGICAL VIDEO CAMERA AND ACCESSORIES | FWF | 1994-02-15 | 138 |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | GCB | 1993-07-22 | 177 |
| K915538 | OVER THE WIRE STONE BASKET | LQR | 1992-03-20 | 101 |
| K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION | KGX | 1992-03-04 | 181 |
| K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM | FGE | 1992-01-28 | 145 |
| K911296 | OPTICAL CATHETER ARTHROSCOPE | HRX | 1991-09-24 | 183 |
| K903339 | VIDEO ENDOSCOPE, RIGID | HET | 1991-03-06 | 224 |
| K904609 | XENON LIGHT SOURCE | HBI | 1990-12-18 | 68 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Dynamics, 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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Dynamics, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Medical Dynamics, Inc.” (first 1988, latest 1998), across 16 product codes in 7 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 Medical Dynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Dynamics, Inc. is 82 days.
Which FDA product codes appear under Medical Dynamics, Inc.?
The most frequent FDA product codes under this applicant name are GCB (Needle, Catheter, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); EIA (Unit, Operative Dental, 1).
Next steps
- See all 18 Medical Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCB, Medical Dynamics, 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.