Mdt Corp., Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Mdt Corp., Inc.” (first 1979, latest 1996), across 17 product codes in 6 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 4 | 4 |
| FLE | Sterilizer, Steam | 2 | 2 |
| GDC | Table, Operating-Room, Electrical | 2 | 2 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
Plus 7 more product codes.
Review panels
- General Hospital (8)
- General and Plastic Surgery (6)
- Dental (4)
- Microbiology (2)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent Mdt Corp., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR | FRC | 1996-05-23 | 87 |
| K942485 | MDT UROLOGY TABLE | MMZ | 1994-08-26 | 93 |
| K942486 | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | FQO | 1994-08-10 | 77 |
| K924380 | MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE | MLR | 1994-02-16 | 534 |
| K926081 | DENTAL LIGHT | EAZ | 1994-01-26 | 421 |
| K924955 | MDT/HARVEY MC-8 AND MC-10 | FLE | 1993-10-15 | 380 |
| K932094 | BOVIE ULTRASONIC SURGICAL ASPIRATOR | LFL | 1993-07-21 | 82 |
| K931169 | MDT DENTAL CHAIR | KLC | 1993-05-20 | 73 |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | FLF | 1993-03-31 | 397 |
| K922212 | MDT CASTLE BIOSIGN TEST PACK | FRC | 1992-08-10 | 90 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mdt Corp., 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 Mdt Corp., Inc.?
FDA lists 22 510(k) clearances under the applicant name “Mdt Corp., Inc.” (first 1979, latest 1996), across 17 product codes in 6 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 Mdt Corp., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mdt Corp., Inc. is 68 days.
Which FDA product codes appear under Mdt Corp., Inc.?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 4); FLE (Sterilizer, Steam, 2); GDC (Table, Operating-Room, Electrical, 2).
Next steps
- See all 22 Mdt Corp., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRC, Mdt Corp., 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.