Medelec Intl. Corp.
Miami Beach, FL, US
Medelec Intl. Corp. appears in FDA device records in Miami Beach, FL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Medelec Intl. Corp. between 1985 and 1996. The busiest year on record is 1985, with 6. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 6 |
| 1986 | 3 |
| 1987 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961013 | DISPOSABLE NEEDLE ELECTRODE | IKT | Substantially Equivalent | |
| K935017 | TD50 ELECTROMYOGRAPH | JXE | Substantially Equivalent | |
| K922548 | MEDELEC 2110 AND 2114 EEG | GWQ | Substantially Equivalent | |
| K920127 | ELECTROENCEPHALOGRAPH RECORDING SYSTEM | GWQ | Substantially Equivalent | |
| K912775 | SAPPHIRE 4ME EMG/EP SYSTEM | GWF | Substantially Equivalent | |
| K865106 | PROPHYLACTIC (CONDOM) MR. JOHNNY | HIS | Substantially Equivalent | |
| K863491 | BLOOD SPECIMEN COLLECTION DEVICES | JKA | Substantially Equivalent | |
| K854622 | PROPHYLACTIC (CONDOM) | HIS | Substantially Equivalent | |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | BRZ | Substantially Equivalent | |
| K854860 | BLADES, SCALPEL CARBON STEET | GES | Substantially Equivalent | |
| K854859 | BLADES, SCALPEL STAINLESS STEEL | GES | Substantially Equivalent | |
| K854858 | SCALPEL HANDLE | GDZ | Substantially Equivalent | |
| K854857 | SCALPEL, ONE-PIECE, DISPOSABLE | GDX | Substantially Equivalent | |
| K854563 | DISPOSABLE SYRINGES & NEEDLES | FMF | Substantially Equivalent | |
| K854561 | BLADE, SCALPEL | GES | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GESBlade, Scalpel
- HISCondom
- JXEDevice, Nerve Conduction Velocity Measurement
- IKTElectrode, Needle, Diagnostic Electromyograph
- GWQFull-Montage Standard Electroencephalograph
- GDZHandle, Scalpel
- GDXScalpel, One-Piece
- BRZSet, Blood Transfusion
- GWFStimulator, Electrical, Evoked Response
- FMFSyringe, Piston
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain