Company ยท US
Medelec Intl. Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1996. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GES | Blade, Scalpel | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 |
| HIS | Condom | 2 |
| BRZ | Set, Blood Transfusion | 1 |
| FMF | Syringe, Piston | 1 |
| GDX | Scalpel, One-Piece | 1 |
| GDZ | Handle, Scalpel | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 1996 | K961013 | DISPOSABLE NEEDLE ELECTRODE Medelec Intl. Corp., GB | IKT |
| Jul 28, 1994 | K935017 | TD50 ELECTROMYOGRAPH Medelec Intl. Corp., GB | JXE |
| Nov 3, 1992 | K922548 | MEDELEC 2110 AND 2114 EEG Medelec Intl. Corp., GB | GWQ |
| Jun 10, 1992 | K920127 | ELECTROENCEPHALOGRAPH RECORDING SYSTEM Medelec Intl. Corp., GB | GWQ |
| Nov 8, 1991 | K912775 | SAPPHIRE 4ME EMG/EP SYSTEM Medelec Intl. Corp., GB | GWF |
| May 20, 1987 | K865106 | PROPHYLACTIC (CONDOM) MR. JOHNNY Medelec Intl. Corp. | HIS |
| Oct 24, 1986 | K863491 | BLOOD SPECIMEN COLLECTION DEVICES Medelec Intl. Corp. | JKA |
| Apr 11, 1986 | K854622 | PROPHYLACTIC (CONDOM) Medelec Intl. Corp. | HIS |
| Jan 9, 1986 | K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I Medelec Intl. Corp. | BRZ |
| Dec 24, 1985 | K854860 | BLADES, SCALPEL CARBON STEET Medelec Intl. Corp. | GES |
| Dec 24, 1985 | K854859 | BLADES, SCALPEL STAINLESS STEEL Medelec Intl. Corp. | GES |
| Dec 24, 1985 | K854858 | SCALPEL HANDLE Medelec Intl. Corp. | GDZ |
| Dec 24, 1985 | K854857 | SCALPEL, ONE-PIECE, DISPOSABLE Medelec Intl. Corp. | GDX |
| Dec 9, 1985 | K854563 | DISPOSABLE SYRINGES & NEEDLES Medelec Intl. Corp. | FMF |
| Dec 2, 1985 | K854561 | BLADE, SCALPEL Medelec Intl. Corp. | GES |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||