Company ยท US
Labeltape Meditect, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1995. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRX | Electrode, Electrocardiograph | 10 |
| GXY | Electrode, Cutaneous | 9 |
| KHE | Reagent, Occult Blood | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 1995 | K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD Labeltape Meditect, Inc. | GEI |
| Jan 14, 1992 | K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL Labeltape Meditect, Inc. | GXY |
| Dec 18, 1991 | K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL Labeltape Meditect, Inc. | GZJ |
| Oct 4, 1991 | K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION Labeltape Meditect, Inc. | KHE |
| Sep 4, 1990 | K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH Labeltape Meditect, Inc. | DRX |
| Jul 19, 1990 | K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT Labeltape Meditect, Inc. | GXY |
| Mar 1, 1990 | K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. Labeltape Meditect, Inc. | GXY |
| Feb 12, 1990 | K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE Labeltape Meditect, Inc. | GXY |
| Jan 22, 1990 | K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP Labeltape Meditect, Inc. | GXY |
| Oct 26, 1989 | K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. Labeltape Meditect, Inc. | DRX |
| Oct 12, 1989 | K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER Labeltape Meditect, Inc. | DRX |
| Aug 11, 1989 | K894043 | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS Labeltape Meditect, Inc. | GXY |
| Aug 11, 1989 | K894042 | SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS Labeltape Meditect, Inc. | GXY |
| Apr 18, 1989 | K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST Labeltape Meditect, Inc. | KHE |
| Mar 4, 1988 | K880649 | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING Labeltape Meditect, Inc. | GXY |
| Jan 28, 1988 | K875041 | FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE Labeltape Meditect, Inc. | DRX |
| Jan 28, 1988 | K872866 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) Labeltape Meditect, Inc. | DRX |
| Dec 30, 1987 | K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) Labeltape Meditect, Inc. | DRX |
| Dec 7, 1987 | K874628 | RESUBMITTED STANDARD MICROPORE ECG ELECTRODE Labeltape Meditect, Inc. | DRX |
| Nov 4, 1987 | K872869 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) Labeltape Meditect, Inc. | DXH |
| Oct 16, 1987 | K872871 | NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) Labeltape Meditect, Inc. | DRX |
| Apr 22, 1987 | K871026 | DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS Labeltape Meditect, Inc. | GXY |
| Mar 13, 1987 | K865011 | PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER Labeltape Meditect, Inc. | DRX |
| Feb 19, 1987 | K865090 | PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE Labeltape Meditect, Inc. | |
| Nov 21, 1986 | K863366 | PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE Labeltape Meditect, Inc. | DRX |
| Aug 6, 1986 | K862756 | PREGELLED INFANT DISPOSABLE ECG ELECTRODE Labeltape Meditect, Inc. | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||