Company ยท US
Louisville Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1998. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 |
| CBF | Chamber, Hyperbaric | 1 |
| EZC | Catheter, Coude | 1 |
| FMF | Syringe, Piston | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 1998 | K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET Louisville Laboratories, Inc. | GCJ |
| Aug 12, 1997 | K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS Louisville Laboratories, Inc. | EZL |
| Jul 30, 1997 | K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION Louisville Laboratories, Inc. | MBI |
| Jul 30, 1997 | K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION Louisville Laboratories, Inc. | MBI |
| Jul 22, 1997 | K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT Louisville Laboratories, Inc. | EZL |
| Jul 22, 1997 | K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT Louisville Laboratories, Inc. | HET |
| Apr 4, 1997 | K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY Louisville Laboratories, Inc. | HET |
| Jul 8, 1996 | K960882 | CONTROL SYRINGE Louisville Laboratories, Inc. | FMF |
| Jul 1, 1996 | K955535 | LOUISVILLE LABS OXYGEN HEAD TENT Louisville Laboratories, Inc. | CBF |
| Mar 31, 1995 | K946282 | UNIVERSAL URETHRAL CATHETER Louisville Laboratories, Inc. | EZC |
| Nov 2, 1993 | K932979 | EXTERNAL STABILITY PAD Louisville Laboratories, Inc. | GCJ |
| Sep 18, 1989 | K894757 | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE Louisville Laboratories, Inc. | BZT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||