Medical Device Manufacturer · US , Weston , MA

Louisville Laboratories, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1989

Total

Cleared

Denied

Louisville Laboratories, Inc. has 12 FDA 510(k) cleared medical devices. Based in Weston, US.

Historical record: 12 cleared submissions from 1989 to 1998.

Browse the FDA 510(k) cleared devices submitted by Louisville Laboratories, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Louisville Laboratories, Inc.

12 devices

1-12 of 12

Cleared Mar 09, 1998

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET

K980123 · GCJ

General & Plastic Surgery · 54d

Cleared Aug 12, 1997

LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS

K971796 · EZL

Orthopedic · 89d

Cleared Jul 30, 1997

VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION

K971791 · MBI

Orthopedic · 76d

Cleared Jul 30, 1997

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION

K971802 · MBI

Orthopedic · 76d

Cleared Jul 22, 1997

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT

K971797 · HET

Obstetrics & Gynecology · 68d

Cleared Jul 22, 1997

LAPAROTOMY BLADDER NECK SUSPENSION KIT

K971801 · EZL

Gastroenterology & Urology · 68d

Cleared Apr 04, 1997

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY

K963076 · HET

Obstetrics & Gynecology · 240d

Cleared Jul 08, 1996

CONTROL SYRINGE

K960882 · FMF

General Hospital · 139d

Cleared Jul 01, 1996

LOUISVILLE LABS OXYGEN HEAD TENT

K955535 · CBF

Anesthesiology · 209d

Cleared Mar 31, 1995

UNIVERSAL URETHRAL CATHETER

K946282 · EZC

Gastroenterology & Urology · 94d

Cleared Nov 02, 1993

EXTERNAL STABILITY PAD

K932979 · GCJ

General & Plastic Surgery · 138d

Cleared Sep 18, 1989

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE

K894757 · BZT

Anesthesiology · 53d

Louisville Laboratories, Inc. - FDA 510(k) Cleared Devices

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