Louisville Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Louisville Laboratories, Inc. makes
Louisville Laboratories, Inc. manufactures surgical instruments and kits for urological procedures, including bladder neck suspension systems with bone anchors, laparoscopic instrument trays, vaginal suturing kits, and a needle-point suture passer. The company also produces medical devices for respiratory support, such as an oxygen head tent, as well as diagnostic tools like a telemetric precordial stethoscope and urethral catheters.
The portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction and comply with U.S. medical device standards.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Louisville Laboratories, Inc. have in the registry?
The registry currently lists 12 devices for Louisville Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Louisville Laboratories, Inc.'s devices?
Among its 12 most recently registered devices, Louisville Laboratories, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Louisville Laboratories, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Louisville Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Louisville Laboratories, Inc. in the registry?
The most recently registered devices listed for Louisville Laboratories, Inc. include CONTROL SYRINGE, LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS, VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION and CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET.