Lumitex, Inc.
United StatesFDA applicant, unverified
- Devices
- 131
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Lumitex, Inc. makes
Lumitex, Inc. manufactures surgical fibreoptic lighting solutions, including retractors with integrated illumination for spinal and orthopedic procedures, reusable and disposable light cables, and adaptors for compatibility with third-party systems. The company also produces open surgical site lights for direct illumination of internal tissues. Additionally, it supplies phototherapy blankets and pads designed for neonatal care.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) and UDI registries. Lumitex, Inc. is based in the United States.
Catalogue
Search and filter all 131 devicesShowing 1-50 of 131
Company details
- DUNS number
- 108631797
FDA recalls
FDA recall records list 2 recalls initiated by LUMITEX, INC., the earliest on 2009-07-01 and the most recent on 2019-12-11. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 11 Dec 2019 Z-0923-2020 Class II Terminated There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.
2009
- 1 Jul 2009 Z-1998-2009 Unclassified (pre-2012) Terminated Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.
Frequently asked questions
How many devices does LUMITEX, INC. have in the registry?
The registry currently lists 131 devices for LUMITEX, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LUMITEX, INC.'s devices?
Among its 50 most recently registered devices, LUMITEX, INC. has devices listed in EUDAMED (9 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do LUMITEX, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for LUMITEX, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for LUMITEX, INC.?
FDA recall records list 2 recalls initiated by LUMITEX, INC., the most recent initiated on 11 Dec 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from LUMITEX, INC. in the registry?
The most recently registered devices listed for LUMITEX, INC. include Lumitex Surgical Illuminator 013310, L&K Biomed BluEX Surgical Illuminator BR06-0001S, Medtronic Surgical Illuminator - Tube 013417 and Light Cable, Vaginal Retractor 03.012.140.