California Medical Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cannulation Tourniquet Set, 2 Tube Or 5 Tube Ref K000830
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
2012
- 2 Nov 2012 Z-0649-2013 Class II Terminated California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Full distribution text
- 2 Nov 2012 Z-0650-2013 Class II Terminated California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Full distribution text
- 2 Nov 2012 Z-0649-2013 Class II Terminated California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
2008
- 24 Jan 2008 Z-1175-2008 Unclassified (pre-2012) Terminated Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Full distribution text
- 24 Jan 2008 Z-1176-2008 Unclassified (pre-2012) Terminated Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Full distribution text
- 24 Jan 2008 Z-1177-2008 Unclassified (pre-2012) Terminated Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Full distribution text
- 24 Jan 2008 Z-1175-2008 Unclassified (pre-2012) Terminated Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Frequently asked questions
How many devices does California Medical Laboratories, Inc. have in the registry?
The registry currently lists 3 devices for California Medical Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list California Medical Laboratories, Inc.'s devices?
Among its 3 most recently registered devices, California Medical Laboratories, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do California Medical Laboratories, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for California Medical Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for California Medical Laboratories, Inc.?
FDA recall records list 5 recalls initiated by California Medical Laboratories, Inc., the most recent initiated on 2 Nov 2012. 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 California Medical Laboratories, Inc. in the registry?
The most recently registered devices listed for California Medical Laboratories, Inc. include CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS, CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE and ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE.