Custom Medical Specialties, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 18
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Custom Medical Suspension Strap Ref K944988
510(k) 510(k)
FDA recalls
2016
- 20 Sep 2016 Z-1234-2017 Class II Open since 2016 Sterility of syringe product could not be assured.
2013
- 12 Jul 2013 Z-0974-2014 Class II Terminated No endotoxin (LAL) testing to proper level.
2011
- 30 Sep 2011 Z-2328-2012 Class II Terminated The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2329-2012 Class II Terminated The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2330-2012 Class II Terminated The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2331-2012 Class II Terminated The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2349-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2350-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2351-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2352-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Show all 18 recalls
2011
- 30 Sep 2011 Z-2353-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2354-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2355-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2356-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2357-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2358-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2359-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
- 30 Sep 2011 Z-2360-2012 Class I Terminated The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Frequently asked questions
How many devices does Custom Medical Specialties, Inc. have in the registry?
The registry currently lists 1 device for Custom Medical Specialties, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Custom Medical Specialties, Inc.'s devices?
Among its 1 most recently registered device, Custom Medical Specialties, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Custom Medical Specialties, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Custom Medical Specialties, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Custom Medical Specialties, Inc.?
FDA recall records list 18 recalls initiated by Custom Medical Specialties, Inc., the most recent initiated on 2016-09-20. 1 of them is recorded as ongoing. 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 Custom Medical Specialties, Inc. in the registry?
The most recently registered devices listed for Custom Medical Specialties, Inc. include CUSTOM MEDICAL SUSPENSION STRAP.