International Biophysics Corp.
United StatesFDA applicant, unverified
- Devices
- 14
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What International Biophysics Corp. makes
International Biophysics Corp. manufactures medical devices including ventilator vent valves (e.g., Model 1400), respiratory ventilation regulators (e.g., Model 1350), cuvettes for optical measurements (e.g., CM02 sizes), and suction systems for cardiac procedures. Their portfolio also includes oxygen concentrators (e.g., Model OXY1000), centrifugal and sterile/non-sterile pumps (e.g., FloPump 57mL, 32mL), monitoring systems (e.g., AccuFlow), and laser peel systems for dermatological use.
The company’s devices are classified under Class II in the U.S. and are listed via FDA 510(k) clearance. Their products are regulated under U.S. medical device laws, and the company is based in the United States.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 6 recalls initiated by International Biophysics Corp., the earliest on 2005-04-22 and the most recent on 2015-08-07. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 7 Aug 2015 Z-2422-2015 Class II Terminated It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Full distribution text
- 7 Aug 2015 Z-2423-2015 Class II Terminated It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Full distribution text
- 7 Aug 2015 Z-2424-2015 Class II Terminated It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Full distribution text
- 7 Aug 2015 Z-2422-2015 Class II Terminated It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
2011
- 5 Oct 2011 Z-0273-2012 Unclassified (pre-2012) Terminated Potential for the sterility to be compromised.
2005
- 16 Aug 2005 Z-1222-06 Unclassified (pre-2012) Terminated Tyvek pouches containing device labeled as sterile have defective seals.
- 22 Apr 2005 Z-1223-06 Unclassified (pre-2012) Terminated Complaints received regarding the device's failure to zero out.
Frequently asked questions
How many devices does International Biophysics Corp. have in the registry?
The registry currently lists 14 devices for International Biophysics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Biophysics Corp.'s devices?
Among its 14 most recently registered devices, International Biophysics Corp. has devices listed in FDA 510(k) (14 devices).
What risk classes do International Biophysics Corp.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for International Biophysics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for International Biophysics Corp.?
FDA recall records list 6 recalls initiated by International Biophysics Corp., the most recent initiated on 2015-08-07. 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 International Biophysics Corp. in the registry?
The most recently registered devices listed for International Biophysics Corp. include IBC VENT VALVE, MODEL 1400, IBC VRV, MODEL 1350, CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 and IBC FLOGUARD, MODEL 6050.