Minntech Corp.
United StatesFDA applicant, unverified
- Devices
- 33
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Minntech Corp. makes
Minntech Corp. manufactures medical devices for renal therapy, including membrane oxygenators like the William Harvey HF5000 and Biocor 200, as well as dialyzers such as the Primus Hollow Fiber Dialyzer and Renatron II Dialyzer Reprocessing System. Their portfolio also covers water filtration systems like Fiberflo Hollow Fiber Capsule Filters, sterilization solutions including Renalin Cold Sterilant, and monitoring tools such as the Minnilert Pressure Monitor and Hemocor Plus Hemoconcentrator. Additionally, they produce peracetic acid test indicators like the Endpoint 500 for disinfection validation and Renaguard Dialysate Filters for fluid purification.
The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory authorization status. Minntech Corp. is based in the United States.
Catalogue
Search and filter all 33 devicesFDA recalls
FDA recall records list 1 recall initiated by Minntech Corp., initiated on 2010-06-15. By recorded status: 1 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.
2010
- 15 Jun 2010 Z-2213-2010 Unclassified (pre-2012) Terminated The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte
Full distribution text
- 15 Jun 2010 Z-2213-2010 Unclassified (pre-2012) Terminated The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte
Frequently asked questions
How many devices does Minntech Corp. have in the registry?
The registry currently lists 33 devices for Minntech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Minntech Corp.'s devices?
Among its 33 most recently registered devices, Minntech Corp. has devices listed in FDA 510(k) (33 devices).
What risk classes do Minntech Corp.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Minntech Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Minntech Corp.?
FDA recall records list 1 recall initiated by Minntech Corp., the most recent initiated on 15 Jun 2010. 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 Minntech Corp. in the registry?
The most recently registered devices listed for Minntech Corp. include BIOCOR 200 HIGH PERFORMANCEOXYGENATOR, ENDPOINT 500 PERACETIC ACID TEST INDICATORS, MINNILERT(R) PRESSURE MONITOR and PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000.