Witt Biomedical Corp
United StatesFDA applicant, unverified
- Devices
- 11
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Witt Biomedical Corp makes
Witt Biomedical Corp manufactures patient monitoring systems, including central station and ECG management solutions like the Calysto Series IV Physi-Monitoring and Information System. Their portfolio also includes image and information management tools, such as the Calysto Image IV system, as well as integrated physiomonitoring and vascular care consoles like the XPER Information Management/PHYSIOMONITORING 5 System.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Search and filter all 11 devicesFDA recalls
FDA recall records list 1 recall initiated by Witt Biomedical Corp, initiated on 2005-09-16. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 16 Sep 2005 Z-0305-06 Unclassified (pre-2012) Terminated Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
Frequently asked questions
How many devices does Witt Biomedical Corp have in the registry?
The registry currently lists 11 devices for Witt Biomedical Corp. Devices recorded under merged duplicate company entries are counted once.
Which registries list Witt Biomedical Corp's devices?
Among its 11 most recently registered devices, Witt Biomedical Corp has devices listed in FDA 510(k) (11 devices).
What risk classes do Witt Biomedical Corp's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Witt Biomedical Corp's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Witt Biomedical Corp?
FDA recall records list 1 recall initiated by Witt Biomedical Corp, the most recent initiated on 16 Sep 2005. 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 Witt Biomedical Corp in the registry?
The most recently registered devices listed for Witt Biomedical Corp include CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM, WITT BIOMEDICAL SERIES II-EP, CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM and WITT BIOMEDICAL VX-80.