Parexel Intl. Corp.
United StatesFDA applicant, unverified
- Devices
- 14
What Parexel Intl. Corp. makes
The company manufactures diagnostic imaging and monitoring devices, including computed radiography systems (e.g., Philips PCR and Type 633 CR film), electrocardiograph machines (e.g., ACTA Genos and Personal C3), thermal imaging tools (e.g., FTI 100), and specialized medical hardware like the EMODREN guide needle and vacuum-fired porcelain dental restorations. It also produces imaging plates (e.g., Fuji CR), firmware packages for medical devices (e.g., ACTA Metra/Gnos), and acrylic dental materials (e.g., Natura-Tone or Luxopal CL).
These products are regulated under FDA 510(k) clearance requirements, with devices classified as Class I or Class II. The company’s offerings are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Parexel Intl. Corp. have in the registry?
The registry currently lists 14 devices for Parexel Intl. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Parexel Intl. Corp.'s devices?
Among its 14 most recently registered devices, Parexel Intl. Corp. has devices listed in FDA 510(k) (14 devices).
What risk classes do Parexel Intl. Corp.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Parexel Intl. Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Parexel Intl. Corp. in the registry?
The most recently registered devices listed for Parexel Intl. Corp. include SMA 26 TRANSDUCER, ACTA GENOS ELECTROCARDIOGRAPH, FUJI CR IMAGING PLATE and PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH.