Plasmedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Plasmedics, Inc. makes
Plasmedics, Inc. manufactures medical devices for anesthesia, respiratory monitoring, and vascular access, including pressure measurement catheters for monitoring blood flow, disconnect alarms for anesthesia circuits, apnea alarms for adult, pediatric, and neonatal patients, pediatric anesthesia masks with pacifier attachments, central venous catheters, and sterile biopsy needles.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Wedge Pressure Catheter Ref K830604
Regimes: 510(k) Registry: 510(k)Anesthesia/Respiratory Disconnect - Ref K831650
Regimes: 510(k) Registry: 510(k)Apnea Alarm For Adult-Pediatric & Neon Ref K831601
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Central Venous Catheter Ref K823351
Regimes: 510(k) Registry: 510(k)Sterile Biopsy Needles Ref K853559
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Plasmedics, Inc. have in the registry?
The registry currently lists 6 devices for Plasmedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plasmedics, Inc.'s devices?
Among its 6 most recently registered devices, Plasmedics, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Plasmedics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Plasmedics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plasmedics, Inc. in the registry?
The most recently registered devices listed for Plasmedics, Inc. include WEDGE PRESSURE CATHETER, ANESTHESIA/RESPIRATORY DISCONNECT -, APNEA ALARM FOR ADULT-PEDIATRIC & NEON and PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY.