New Dimensions IN Medicine, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What New Dimensions IN Medicine, Inc. makes
New Dimensions in Medicine, Inc. manufactures medical devices including a respiration monitor (MR-10), an amalgam dispenser for dental use, and disposable electrosurgical products such as a monopolar TENS electrode, infant grounding pad, and ECG packpads. The company also produces wound care solutions, including a hydrogel wound dressing modification (Clearsite).
These devices are regulated under FDA 510(k) clearance requirements, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the US.
Catalogue
Respiration Monitor Type Mr-10 Ref K822077
Regimes: 510(k) Registry: 510(k)Amalgam Dispenser Ref K771749
Regimes: 510(k) Registry: 510(k)Monoblock Prostoperative Tens Electrode Ref K832145
Regimes: 510(k) Registry: 510(k)Infant Electrosurgical Grounding Pad Ref K780405
Regimes: 510(k) Registry: 510(k)Ndm Infant Ecg Packpad Ref K780631
Regimes: 510(k) Registry: 510(k)Clearsite Hydrogel Wound Dressing Modification Ref K920677
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New Dimensions IN Medicine, Inc. have in the registry?
The registry currently lists 6 devices for New Dimensions IN Medicine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Dimensions IN Medicine, Inc.'s devices?
Among its 6 most recently registered devices, New Dimensions IN Medicine, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do New Dimensions IN Medicine, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for New Dimensions IN Medicine, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from New Dimensions IN Medicine, Inc. in the registry?
The most recently registered devices listed for New Dimensions IN Medicine, Inc. include RESPIRATION MONITOR TYPE MR-10, AMALGAM DISPENSER, MONOBLOCK PROSTOPERATIVE TENS ELECTRODE and INFANT ELECTROSURGICAL GROUNDING PAD.