Promedica Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Promedica Products, Inc. makes
Promedica Products, Inc. manufactures single-use surgical gloves, disposable respiratory masks (including flat and curved designs), and cardiovascular sutures for cardiac procedures. Their product line also includes a trans-mitral ventricular vent device for temporary heart support during surgery.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Their products are listed in the United States.
Catalogue
The Carpentier Trans-Mitral Ventricular Vent(Tm) Ref K883412
Regimes: 510(k) Registry: 510(k)C-Mask Ref K882882
Regimes: 510(k) Registry: 510(k)Peters Cardioflon(Tm) Suture Ref K913101
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Poly) Ref K892768
Regimes: 510(k) Registry: 510(k)Peters Cardionyl(Tm) Suture Ref K913102
Regimes: 510(k) Registry: 510(k)C-Mask(Flat) Ref K882883
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Promedica Products, Inc. have in the registry?
The registry currently lists 6 devices for Promedica Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promedica Products, Inc.'s devices?
Among its 6 most recently registered devices, Promedica Products, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Promedica Products, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Promedica Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Promedica Products, Inc. in the registry?
The most recently registered devices listed for Promedica Products, Inc. include THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM), C-MASK, PETERS CARDIOFLON(TM) SUTURE and PATIENT EXAMINATION GLOVES (POLY).