Richard Hamer Assoc., Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Richard Hamer Assoc., Inc. makes
Richard Hamer Assoc., Inc. manufactures transparent and contour wound dressings, including hydrogel-based options for wound care, such as the Comfeel Plus line and Dermaplex Hydrogel Dressings in various sizes. The company also produces pressure relief dressings and sterile dressings like Mesalt. Additionally, it supplies medical sheaths, including the Costello-Everett Laser Cystoscope Sheath for urological procedures.
The company’s products are regulated under FDA classifications, including Class I, Class II, and Unclassified (U) devices, with several listed via the 510(k) pathway. These devices are intended for use in the United States, where the manufacturer is based.
Catalogue
Comfeel Plus Transparent Dressing Ref K942283
Regimes: 510(k) Registry: 510(k)Comfeel Plus Contour Dressing Ref K951327
Regimes: 510(k) Registry: 510(k)Comfeel Plus Wound Dressing Ref K941263
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Costello-Everett Laser Cystoscope Sheath Ref K942573
Regimes: 510(k) Registry: 510(k)Comfeel Plus Pressure Relief Dressing Ref K951325
Regimes: 510(k) Registry: 510(k)Mesalt Sterile Dressing Ref K934839
Regimes: 510(k) Registry: 510(k)Mpm Hydrogel Dressing Ref K950934
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Richard Hamer Assoc., Inc. have in the registry?
The registry currently lists 8 devices for Richard Hamer Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Richard Hamer Assoc., Inc.'s devices?
Among its 8 most recently registered devices, Richard Hamer Assoc., Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Richard Hamer Assoc., Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Richard Hamer Assoc., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Richard Hamer Assoc., Inc. in the registry?
The most recently registered devices listed for Richard Hamer Assoc., Inc. include COMFEEL PLUS TRANSPARENT DRESSING, COMFEEL PLUS CONTOUR DRESSING, COMFEEL PLUS WOUND DRESSING and DERMAPLEX HYDROGEL WOUND DRESSING (2X2, 4X4, 4X8, 6X10).