Company ยท US
Merz North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2017. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2020 | Merz North America, Inc. COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel ca Open, Classified |
LNM | None listed |
| Aug 19, 2016 | Merz North America, Inc. Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.
Product Usage:
RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe fa Terminated |
LMH | None listed |
| Dec 3, 2015 | Merz North America, Inc. PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency. Terminated |
KHJ | K013243 |
| Dec 3, 2015 | Merz North America, Inc. PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fo Terminated |
MIX | K060815 |
| Dec 3, 2015 | Merz North America, Inc. Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds. Terminated |
LMH | None listed |