5 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
FDA Enforcement
Class II
·Terminated·Merz North America, Inc.·December 9, 2015
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 facial wrinkles and folds.
FDA Enforcement
Class II
·Terminated·Merz North America, Inc.·August 31, 2016
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.
FDA Enforcement
Class II
·Terminated·Merz North America, Inc.·December 9, 2015
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 fold medialization and augmentation.
FDA Enforcement
Class II
·Terminated·Merz North America, Inc.·December 9, 2015
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 carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
FDA Enforcement
Class II
·Ongoing·Merz North America, Inc.·November 25, 2020