Merz North America, Inc.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• merz.com

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

• Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30

  Merz North America, Inc.

  OCTINOXATE and ZINC OXIDE

• Journee Firm Riche Broad Spectrum Sunscreen SPF 30

  Merz North America, Inc.

  TITANIUM DIOXIDE and ZINC OXIDE

• Xeomin

  Merz North America, Inc.

  incobotulinumtoxinA

• Xeomin

  Merz North America, Inc.

  incobotulinumtoxinA

• Xeomin

  Merz North America, Inc.

  incobotulinumtoxinA

PMN#

• DESCRIBE PFD Patch

  2017-11-29

  Merz North America, Inc.

GUDID#

• US Accessory Kit - One Needle, One female to female luer lock connector, and one, 3mL Syringe

  MERZ NORTH AMERICA, INC.

  2026-03-05

• US Rigid Needle with Support Cannula- Double Bevel - 9010M0

  MERZ NORTH AMERICA, INC.

  2026-03-05

• US Rigid Injection Needle with Huber Point - 9001M0

  MERZ NORTH AMERICA, INC.

  2026-03-05

• Prolaryn Gel - "Prolaryn Gel is a temporary, injectable, carboxymethylcellulose-based implant designed to treat vocal fold insufficiency (such as paralysis) by augmenting or ""bulking"" the vocal fold for improved voice production."

  MERZ NORTH AMERICA, INC.

  2026-02-24

• Prolaryn Plus - Prolaryn® Plus is a sterile, latex-free, injectable implant used to treat vocal fold insufficiency, paralysis, and atrophy by augmenting (bulking) damaged vocal folds to improve voice production. It consists of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel, providing long-term structural support, with effects lasting up to one year.

  MERZ NORTH AMERICA, INC.

  2026-02-24

• "Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)" - 9012M0

  MERZ NORTH AMERICA, INC.

  2024-10-21

• Coaptite - The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles

  MERZ NORTH AMERICA, INC.

  2024-10-15

• Belotero Balance - Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.

  MERZ NORTH AMERICA, INC.

  2014-09-17

• "K-Pack II Needle 27 GA x 0.75"" T.W. (0,4 x 20mm)" - 9022M1X20

  MERZ NORTH AMERICA, INC.

  2022-12-08

• Coaptite - The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles.

  MERZ NORTH AMERICA, INC.

  2014-09-17

• Prolaryn Plus Injectable Implant - Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle.

  MERZ NORTH AMERICA, INC.

  2015-10-28

• Radiesse (+) Lidocaine1.5cc Injectable Implant - "Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75"" needles."

  MERZ NORTH AMERICA, INC.

  2015-08-19

• Radiesse (+) Lidocaine - "Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75"" needles."

  MERZ NORTH AMERICA, INC.

  2016-09-09

• Radiesse (+) Lidocaine 0.8cc Injectable Implant - "Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75"" needles."

  MERZ NORTH AMERICA, INC.

  2015-08-19

• Radiesse Moderate Fill 0.8cc - Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.

  MERZ NORTH AMERICA, INC.

  2014-09-17

• Radiesse Volume Advantage 1.5cc - Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.

  MERZ NORTH AMERICA, INC.

  2016-03-30

• Radiesse Injectable Implant1.5cc - Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.

  MERZ NORTH AMERICA, INC.

  2016-06-24

• Radiesse Volume Advantage 1.5cc - Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.

  MERZ NORTH AMERICA, INC.

  2014-09-17

• Radiesse Volume Advantage - Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (2) injectable implants and (4) 27 gauge thin walled x 0.75 inch needles.

  MERZ NORTH AMERICA, INC.

  2016-09-09

• Prolaryn Gel Injectable Implant - Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.

  MERZ NORTH AMERICA, INC.

  2015-10-28

• DeScribe Transparent PFD Patch - Individually packaged DeScribe PFD Patch (each)Contains 5 DeScribe PFD Patches.

  MERZ NORTH AMERICA, INC.

  2017-02-06

• DeScribe Transparent PFD Patch - Individually packaged DeScribe PFD Patch (each)

  MERZ NORTH AMERICA, INC.

  2017-02-06

• DeScribe Transparent PFD Patch - Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches.

  MERZ NORTH AMERICA, INC.

  2017-04-13