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

• AFTER CARE

  Merz North America

  DIMETHICONE

• 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

• Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45

  Merz North America, Inc

  Octinoxate and Zinc Oxide

PMA#

• RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline

  2023-01-12

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS142 Date Received12/15/2022 Decision Date01/12/2023 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• P040047 COAPTITE® Injectable Implant

  2023-01-12

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS069 Date Received12/15/2022 Decision Date01/12/2023 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplem...

• RADIESSE® Injectable Implant

  2023-01-12

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS121 Date Received12/15/2022 Decision Date01/12/2023 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• COAPTITE® Injectable Implant

  2022-12-15

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS068 Date Received12/09/2022 Decision Date12/15/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplem...

• RADIESSE® Injectable Implant

  2022-12-13

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS120 Date Received12/09/2022 Decision Date12/13/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler

  2022-11-30

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS140 Date Received11/01/2022 Decision Date11/30/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• COAPTITE Injectable Impant

  2022-11-30

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS067 Date Received11/01/2022 Decision Date11/30/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplem...

• RADIESSE® Injectable Implant

  2022-11-30

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS119 Date Received11/01/2022 Decision Date11/30/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• RADIESSE® Injectable Implant

  2022-11-22

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS118 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline

  2022-11-22

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS139 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• COAPTITE® Injectable Implant

  2022-11-22

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS066 Date Received11/01/2022 Decision Date11/22/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplem...

• Belotero Balance (+) Lidocaine

  2022-10-26

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS049 Date Received07/21/2022 Decision Date10/26/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track...

• RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline

  2022-09-02

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS136 Date Received04/12/2022 Decision Date09/02/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For...

• RADIESSE® Injectable Implant

  2022-09-02

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS115 Date Received04/12/2022 Decision Date09/02/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For...

• RADIESSE® Injectable Implant

  2022-05-05

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS114 Date Received04/08/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• RADIESSE® Injectable Implant, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline

  2022-05-05

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS135 Date Received04/08/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler

  2022-05-05

  MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS048 Date Received04/05/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

• RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline

  2022-02-02

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2022-02-02

  MERZ NORTH AMERICA, INC

• RADIESSE (+) Lidocaine Implant

  2021-10-21

  MERZ NORTH AMERICA, INC

• RADIESSE Implant

  2021-10-21

  MERZ NORTH AMERICA, INC

• Belotero Balance + Lidocaine

  2021-10-13

  MERZ NORTH AMERICA, INC

• RADIESSE (+) Lidocaine Dermal Filler

  2021-06-25

  MERZ NORTH AMERICA, INC

• Radiesse Injectable Implant

  2021-06-08

  MERZ NORTH AMERICA, INC

• Radiesse Injectable Implant and Radiesse Hands

  2021-06-08

  MERZ NORTH AMERICA, INC

• Belotero Balance

  2020-10-29

  MERZ NORTH AMERICA, INC

• COAPTITE Injectable Implant

  2020-10-23

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2020-10-23

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

  2020-10-23

  MERZ NORTH AMERICA, INC

• COAPTITE Injectable Implant

  2020-10-15

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2020-10-15

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

  2020-10-15

  MERZ NORTH AMERICA, INC

• COAPTITE Injectable Implant

  2020-10-14

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2020-10-14

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler

  2020-10-14

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2020-07-30

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

  2020-07-30

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

  2020-05-18

  MERZ NORTH AMERICA, INC

• RADIESSE Injectable Implant

  2020-05-18

  MERZ NORTH AMERICA, INC

• COAPTITE Injectable Implant

  2020-05-18

  MERZ NORTH AMERICA, INC

200 records. Showing 1-40. Next

PMN#

• DESCRIBE PFD Patch

  2017-11-29

  Merz North America, Inc.

GUDID#

• US Rigid Injection Needle with Huber Point - 9001M0

  MERZ NORTH AMERICA, INC.

  2026-03-05

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

  MERZ NORTH AMERICA, INC.

  2026-03-05

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

  MERZ NORTH AMERICA, INC.

  2026-03-05

• 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

• 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

• "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 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

• 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

• 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 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. 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 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 (+) 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 (+) 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 (+) 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

• 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

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

  MERZ NORTH AMERICA, INC.

  2017-04-13

• 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 5 DeScribe PFD Patches.

  MERZ NORTH AMERICA, INC.

  2017-02-06