FDA.reportPublic FDA data

Merz North America, Inc.

Matched from indexed company URL: Merz North America

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21352253003407669Merz North America, Inc.1Y2026-01-014133 Courtney St., Suite 10 FRANKSVILLE WI US 53126
30138404373013840437Merz North America, Inc.1Y2026-01-0113900 W. Grandview Parkway Sturtevant WI US 53177

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M2138700M05Belotero 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.866-862-1211info@merz.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2093981103840874P250020Belotero Volume (+) LidocaineLMH2026-05-19
2093981404019363P090016BELOTERO BALANCELMH2011-11-14
195091323535535P050052RADIESSE INJECTABLE IMPLANTLMH2006-12-22
2093981323535535P050052RADIESSE INJECTABLE IMPLANTLMH2006-12-22
195091730053704P050037RADIESSE 1.3CC AND 0.3CCLMH2006-12-22
2093981730053704P050037RADIESSE 1.3CC AND 0.3CCLMH2006-12-22
2093981223433962P040047COAPTITELNM2005-11-10
195091223433962P040047COAPTITELNM2005-11-10
2093981887406603K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)OHV2025-05-13
2093981479527053K243035Ulthera® SystemOHV2025-02-24
2093981175871584K233996Ulthera System (UC-1 Control Unit PRIME)OHV2024-02-22
2093981575368513K180623Ulthera SystemOHV2018-05-04
195091600436347K172689DESCRIBE PFD PatchPKO2017-11-29
2093981600436347K172689DESCRIBE PFD PatchPKO2017-11-29
2093981111761652K161885The Cellfina SystemOUP2016-10-05
2093981523675688K150505Cellfina SystemOUP2015-07-29
2093981966289900K150212DeScribe Transparent PFD PatchPKO2015-04-20
2093981883245042K134032ULTHERA SYSTEMOHV2014-06-20
2093982023784269K132028ULTHERA SYSTEMOHV2013-12-11
2093981757110497K122528ULTHERA SYSTEMOHV2012-08-28
2093981634543186K121700ULTHERA SYSTEMOHV2012-10-02
195091858314127K060815JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANTMIX2006-04-18
2093981858314127K060815JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANTMIX2006-04-18
2093981867646244K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1KHJ2002-01-09
195091867646244K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1KHJ2002-01-09
2093981734812242DEN080006ULTHERA SYSTEM, MODEL 8850-0001OHV2009-09-11
2093981076468006
195091076468006
2093981319872013
195091319872013
2093981338654759
195091338654759
2093981530722905
2093981751845696
195091751845696
2093981895360481
195091895360481

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OHV92025-05-13
LMH52011-11-14
PKO32017-11-29
OUP22016-10-05
MIX22006-04-18
LNM22005-11-10
KHJ22002-01-09

NDC#

Xeomin

Merz North America, Inc.

incobotulinumtoxinA

Xeomin

Merz North America, Inc.

incobotulinumtoxinA

Xeomin

Merz North America, Inc.

incobotulinumtoxinA

PMA#

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...

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...

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

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...

200 records. Showing 1-40. Next

PMN#

GUDID#

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 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 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