Merz North America Inc

FDA Filings

This page includes the latest FDA filings for Merz North America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Merz North America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2135225
FEI Number3003407669
NameMerz North America, Inc.
Owner & OperatorMerz North America, Inc.
Contact Address6501 Six Forks Road
Raleigh NC 27615 US
Official Correspondent
  • Devon Allen
  • x-919-9857891-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4133 Courtney St., Suite 10
FRANKSVILLE, WI 53126 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number3013840437
FEI Number3013840437
NameMerz North America, Inc.
Owner & OperatorMerz North America, Inc.
Contact Address6501 Six Forks Road
Raleigh NC 27615 US
Official Correspondent
  • Devon Allen
  • x-919-9857891-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address13900 W. Grandview Parkway
Sturtevant, WI 53177 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler2020-10-15
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2020-10-15
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2020-10-15
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler2020-10-14
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2020-10-14
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2020-10-14
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-09-03
Merz North America, Inc.
Otc Medication2020-08-04
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler2020-07-30
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2020-07-30
Merz North America, Inc.
Otc Medication2020-07-29
Merz North America, Inc
Otc Medication2020-07-29
Merz North America, Inc
Otc Medication2020-07-29
Merz North America, Inc.
Otc Medication2020-07-29
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler2020-05-18
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2020-05-18
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2020-05-18
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant, RADIESSE Hands AND Radiesse (+) Lidocaine Demral Filler2020-04-15
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2020-04-15
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2020-04-15
MERZ NORTH AMERICA, INC
Radiesse(+) Lidocaine2020-03-17
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler2020-02-07
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2020-02-06
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler2020-02-04
MERZ NORTH AMERICA, INC
Radiesse Injecable Implant, Radiesse (+) Lidocaine Dermal Filler2019-12-26
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-12-26
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler2019-11-06
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-11-06
MERZ NORTH AMERICA, INC
Coaptite lnjectable lmplant2019-11-06
Merz North America, Inc.
Otc Medication2019-11-06
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2019-10-31
Merz North America, Inc.
CSH Cannula; STERiGLIDE2019-10-24
Merz North America, Inc.
Ulthera System2019-10-23
Merz North America, Inc.
Ulthera System2019-10-23
Merz North America, Inc, Chemische Fabrik Kreussler & Co. GmbH
Prescription Medication2019-09-12
MERZ NORTH AMERICA, INC
Belotero Balance (+) Lidocaine2019-08-29
MERZ NORTH AMERICA, INC
Belotero Balance2019-07-31
MERZ NORTH AMERICA, INC
Coaptite2019-06-26
Merz North America, Inc
Otc Medication2019-06-25
Merz North America, Inc.
Otc Medication2019-06-22
Merz North America, Inc
Otc Medication2019-06-22
Merz North America, Inc.
Otc Medication2019-06-20
MERZ NORTH AMERICA, INC
Belotero Balance2019-06-18
MERZ NORTH AMERICA, INC
Radiesse Injectable Implany and Radiesse (+) Lidocaine Dermal Filler2019-06-07
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Dermal Filler2019-06-07
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-06-07
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-06-07
MERZ NORTH AMERICA, INC
Coaptite Injectable Implant2019-06-07
MERZ NORTH AMERICA, INC
Coaptite Injectable Implant2019-06-07
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Dermal Filler (1.5cc and 0.8cc)2019-06-06
MERZ NORTH AMERICA, INC
Radiesse 1.5cc and 0.8cc2019-06-06
MERZ NORTH AMERICA, INC
Radiessse Hands, and Radiesse (+) Lidocaine Dermal Filler2019-05-17
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-05-17
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2019-05-17
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2019-05-03
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2018-10-23
MERZ NORTH AMERICA, INC
RADIESSE (+) Lidocaine 0.8cc and 1.5cc2018-08-12
MERZ NORTH AMERICA, INC
RADIESSE 0.8cc and 1.5cc2018-08-12
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2018-07-25
MERZ NORTH AMERICA, INC
Radiesse (+)2018-07-06
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Dermal Filter2018-07-06
MERZ NORTH AMERICA, INC
Radiesse2018-07-06
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2018-07-06
MERZ NORTH AMERICA, INC
Radiesse Hands, Radiesse (+) Lidocaine Dermal Filler2018-07-05
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2018-07-05
Merz North America, Inc
Prismplus Broad-Spectrum Sunscreen SPF 432018-06-01
Merz North America, Inc
Reactive Plus Anti-Oxidant Serum Plus Broad-spectrum SPF 452018-06-01
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2018-05-15
Merz North America, Inc.
Otc Medication2018-05-03
MERZ NORTH AMERICA, INC
RADIESSE (+) Lidocaine Dermal Filler 1.5CC2018-04-24
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant 1.5CC2018-04-24
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2018-04-03
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2018-04-02
MERZ NORTH AMERICA, INC.
DeScribe Transparent PFD Patch 2018-03-29
MERZ NORTH AMERICA, INC.
DeScribe Transparent PFD Patch 2018-03-29
MERZ NORTH AMERICA, INC.
DeScribe Transparent PFD Patch 2018-03-29
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2018-03-28
MERZ NORTH AMERICA, INC
Radiesse Hands, Radiesse (+) Lidocaine2018-03-28
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2018-03-28
MERZ NORTH AMERICA, INC
Coaptite Injectable Implant2018-03-28
MERZ NORTH AMERICA, INC
Radiesse Lidocaine Dermal Filler2018-02-12
MERZ NORTH AMERICA, INC
Radiessee Injectable Implant2018-02-12
MERZ NORTH AMERICA, INC
Coaptite2018-02-12
MERZ NORTH AMERICA, INC
RADIESSE Lidocaine Dermal Filler2018-01-02
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2018-01-02
MERZ NORTH AMERICA, INC
RADIESSE (+) Lidocaine Dermal Filler2017-11-30
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2017-11-30
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2017-11-30
Merz North America, Inc.
DESCRIBE PFD Patch2017-11-29
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Dermal Filler2017-11-21
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2017-11-21
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2017-09-18
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Injectable Implant2017-08-29
MERZ NORTH AMERICA, INC
RADIESSE (+) Lidocaine Derma Filler2017-06-27
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2017-06-27
MERZ NORTH AMERICA, INC
COAPTITE Injectabl Implant2017-06-27
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Injectable Implant2017-06-26
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2017-06-26
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT2017-06-13
MERZ NORTH AMERICA, INC
RADIESSE 1.5CC AND 0.3CC2017-06-13
MERZ NORTH AMERICA, INC
COAPTITE injectable implant2017-06-13
MERZ NORTH AMERICA, INC
Radiesse (+) Lidocaine Dermal Filler2017-05-05
MERZ NORTH AMERICA, INC
Radiesse Injectable Implant2017-05-05
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT (DERMAL FILLERS)2017-04-26
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT2017-04-26
MERZ NORTH AMERICA, INC
Belotero Balance Dermal Filler2017-04-14
MERZ NORTH AMERICA, INC
BELOTERO BALANCE2017-03-29
MERZ NORTH AMERICA, INC
RADIESSE (+) LIDOCAINE DERMAL FILLER2017-01-17
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT2017-01-17
MERZ NORTH AMERICA, INC
BELOTERO BALANCE DERMAL FILLER2017-01-04
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant; RADIESSE (+) Lidocaine Dermal Filler2016-10-26
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2016-10-26
MERZ NORTH AMERICA, INC
RADIESSE 0.8cc and 1.5cc2016-07-29
MERZ NORTH AMERICA, INC
RADIESSE 1.5cc2016-07-29
MERZ NORTH AMERICA, INC
RADIESSE 0.8cc2016-07-26
MERZ NORTH AMERICA, INC
RADIESSE 1.5CC2016-07-26
MERZ NORTH AMERICA, INC
RADIESSE (+) Lidocaine Dermal Filler2016-06-27
MERZ NORTH AMERICA, INC
RADIESSE Injectable Implant2016-06-27
MERZ NORTH AMERICA, INC
COAPTITE Injectable Implant2016-06-27
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT2016-06-23
MERZ NORTH AMERICA, INC
RADIESSE INJECTABLE IMPLANT2016-06-23
MERZ NORTH AMERICA, INC
RADIESSE, RADIESSE(+)2016-06-03
MERZ NORTH AMERICA, INC
RADIESSE, RADIESSE LOW VISCOSITY2016-06-03
MERZ NORTH AMERICA, INC
RADIESSE2016-06-03
Merz North America, Inc.
Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 302015-05-18
Merz North America, Inc.
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 302015-03-23
Merz North America, Inc.
Belotero Balance Dermal Filler2011-12-14
Merz North America, Inc.
Xeomin2011-08-01
Merz North America, Inc.
Xeomin2011-08-01
Merz North America, Inc.
Xeomin2011-08-01
Merz North America, Inc.
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 302011-04-01
Merz North America, Inc.
Cellfina System Prep Pack - CP12011-02-24
Merz North America, Inc.
Accessory Kit2010-11-02
Merz North America, Inc
Asclera2010-06-01
Merz North America, Inc
Asclera2010-06-01
Merz North America, Inc.
Radiesse Injectable Implant2007-12-17
Merz North America, Inc.
Radiesse Injectable Implant2007-12-17
Merz North America, Inc.
Prolaryn Gel Injectable Implant2007-12-17
Merz North America, Inc.
Prolaryn Gel Injectable Implant2007-12-17
Merz North America, Inc.
Radiesse? (+)2007-12-04
Merz North America, Inc.
Radiesse? (+)2007-12-04
Merz North America, Inc.
Radiesse Injectable Implant2007-12-04
Merz North America, Inc.
Radiesse Injectable Implant2007-12-04
Merz North America, Inc.
Radiesse? (+)2007-12-04
Merz North America, Inc.
Radiesse? (+)2007-12-04
Merz North America, Inc.
Radiesse Injectable Implant2007-12-04
Merz North America, Inc.
Radiesse Injectable Implant2007-12-04
Merz North America, Inc.
Coaptite Injectable Implant2007-12-04
Merz North America, Inc.
Coaptite Injectable Implant2007-12-04
Merz North America, Inc.
Prolaryn Plus Injectable Implant2007-12-04
Merz North America, Inc.
Prolaryn Plus Injectable Implant2007-12-04
Merz North America, Inc.
Rigid Injection Needle2003-08-05
Merz North America, Inc.
Rigid Injection Needle2003-08-05

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090219018Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER H.S.CODE 3923 301044 PCS
2020081362698Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER H.S.CODE 3923 301044 PCS
2020073055115Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER H.S.CODE 3923 301033 PCS
2020072851992Anvers,Belgium -> New York/Newark Area, Newark, New JerseyXEOMIN VIAL / MEDICAL EQUIPMENT586 CTN
2020072851992Anvers,Belgium -> New York/Newark Area, Newark, New JerseyXEOMIN VIAL / MEDICAL EQUIPMENT586 CTN
2020072357226Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER H.S.CODES 3923 3010 8424 897033 PCS
2020071746266Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER H.S.CODES 3923 3010 8424 897033 PCS
2020070159401Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyAIRLESS DIEPENSER H.S.CODE 39233010 8424897033 PCS
2020061941109Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 301061 PCS
2020061941109Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 301061 PCS
2020061941109Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 301061 PCS

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