Merz North America

FDA Filings

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

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

MERZ PHARMA GMBH & CO. KGAA

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Mederma PM Merz North America	Otc Medication	2024-03-16
Mederma Advanced Merz North America	Otc Medication	2024-03-16
AFTER CARE Merz North America	Otc Medication	2023-09-29
AFTER CARE Merz North America	Otc Medication	2023-07-13
MICRO DAY RICHE Merz North America	Otc Medication	2022-10-01
AFTER CARE Merz North America	Otc Medication	2020-11-14
MICRO DAY RICHE Merz North America	Otc Medication	2020-11-14
MICRO DAY RICHE Merz North America	Otc Medication	2020-08-07
AFTER CARE Merz North America	Otc Medication	2020-07-29
AFTER CARE Merz North America	Otc Medication	2019-06-14
AFTER CARE Merz North America	Otc Medication	2019-04-10
NDC 46783-004 Merz North America	AFTER CARE	2019-04-01
NDC 46783-275 Merz North America	MICRO DAY RICHE	2019-01-31
MICRO DAY RICHE Merz North America	Otc Medication	2019-01-31

Similar & Related FDA Registered Companies

Merz North America, Inc
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
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 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018031429508	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PAPER AND PAPERBOARD LABELS ALL KINDS NOT P ON 22 PALLETS FOLDING BOXES	176 BOX