Lifecore Biomedical

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012276274
• FEI Number: 3012276274
• Name: Lifecore Biomedical
• Owner & Operator: LIFECORE BIOMEDICAL, LLC
• Contact Address: 3515 LYMAN BLVD. --; Chaska MN 55318 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1245 Lakeview Dr ; Chaska, MN 55318 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
SUSTOL Heron Therapeutics, Inc., Wavelength Enterprises LTD, INKE, S.A., Lifecore Biomedical	Prescription Medication	2024-10-08
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2024-09-20
Syfovre Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Micro Measurement Laboratories, Inc., West Pharmaceutical Services, Inc., Packaging Coordinators, LLC, Lifecore Biome	Prescription Medication	2024-08-20
Syfovre Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Micro Measurement Laboratories, Inc., West Pharmaceutical Services, Inc., Packaging Coordinators, LLC, Lifecore Biome	Prescription Medication	2024-03-28
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2024-02-07
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2023-12-21
Syfovre Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Micro Measurement Laboratories, Inc., West Pharmaceutical Services, Inc., Packaging Coordinators, LLC, Lifecore Biome	Prescription Medication	2023-12-12
SUSTOL Heron Therapeutics, Inc., Wavelength Enterprises LTD, INKE, S.A., Lifecore Biomedical	Prescription Medication	2023-06-07
Syfovre Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Micro Measurement Laboratories, Inc., West Pharmaceutical Services, Inc., Packaging Coordinators, LLC, Lifecore Biome	Prescription Medication	2023-04-18
Syfovre Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Micro Measurement Laboratories, Inc., West Pharmaceutical Services, Inc., Packaging Coordinators, LLC, Lifecore Biome	Prescription Medication	2023-03-02
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2022-12-24
SUSTOL Heron Therapeutics, Inc., Wavelength Enterprises LTD, INKE, S.A., Lifecore Biomedical	Prescription Medication	2022-09-01
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2021-12-14
ZYNRELEF Heron Therapeutics, Inc., Lifecore Biomedical, Apitoria Pharma, Ltd., Cambrex Karlskoga AB, Pharma Packaging Solutions	Prescription Medication	2021-07-01
PMN P010029 | MOZ Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Euflexxa	2018-01-10
SUSTOL Heron Therapeutics, Inc., Wavelength Enterprises LTD, INKE, S.A., Lifecore Biomedical	Prescription Medication	2017-12-28
PMN P890047 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Duovisc	2017-11-03
PMN P840064 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Viscoat	2017-11-03
PMN P110007 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Healon Endocoat	2012-07-03
PMN P860047 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Ocucoat	2012-05-31
PMN P810025 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Amvisc	2012-05-31
PMN P810025 | LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Amvisc Plus	2012-05-31
LZP Lifecore Biomedical [LIFECORE BIOMEDICAL, LLC]	Lurocoat	2007-11-08
PMN K042730 LIFECORE BIOMEDICAL	CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G	2005-02-14

Similar & Related FDA Registered Companies

• LIFECORE BIOMEDICAL, INC.
• Lifecore Biomedical LLC
• Heron Therapeutics, Inc.
• Wavelength Enterprises LTD
• INKE, S.A.
• Apitoria Pharma, Ltd.
• Cambrex Karlskoga AB
• Pharma Packaging Solutions
• Apellis Pharmaceuticals, Inc.
• Juzen Chemical Corporation
• Bachem AG
• Eurofins Lancaster Laboratories, Inc.
• Eurofins Advantar Laboratories, Inc.
• Micro Measurement Laboratories, Inc.
• West Pharmaceutical Services, Inc.
• Packaging Coordinators, LLC
• Lifecore Biome

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019062963433	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	EQUIPMENT PLATFORM HS 8479.90	3 PCS