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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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169 supplements returned for P050052

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
radiesse injectable implant, radiesse hands, and radiesse (+) lidocaine dermal filler

supplement #: S128
Merz North America, Inc. Aug 27, 2021 change design/components/specifications/material  
radiesse (+) injectable implant

supplement #: S129
Merz North America, Inc. Sep 01, 2021 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
radiesse injectable implant and radiesse hands

supplement #: S130
Merz North America, Inc. Jun 08, 2021 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S131
Merz North America, Inc. Jun 25, 2021 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine implant

supplement #: S132
Merz North America, Inc. Oct 21, 2021 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant, including radiesse hands, radiesse (+) lidocaine, and radiesse (+) jawline

supplement #: S134
Merz North America, Inc. Feb 02, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, including radiesse® hands, radiesse® (+) lidocaine, and radiesse® (+) jawline

supplement #: S135
Merz North America, Inc. May 05, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S136
Merz North America, Inc. Sep 02, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S137
Merz North America, Inc. Jan 24, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S138
Merz North America, Inc. Jan 06, 2023 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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