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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

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Device Name Company Date Approved Supplement Reason Other Information
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S169
Merz North America, Inc. Jun 16, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S170
Merz North America, Inc. Jun 26, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine

supplement #: S171
Merz North America, Inc. Jul 14, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S173
Merz North America, Inc. Dec 12, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, jawline indication

supplement #: S174
Merz North America, Inc. Jan 13, 2026 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant

supplement #: S175
Merz North America, Inc. Mar 18, 2026 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant

supplement #: S176
Merz North America, Inc. Mar 24, 2026 process change - manufacturer/sterilizer/packager/supplier  
p050052 radiesse® injectable implant; radiesse® hands; radiesse® (+) lidocaine; jawline indication

supplement #: S177
Merz North America, Inc. Mar 24, 2026 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands

supplement #: S178
Merz North America, Inc. May 14, 2026 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant

supplement #: S179
Merz North America, Inc. Jun 26, 2026 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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