Atlas FDA

MRD

13 FDA 510(k) clearances · Product code

87 daysmedian time to decision
212 days90th percentile
13clearances measured

FDA profile

Official device name
Mammary Sizer
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2021: 20 · 2022: 31 · 2023: 30 · 2024: 37 · 2025: 48 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271)Mentor Worldwide, LLC2025-01-13
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552)Mentor Worldwide, LLC2024-09-06
NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229)Allergan2021-06-02
Sientra OPUS Silicone Gel Breast Implant Sizer (K200706)Sientra, Inc.2020-11-16
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163)Motiva USA, LLC2019-02-05
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (K151055)Mentor Worldwide, LLC2015-05-20
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (K131853)Mentor Worldwide, LLC2013-07-17
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421)Mentor Corporation2006-10-10
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (K010709)Mentor Corp.2001-04-23
MAMMARY SIZER, MAMMARY PROTHESIS SIZER (K984106)Specialty Surgical Products, Inc.1999-02-12
MAMMARY SIZER (K982258)Specialty Surgical Products, Inc.1998-09-08
MAMMARY SIZER (K961356)General Surgical Innovations1996-09-23
CUI MAMMARY PROTHESIS SIZER (K831566)Cox-Uphuff Intl.1983-08-12

Track MRD automatically

Every clearance here is in the API, with alerts when new ones post.