Data / Medical devices / System, Suction, Lipoplasty
System, Suction, Lipoplasty (MUU): 23 FDA-registered makers in 6 countries
23 establishments in 6 countries are registered with the FDA to make System, Suction, Lipoplasty (product code MUU, Class 2, 21 CFR 878.5040). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on March 16, 2022, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MUU
- Device class
- 2
- Regulation
- 878.5040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 16 |
| Italy | 3 |
| Israel | 1 |
| France | 1 |
| Ireland | 1 |
| South Korea | 1 |
Makers of System, Suction, Lipoplasty
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lipogems International S.P.A. | Milan Milano, Italy | Specification developer | 3 | May 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Solta Medical, Inc. | Bothell, WA, United States | Remanufacturer, Repackager or relabeler, Specification developer | 3 | September 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx | Carlsbad, CA, United States | Manufacturer | 2 | March 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 2 | January 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 2 | December 4, 2009 | 0 | 2 | 0 | api.fda.gov |
| Alma Lasers Ltd. | CAESAREA Northern, Israel | Manufacturer | 1 | July 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| EmCyte Corporation | Fort Myers, FL, United States | Manufacturer | 1 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hydra SRL | Mirandola Modena, Italy | Specification developer | 1 | December 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Jointechlabs, Inc | Brandon, FL, United States | Manufacturer | 1 | November 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Syntr Health Technologies, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | July 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Thiebaud SAS | Paris Ile-de-France, France | Manufacturer | 1 | April 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| AbbVie Ireland NL B.V. Ballytivnan | Sligo, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Temecula, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| JG Plastics, Group LLC | Costa Mesa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDIKAN CO., Ltd. | Gangseo-gu Seoul, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Omnia SRL | Mirandola Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Arlington, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Metrix Company | Dubuque, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trident Manufacturing, Inc. | Pingree Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.