Merz North America, Inc.
Raleigh, NC, US
Merz North America, Inc. appears in FDA device records in Raleigh, NC. FDA records list 15 510(k) clearances between and , 463 PMA records and 4 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Merz North America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Merz Aesthetics, Inc.registration, recall
- Ulthera Incregistration, 510(k), enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Merz North America, Inc. between 2009 and 2026. The busiest year on record is 2012, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260618 | Ulthera® System | OHV | Substantially Equivalent | |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | OHV | Substantially Equivalent | |
| K243035 | Ulthera® System | OHV | Substantially Equivalent | |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | OHV | Substantially Equivalent | |
| K192185 | The Cellfina System | OUP | Substantially Equivalent | |
| K180623 | Ulthera System | OHV | Substantially Equivalent | |
| K172689 | DESCRIBE PFD Patch | PKO | Substantially Equivalent | |
| K161885 | The Cellfina System | OUP | Substantially Equivalent | |
| K153677 | The Cellfina System | OUP | Substantially Equivalent | |
| K150505 | Cellfina System | OUP | Substantially Equivalent | |
| K134032 | ULTHERA SYSTEM | OHV | Substantially Equivalent | |
| K132028 | ULTHERA SYSTEM | OHV | Substantially Equivalent | |
| K121700 | ULTHERA SYSTEM | OHV | Substantially Equivalent | |
| K122528 | ULTHERA SYSTEM | OHV | Substantially Equivalent | |
| DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3022121566 | 3022121566 | MERZ AESTHETICS GMBH | Eckenheimer Landstrasse 100, Frankfurt Am Main Hesse 60318 DE | 2026 | |
| 2135225 | 3003407669 | Merz North America, Inc. | 4133 Courtney St., Suite 10, FRANKSVILLE, WI 53126 US | 2026 | and 1 more, listed in full below |
| 3013840437 | 3013840437 | Merz North America, Inc. | 13900 W. Grandview Parkway, Sturtevant, WI 53177 US | 2026 | and 5 more, listed in full below |
| 1012187 | 1012187 | Ulthera Inc | 6501 Six Forks Rd, Raleigh, NC 27615 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LNMAgent, Bulking, Injectable For Gastro-Urology Use
- GEACannula, Surgical, General & Plastic Surgery
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- LMHImplant, Dermal, For Aesthetic Use
- PKYImplant, Dermal, For Aesthetic Use In The Hands
- LRCInstrument, Ent Manual Surgical
- KDDKit, Surgical Instrument, Disposable
- GAANeedle, Aspiration And Injection, Disposable
- FHRNeedle, Gastro-Urology
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite
- OJVSingle Use Instrument Tray
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- MIXSystem, Vocal Cord Medialization
- PKOTransparent Patch For Use In Treatment Of Tattoos
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0401-2021 | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch. | The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. | Class II | Open, Classified | |
| Z-0749-2017 | Cellfina Prep Pack, Part No. CP1 | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. | Class II | Terminated | |
| Z-2607-2016 | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds. | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. | Class II | Terminated | |
| Z-0368-2016 | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. | Class II | Terminated | |
| Z-0367-2016 | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. | Class II | Terminated | |
| Z-0366-2016 | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. | Class II | Terminated | |
| Z-0694-2012 | MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin. | Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety. | Terminated | ||
| Z-0145-2012 | MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia. | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n | Terminated | ||
| Z-2221-2011 | Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. | Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain