Merz North America, Inc. (other, Sturtevant, WI): 4 new FDA device listings, incl. implant, dermal, for aesthetic use

Merz North America, Inc. (Sturtevant, Wisconsin): 4 new FDA device listings, incl. implant, dermal, for aesthetic use. Its amount of 4 is above the median of 1 (83rd percentile). Dated 43 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 22 related WI DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentMerz North America, Inc.
RoleOther
Establishment typesComplaint File Establishment per 21 CFR 820.198
LocationSturtevant, WI, US
New listings4
DevicesImplant, Dermal, For Aesthetic Use; System, Imaging, Pulsed Echo, Ultrasonic; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Product codesLMH, IYO, OHV
Device classesClass II, Class III
Medical specialtiesRadiology, General, Plastic Surgery
Brand namesBelotero Volume (+) Lidocaine; Belotero Intense (+) Lidocaine; Ulthera System
First new listing2026-05-27
Latest new listing2026-09-23
FDA registration number3013840437
Registration expires2027-12-31
amount percentile83th of 2,570 (median 1, 4.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-23
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Merz North America, Inc. and 23 Wisconsin peers

  • Wisconsin DeviceEstablishmentPulse records like this one: 23
  • Merz North America, Inc.'s amount: 83rd percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Wisconsin peer: $4,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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75 / 100 Score

  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • U.S. establishment.
  • Listed in the last 45 days.

What is the DeviceEstablishmentPulse record for Merz North America, Inc. in Sturtevant, Wisconsin?

Merz North America, Inc. (Sturtevant, WI), a other, added 4 FDA device listings between 2026-05-27 and 2026-09-23.

How does Merz North America, Inc. compare to other Wisconsin DeviceEstablishmentPulse records?

Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 43 days old, still within a typical 45-day follow-up window. Its Score of 75/100 puts it among the stronger signals in this feed.

Merz North America, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Merz North America, Inc.Sturtevant, WI483rd2026-09-23
Rapid Medical Inc.Southlake, TX483rd2026-09-20
Conmed CorporationUtica, NY377th2026-09-14
Euroimmun Us Inc.Mountain Lakes, NJ377th2026-09-10

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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