Congruence Medical Solutions, LLC (specification developer, Baltimore, MD): 2 new FDA device listings, incl. ophthalmic syringe

Congruence Medical Solutions, LLC (Baltimore, Maryland): 2 new FDA device listings, incl. ophthalmic syringe. Its amount of 2 is above the median of 1 (69th percentile). Dated 76 days ago, it serves as a historical benchmark. Score 70/100. 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 13 related MD DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentCongruence Medical Solutions, LLC
RoleSpecification developer (outsources manufacturing)
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility
LocationBaltimore, MD, US
New listings2
DevicesOphthalmic Syringe; Syringe, Piston
Product codesQLY, FMF
Device classesClass II
Medical specialtiesGeneral Hospital
Brand namesMicroliter Dosing Syringe
First new listing2026-08-20
Latest new listing2026-08-20
FDA registration number3014623935
Registration expires2026-12-31
amount percentile69th of 2,570 (median 1, 2.0x 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: 2026-08-20
  • 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: Congruence Medical Solutions, LLC and 14 Maryland peers

  • Maryland DeviceEstablishmentPulse records like this one: 14
  • Congruence Medical Solutions, LLC's amount: 69th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Maryland peer: $2,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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70 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Congruence Medical Solutions, LLC in Baltimore, Maryland?

Congruence Medical Solutions, LLC (Baltimore, MD), a specification developer (outsources manufacturing), added 2 FDA device listings on 2026-08-20.

How does Congruence Medical Solutions, LLC compare to other Maryland DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 76 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.

Congruence Medical Solutions, LLC vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Congruence Medical Solutions, LLCBaltimore, MD269th2026-08-20
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI377th2026-10-14
Ge Medical Systems, LLCWaukesha, WI377th2026-10-06
Align Technology, Inc.San Jose, CA377th2026-09-30

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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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