Where does the data come from?

openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Merit Medical Australia Pty Ltd. (foreign exporter, Braiside Victoria, AU): 6 new FDA device listings, incl. catheter, embolectomy

Q: How to monitor Merit Medical Australia Pty Ltd. and peer foreign exporter records

DeviceEstablishmentPulse lists new DeviceEstablishmentPulse records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) as they are published; a free weekly email digest and paid alerts follow records like this one.

Merit Medical Australia Pty Ltd. (Braiside Victoria): 6 new FDA device listings, incl. catheter, embolectomy. Its amount of 6 is above the median of 1 (88th percentile). Dated 77 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of 2026-10-28 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 6 · 88th percentile of 2,570 DeviceEstablishmentPulse records · 6.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 22 related AU DeviceEstablishmentPulse records and the 5-column CSV export.

Field	Value
Establishment	Merit Medical Australia Pty Ltd.
Owner / operator	Merit Medical Systems, Inc.
Role	Foreign exporter
Establishment types	Export Device to the United States But Perform No Other Operation on Device
Location	Braiside Victoria, AU
New listings	6
Devices	Catheter, Embolectomy; Endoscopic Access Overtube, Gastroenterology-Urology; Endoscopic Irrigation/Suction System; Unit, Cryosurgical, Accessories; Dilator, Vessel, For Percutaneous Catheterization
Product codes	DXE, FED, OCX, GEH, DRE
Device classes	Class II
Medical specialties	Cardiovascular, Gastroenterology, Urology, General, Plastic Surgery
Brand names	Needle's Eye Snare Retrieval Set; Sidecar External Working Channel (FG-1011); C2 Cryoballoon Endogrip; C2 Cryoballoon Ablation System; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.
First new listing	2026-05-08
Latest new listing	2026-08-20
FDA registration number	3033589330
Registration expires	2027-12-31
amount percentile	88th of 2,570 (median 1, 6.0x median)
Peer records CSV (23 AU records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

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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
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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: Merit Medical Australia Pty Ltd. and 23 AU peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

AU DeviceEstablishmentPulse records like this one: 23
Merit Medical Australia Pty Ltd.'s amount: 88th percentile of 2,570 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every AU peer: $4,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

55 / 100 Score

Class II or III devices: QMS and regulatory demands.
Several new listings at once.

What is the DeviceEstablishmentPulse record for Merit Medical Australia Pty Ltd. in Braiside Victoria?

Merit Medical Australia Pty Ltd. (Braiside Victoria, AU), a foreign exporter, added 6 FDA device listings between 2026-05-08 and 2026-08-20.

How does Merit Medical Australia Pty Ltd. compare to other DeviceEstablishmentPulse records?

Its amount of 6 sits in the upper half (88th percentile) of 2,570 records; the median is 1. It is 77 days old; check the official source for later updates before acting.

Merit Medical Australia Pty Ltd. vs. top 3 peers

Organization	Location	Amount	Percentile	Record date
Merit Medical Australia Pty Ltd.	Braiside Victoria, AU	6	88th	2026-08-20
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi	Cankaya Ankara, TR	9	92nd	2026-10-17
Optikal (Southgate) Ltd	Borehamwood, GB	3	77th	2026-10-13
Loudwater Trade Finance Ltd	LONDON England, GB	3	77th	2026-10-09

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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.