Smith & Nephew Medical Ltd (specification developer, HULL East Riding of Yorkshire, GB): 6 new FDA device listings, incl. dressing, wound, drug

Smith & Nephew Medical Ltd (HULL East Riding of Yorkshire): 6 new FDA device listings, incl. dressing, wound, drug. Its amount of 6 is above the median of 2 (88th percentile). Dated 29 days ago, it is in the active follow-up window. Score 85/100. As of 2026-11-04, 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: 6 · 88th percentile of 2,709 DeviceEstablishmentPulse records · 3.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 70 related GB DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSmith & Nephew Medical Ltd
Owner / operatorSmith And Nephew Medical Ltd.
RoleSpecification developer (outsources manufacturing)
Establishment typesForeign Private Label Distributor; Develop Specifications But Do Not Manufacture At This Facility
LocationHULL East Riding of Yorkshire, GB
New listings6
DevicesDressing, Wound, Drug; Negative Pressure Wound Therapy Powered Suction Pump
Product codesFRO, OMP
Device classesClass II, Unclassified
Medical specialtiesGeneral, Plastic Surgery
Brand namesDURAFIBER Ag Pro; RENASYS DYNAFLOW Kit; BIOSTEP; RENASYS EDGE Negative Pressure Wound Therapy System; PICO 14 Single Use Negative Pressure Wound Therapy; PICO 7 Single Use Negative Pressure Wound Therapy; PICO Fluid Management Pack
First new listing2026-09-30
Latest new listing2026-10-07
FDA registration number8043484
Registration expires2027-12-31
amount percentile88th of 2,709 (median 2, 3.0x 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: 2026-10-07
  • Data refreshed: 2026-11-04
  • 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, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Smith & Nephew Medical Ltd and 71 GB peers

  • GB DeviceEstablishmentPulse records like this one: 71
  • Smith & Nephew Medical Ltd's amount: 88th percentile of 2,709 records
  • Timing: Medium: dated in the last 30 days
  • Estimated pipeline if you contact every GB peer: $14,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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85 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • Listed in the last 45 days.

What is the DeviceEstablishmentPulse record for Smith & Nephew Medical Ltd in HULL East Riding of Yorkshire?

Smith & Nephew Medical Ltd (HULL East Riding of Yorkshire, GB), a specification developer (outsources manufacturing), added 6 FDA device listings between 2026-09-30 and 2026-10-07.

How does Smith & Nephew Medical Ltd compare to other DeviceEstablishmentPulse records?

Its amount of 6 sits in the upper half (88th percentile) of 2,709 records; the median is 2. It is 29 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.

Smith & Nephew Medical Ltd vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Smith & Nephew Medical LtdHULL East Riding of Yorkshire, GB688th2026-10-07
Synthes (USA) Products LLCWest Chester, PA790th2026-10-23
Deka Research & Development Corp.Manchester, NH586th2026-10-19
SHOULDER INNOVATIONS, IncGrand Rapids, MI790th2026-10-15

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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment

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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

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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