Summit Medical Ltd. (foreign exporter, Gloucestershire, GB): 2 new FDA device listings, incl. instrument, surgical, orthopedic, pneumatic powered & accessory/attach
Summit Medical Ltd. (Gloucestershire): 2 new FDA device listings, incl. instrument, surgical, orthopedic, pneumatic powered & accessory/attach. Its amount of 2 is above the median of 1 (69th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 40/100. 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: 65 related GB DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Summit Medical Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Gloucestershire, GB |
| New listings | 2 |
| Devices | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Instrument, Surgical, Sonic And Accessory/Attachment |
| Product codes | HSZ, JDX |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Flexible microstructure chisel -single use- 160mm - 7mm; Foot pedal; Chisel microstructure set; Sterilisation tray handpiece; OrthoClast 2 Module 1 - Basic Set; Ceramic-inlay tappet; OrthoClast 2 base unit; SteriTray chisels set |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 9617155 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th 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: 2026-09-18
- 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: Summit Medical Ltd. and 66 GB peers
- GB DeviceEstablishmentPulse records like this one: 66
- Summit Medical Ltd.'s amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every GB peer: $13,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
40 / 100 Score
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Summit Medical Ltd. in Gloucestershire?
Summit Medical Ltd. (Gloucestershire, GB), a foreign exporter, added 2 FDA device listings between 2026-09-10 and 2026-09-18.
How does Summit Medical Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 48 days old; check the official source for later updates before acting.
Summit Medical Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Summit Medical Ltd. | Gloucestershire, GB | 2 | 69th | 2026-09-18 |
| Optikal (Southgate) Ltd | Borehamwood, GB | 3 | 77th | 2026-10-13 |
| Loudwater Trade Finance Ltd | LONDON England, GB | 3 | 77th | 2026-10-09 |
| Ad Supply Group Limited | London London, City of, GB | 39 | 99th | 2026-10-13 |
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DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
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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.