Guardian Medical USA, Inc (contract manufacturer, Swanton, OH): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
Guardian Medical USA, Inc (Swanton, Ohio): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar. Its amount of 4 is above the median of 1 (83rd percentile). Dated 134 days ago, it serves as a historical benchmark. Score 80/100. 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: 41 related OH DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Guardian Medical USA, Inc |
| Owner / operator | Guardian Medical USA, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Swanton, OH, US |
| New listings | 4 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Sacroiliac Joint Fixation; Appliance, Fixation, Spinal Interlaminal; Posterior Cervical Screw System |
| Product codes | MAX, OUR, KWP, NKG |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-06-24 |
| FDA registration number | 3016261131 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (42 OH 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: 2026-06-24
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (OH first): Sterigenics US, LLC (contract sterilizer, Lewis Center, OH) · Aps Materials, Inc. (contract manufacturer, Dayton, OH) · Health Care Logistics, Inc. (repackager or relabeler, Urbanc · Hammill Mfg. Co. (contract manufacturer, Maumee, OH) · Neoconcepts LLC (other, Lewis Center, OH) · Browse all by state and category →
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: Guardian Medical USA, Inc and 42 Ohio peers
- Ohio DeviceEstablishmentPulse records like this one: 42
- Guardian Medical USA, Inc's amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $8,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Guardian Medical USA, Inc in Swanton, Ohio?
Guardian Medical USA, Inc (Swanton, OH), a contract manufacturer, added 4 FDA device listings between 2026-05-29 and 2026-06-24.
How does Guardian Medical USA, Inc compare to other Ohio DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 134 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Guardian Medical USA, Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Guardian Medical USA, Inc | Swanton, OH | 4 | 83rd | 2026-06-24 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Swiss-American CDMO,LLC | Carrollton, TX | 4 | 83rd | 2026-10-12 |
Related records
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Ohio
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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.