Kowa Pharmaceuticals America, Inc. (other, Montgomery, AL): 1 new FDA device listing, incl. ophthalmoscope, laser, scanning
Kowa Pharmaceuticals America, Inc. (Montgomery, Alabama): 1 new FDA device listing, incl. ophthalmoscope, laser, scanning. Its amount of 1 is above the median of 1 (50th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 50/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 10 related AL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Kowa Pharmaceuticals America, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Montgomery, AL, US |
| New listings | 1 |
| Devices | Ophthalmoscope, Laser, Scanning |
| Product codes | MYC |
| Device classes | Class II |
| Medical specialties | Ophthalmic |
| Brand names | FM-600 |
| First new listing | 2026-09-16 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 2080939 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (11 AL 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: 2026-09-16
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (AL first): Elite Medical, LLC (contract manufacturer, Florence, AL) · Curiteva, Inc. (contract manufacturer, Tanner, AL) · Turner Medical Inc. (contract manufacturer, Athens, AL) · Rohrer Aesthetics, Inc. (other, Homewood, AL) · Advanced Product Solutions Inc. (contract manufacturer, Doth · 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: Kowa Pharmaceuticals America, Inc. and 11 Alabama peers
- Alabama DeviceEstablishmentPulse records like this one: 11
- Kowa Pharmaceuticals America, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Alabama peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Kowa Pharmaceuticals America, Inc. in Montgomery, Alabama?
Kowa Pharmaceuticals America, Inc. (Montgomery, AL), a other, added 1 FDA device listing on 2026-09-16.
How does Kowa Pharmaceuticals America, Inc. compare to other Alabama DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 49 days old; check the official source for later updates before acting.
Kowa Pharmaceuticals America, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Kowa Pharmaceuticals America, Inc. | Montgomery, AL | 1 | 50th | 2026-09-16 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Euroimmun Us Inc. | Mountain Lakes, NJ | 3 | 77th | 2026-09-10 |
| Rohrer Aesthetics, Inc. | Homewood, AL | 3 | 77th | 2026-09-09 |
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DeviceEstablishmentPulse: Other DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Alabama
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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.