DeviceEstablishmentPulse / report
Hart Enterprises, Inc. (contract manufacturer, Sparta, MI): 1 new FDA device listing, incl. endoscopic injection needle, gastroenterology-urology
Hart Enterprises, Inc. (Sparta, Michigan): 1 new FDA device listing, incl. endoscopic injection needle, gastroenterology-urology. Its amount of 1 is above the median of 1 (50th percentile). Dated 68 days ago, it serves as a historical benchmark. Score 65/100. 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: 24 related MI DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Hart Enterprises, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Sparta, MI, US |
| New listings | 1 |
| Devices | Endoscopic Injection Needle, Gastroenterology-Urology |
| Product codes | FBK |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | Carbon Medical Technologies Endoscopic Injection Needle, Durasphere® Injection Needle, Injecsure Injection Needle |
| First new listing | 2026-08-28 |
| Latest new listing | 2026-08-28 |
| FDA registration number | 1828424 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (25 MI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Hart Enterprises, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Hart Enterprises + all 25 MI records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
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: 2026-08-28
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MI first): Biopro, Inc. (contract manufacturer, Port Huron, MI) · Packaging Compliance Medical, LLC (contract manufacturer, Ke · SunMed Group Holdings, LLC (specification developer, Grand R · Pioneer Surgical Technology, Inc. (contract manufacturer, Ma · SHOULDER INNOVATIONS, Inc (specification developer, Grand Ra · 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
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Hart Enterprises, Inc. and 25 Michigan peers
- Michigan DeviceEstablishmentPulse records like this one: 25
- Hart Enterprises, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Michigan peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Hart Enterprises, Inc. in Sparta, Michigan?
Hart Enterprises, Inc. (Sparta, MI), a contract manufacturer, added 1 FDA device listing on 2026-08-28.
How does Hart Enterprises, Inc. compare to other Michigan DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 68 days old; check the official source for later updates before acting.
Hart Enterprises, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hart Enterprises, Inc. | Sparta, MI | 1 | 50th | 2026-08-28 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
Related records
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Michigan
More Michigan public-record feeds
New Trucking Company Registrations in Michigan SEC 8-K Corporate Trigger Events in Michigan New Grants by Vendor Procurement Need in Michigan Newly CLIA-Certified Laboratories by State & Certificate in Michigan Group Practices & Clinics from the NPI Registry in Michigan EPA Brownfields Award Tracker in Michigan FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in Michigan Carrier Out-of-Service Alerts in Michigan
How to monitor Hart Enterprises, Inc. and peer contract manufacturer records
Get new DeviceEstablishmentPulse records like Hart Enterprises, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ 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.