Zapalign LLC (repackager or relabeler, Fort Lauderdale, FL): 54 new FDA device listings, incl. mask, gas, anesthetic
Zapalign LLC (Fort Lauderdale, Florida): 54 new FDA device listings, incl. mask, gas, anesthetic. Its amount of 54 is top-decile (99th percentile of 2,570 records). Dated 50 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: 54 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 54.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 83 related FL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Zapalign LLC |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Fort Lauderdale, FL, US |
| New listings | 54 |
| Devices | Mask, Gas, Anesthetic; Unit, Operative Dental; Handpiece, Air-Powered, Dental; Anesthesia Conduction Kit; Needle, Conduction, Anesthetic (W/Wo Introducer); Resin, Denture, Relining, Repairing, Rebasing; Tube, Tracheostomy (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Strap, Head, Gas Mask; Agent, Tooth Bonding, Resin |
| Product codes | BSJ, EIA, EFB, CAZ, BSP, EBI, BTO, BTT, BTK, KLE, LZA, EGS, EBF, GFF, EBC |
| Device classes | Class I, Class II, Class III, Unclassified |
| Medical specialties | Anesthesiology, Dental, General Hospital, General, Plastic Surgery, Cardiovascular, Gastroenterology, Urology, Obstetrics/Gynecology |
| Brand names | MASK, GAS, ANESTHETIC; Unit, operative dental; Handpiece, air-powered, dental; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER); RESIN, DENTURE, RELINING, REPAIRING, REBASING; Tube, tracheostomy (w/wo connector); HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); STRAP, HEAD, GAS MASK |
| First new listing | 2026-05-02 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3043226252 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 54.0x median) |
| Peer records CSV (84 FL 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 (FL first): Oketz Logistics LLC (repackager or relabeler, Coral Gables, · Stellmacher Instruments Inc (repackager or relabeler, Orland · Surgipros LLC (repackager or relabeler, Palmetto, FL) · Structure Medical, LLC. (contract manufacturer, Naples, FL) · Gfa Production Inc (specification developer, Clearwater, FL) · 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: Zapalign LLC and 84 Florida peers
- Florida DeviceEstablishmentPulse records like this one: 84
- Zapalign LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $16,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Zapalign LLC in Fort Lauderdale, Florida?
Zapalign LLC (Fort Lauderdale, FL), a repackager or relabeler, added 54 FDA device listings between 2026-05-02 and 2026-09-16.
How does Zapalign LLC compare to other Florida DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 54 is 54.0x the median of 1 across 2,570 records. It is 50 days old; check the official source for later updates before acting.
Zapalign LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Zapalign LLC | Fort Lauderdale, FL | 54 | 99th | 2026-09-16 | This record |
| Oketz Logistics LLC | Coral Gables, FL | 56 | 99th | 2026-10-12 | Compare Zapalign LLC vs Oketz Logistics LLC → |
| Stellmacher Instruments Inc | Orlando, FL | 30 | 98th | 2026-09-24 | Compare Zapalign LLC vs Stellmacher Instruments Inc → |
| VIVE Health LLC | Naples, FL | 10 | 93rd | 2026-10-14 | View record → |
Related records
DeviceEstablishmentPulse: Repackager or relabeler DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Florida
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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.