# Zapalign LLC (repackager or relabeler, Fort Lauderdale, FL): 51 new FDA device listings, incl. cannula, manipulator/injector, uterine

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Zapalign LLC |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Fort Lauderdale, FL, US |
| New listings | 51 |
| Devices | Cannula, Manipulator/Injector, Uterine; Tube, Tracheal (W/Wo Connector); Cement, Dental; Humidifier, Respiratory Gas, (Direct Patient Interface); Suture, Absorbable, Synthetic, Polyglycolic Acid; Tubes, Gastrointestinal (And Accessories); Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Strap, Head, Gas Mask; Sealant, Pit And Fissure, And Conditioner |
| Product codes | LKF, BTR, EMA, BTT, GAM, KNT, BSP, BSR, BTK, EBC, EBF, LBH, MLN, MKJ, BTO |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Obstetrics/Gynecology, Anesthesiology, Dental, General, Plastic Surgery, Gastroenterology, Urology, Cardiovascular, General Hospital |
| Brand names | Cannula, manipulator/injector, uterine; Tube, tracheal (w/wo connector); CEMENT, DENTAL; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); Suture, absorbable, synthetic, polyglycolic acid; Tubes, gastrointestinal (and accessories); NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER); STYLET, TRACHEAL TUBE |
| First new listing | 2026-05-22 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3043226252 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
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.