Horizons Intl. Corp.
Heredia, CR
HORIZONS INTL. CORP. appears in FDA device records in Heredia, CR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Horizons Intl. Corp. between 2001 and 2008. The busiest year on record is 2002, with 5. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 4 |
| 2002 | 5 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | FDI | Substantially Equivalent | |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | FDI | Substantially Equivalent | |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | EOQ | Substantially Equivalent | |
| K021998 | HORIZONS CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | FDI | Substantially Equivalent | |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | FBK | Substantially Equivalent | |
| K002236 | HORIZONS PAPILLOTOME | KNS | Substantially Equivalent | |
| K002235 | HORIZONS ERCP CANNULA | FGE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004083736 | 3004083736 | HORIZONS INTL. CORP. | ZETA FREE ZONE PARK, HEREDIA -- CR | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- EOQBronchoscope (Flexible Or Rigid)
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- FGEStents, Drains And Dilators For The Biliary Ducts
- JAKSystem, X-Ray, Tomography, Computed
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain