Hager Worldwide, Inc.
Hickory, NC, US
HAGER WORLDWIDE, INC. appears in FDA device records in Hickory, NC. FDA records list 3 510(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 3 510(k) clearances for Hager Worldwide, Inc. between 2005 and 2006. The busiest year on record is 2005, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061933 | HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER | FMI | Substantially Equivalent | |
| K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | EJI | Substantially Equivalent | |
| K050658 | RESO-PAC PERIODONTAL DRESSING | EMA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1044031 | 1044031 | HAGER WORLDWIDE, INC. | 441 19th St SE, Hickory, NC 28602 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- EJRAgent, Polishing, Abrasive, Oral Cavity
- JTMAnaerobic Box Glove
- KXFApplicator, Absorbent Tipped, Non-Sterile
- EJLBur, Dental
- EIKCarver, Wax, Dental
- EMACement, Dental
- EFNCotton, Roll
- EHKCup, Prophylaxis
- LRJDisinfectant, Medical Devices
- EHJDisk, Abrasive
- EHZEvacuator, Oral Cavity
- JESFloss, Dental
- HTDForceps
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EGZHolder, Film, X-Ray
- EKFInstrument, Contouring, Matrix, Operative
- DZNInstruments, Dental Hand
- EAYLight, Fiber Optic, Dental
- EBHMaterial, Impression Tray, Resin
- DYNMouthpiece, Saliva Ejector
- FMINeedle, Hypodermic, Single Lumen
- EFHPaper, Articulation
- EBLPin, Retentive And Splinting, And Accessory Instruments
- QJCPlaque Disclosing Agent
- ELRPost, Root Canal
- EISRemover, Crown
- LCNScraper, Tongue
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- EJISyringe, Cartridge
- EFWToothbrush, Manual
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- NRDUnit, Operative Dental, Accessories
- ECBUnit, Syringe, Air And/Or Water
- EGDWax, Dental, Intraoral
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