Paragon Medical Inc.
Smithfield, UT, US
Paragon Medical Inc. appears in FDA device records in Smithfield, UT. FDA records list 5 510(k) clearances between and , no PMA records and 3 registered establishments. 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 5 510(k) clearances for Paragon Medical Inc. between 2003 and 2019. The busiest year on record is 2019, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190667 | Sonopet iQ Sterilization Tray | KCT | Substantially Equivalent | |
| K183701 | Stryker ChestShield Sterilization Tray System | KCT | Substantially Equivalent | |
| K173615 | Stryker Universal Select Sterilization Tray System | KCT | Substantially Equivalent | |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray | KCT | Substantially Equivalent | |
| K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1834331 | 1000306340 | PARAGON MEDICAL, INC. | 8 Matchett Dr., PIERCETON, IN 46562 US | 2026 | and 104 more, listed in full below |
| 1000517406 | 1000517406 | Paragon Medical Inc. | 125 W 1000 S, Smithfield, UT 84335 US | 2026 | and 57 more, listed in full below |
| 1835831 | 3001814066 | Paragon Medical Inc. | 7350 E. 86TH ST., Castleton, IN 46256 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
- HSTApparatus, Traction, Non-Powered
- GEFApplier, Staple, Surgical,
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- GEACannula, Surgical, General & Plastic Surgery
- JDQCerclage, Fixation
- HXDClamp
- FZTCutter, Surgical
- GCCDilator, Catheter
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- HWRDriver, Prosthesis
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- HXLMallet
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- EZXMesh, Surgical, Metal
- HBCMotor, Drill, Electric
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- HAWNeurological Stereotaxic Instrument
- HWMOsteotome
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDCProsthesis, Elbow, Constrained, Cemented
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HTRRasp
- HTOReamer
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- HWDStarter, Bone Screw
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- HXCWrench
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