Medegen Medical Products
Gallaway, TN, US
Medegen Medical Products appears in FDA device records in Gallaway, TN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1043646 | 1043646 | Medegen Medical Products | 209 MEDEGEN DR., GALLAWAY, TN 38036 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- KXGApplicator, Absorbent Tipped, Sterile
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- FNYBasin, Emesis
- KTCBath, Sitz, Nonpowered
- KMEBedding, Disposable, Medical
- FOBBedpan
- OKGBody Fluid Clean Up Kit
- IPSCane
- FYFCap, Surgical
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KYWContainer, Liquid Medication, Graduated
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- NNIContainer, Specimen, Non-Sterile
- FMHContainer, Specimen, Sterile
- FXPCover, Shoe, Operating-Room
- IPRCrutch
- JSMCulture Media, Non-Propagating Transport
- LIODevice, Specimen Collection
- KIZDish, Tissue Culture
- KYXDispenser, Liquid Medication
- HEDDouche Apparatus, Vaginal, Therapeutic
- KKXDrape, Surgical, Antimicrobial
- FCEEnema Kit
- FMEGown, Examination
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- FMINeedle, Hypodermic, Single Lumen
- OEANon-Surgical Gown
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FOXStand, Infusion
- KYZSyringe, Irrigating (Non Dental)
- INPTips And Pads, Cane, Crutch And Walker
- FSMTray, Surgical, Instrument
- FNPUrinal
- ITJWalker, Mechanical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0860-03 | GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE | Finished products were not sterilized. | Terminated | ||
| Z-0859-03 | GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR | Finished products were not sterilized. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain