Medicon Co., Ltd.
Wonju-si Gangwon, KR
MEDICON CO., LTD. appears in FDA device records in Wonju-si Gangwon, KR. FDA records list 15 510(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 15 510(k) clearances for Medicon Co., Ltd. between 1981 and 2012. The busiest year on record is 1985, with 7. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 7 |
| 1986 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111341 | CLEANE / CLEANE POP | OZC | Substantially Equivalent | |
| K962087 | SERVOTRONIC EC100 SYSTEM | HWE | Substantially Equivalent | |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | JEY | Substantially Equivalent | |
| K850855 | TENS GB1001 DEVICE | GZJ | Substantially Equivalent | |
| K850852 | INFRARAX DEVICE | ILY | Substantially Equivalent | |
| K844702 | GAUZE ASORBABLE | EFQ | Substantially Equivalent | |
| K844573 | ABSORBABLE GAUZE PRODUCTS | EFQ | Substantially Equivalent | |
| K844574 | WHEELCHAIRS | IOR | Substantially Equivalent | |
| K844705 | SHOE COVERS | FXP | Substantially Equivalent | |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | FYF | Substantially Equivalent | |
| K844703 | GOWNS, SURGICAL | FYA | Substantially Equivalent | |
| K840034 | VACUUM STRETCHER IMMOBILIZER | FPP | Substantially Equivalent | |
| K823197 | MODEL 8300 TESTER | DRT | Substantially Equivalent | |
| K812873 | MEDICON #8200 AMS | BZQ | Substantially Equivalent | |
| K810153 | VENTILATORY EFFORT MONITOR | FLS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009862779 | 3009862779 | MEDICON CO., LTD. | 501, 504, 505, 506, 507ho, 200 Gieopdosi-ro, Jijeong-myeon, Wonju-si Gangwon 26354 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- EFQGauze/Sponge, Internal
- FYAGown, Surgical
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- ILYLamp, Infrared, Therapeutic Heating
- ISAMassager, Therapeutic, Electric
- FLSMonitor, Apnea, Facility Use
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- OZCOver The Counter Thermal Treatment For Acne.
- JEYPlate, Bone
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- FPPStretcher, Hand-Carried
- IORWheelchair, Mechanical
Recall records
No recall records for this company in the ingested FDA data.
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