Porex Medical
Mchenry, IL, US
Porex Medical appears in FDA device records in Mchenry, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Porex Medical between 1983 and 1987. The busiest year on record is 1987, with 8. The most recent is 1987, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 4 |
| 1987 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | ETN | Substantially Equivalent | |
| K873044 | POREX OTOLOGY INSTRUMENTS | LRC | Substantially Equivalent | |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | KDG | Substantially Equivalent | |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | HQX | Substantially Equivalent | |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | HPZ | Substantially Equivalent | |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | Substantially Equivalent | ||
| K870182 | POREX(TM) MALAR IMPLANT | Substantially Equivalent | ||
| K870154 | POREX(TM) TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K863942 | POREX(TM) NOSE PROSTHESIS | FZE | Substantially Equivalent | |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | FWP | Substantially Equivalent | |
| K863939 | POREX(TM) EAR PROSTHESIS | FZD | Substantially Equivalent | |
| K860503 | THE POREX RETRACTOR TABLE | FSE | Substantially Equivalent | |
| K832283 | MEDPAR SURGICAL IMPLANTS | FWP | Substantially Equivalent | |
| K833586 | TLS BULB DRAINAGE SYSTEM | GCY | Substantially Equivalent | |
| K831372 | TLS SURGICAL MARKER | FZZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KDGChisel (Osteotome)
- HPZImplant, Eye Sphere
- HQXImplant, Orbital, Extra-Ocular
- LRCInstrument, Ent Manual Surgical
- FZZMarker, Skin
- FWPProsthesis, Chin, Internal
- FZDProsthesis, Ear, Internal
- FZEProsthesis, Nose, Internal
- ETNStimulator, Nerve
- FSETable, Operating-Room, Manual
- LCJTissue Expander And 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