Polymedica Industries, Inc.
Golden, CO, US
Polymedica Industries, Inc. appears in FDA device records in Golden, CO. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Polymedica Industries, Inc. between 1993 and 1997. The busiest year on record is 1995, with 8. The most recent is 1997, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 8 |
| 1996 | 2 |
| 1997 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED | MGP | Substantially Equivalent | |
| K971045 | BASIS FLEXIBLE TIP DIGITAL THERMOMETER | FLL | Substantially Equivalent | |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | FRO | Substantially Equivalent | |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | MGP | Substantially Equivalent | |
| K962991 | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER | FLL | Substantially Equivalent | |
| K955383 | SPYROCOLLOID WOUND DRESSING | MGP | Substantially Equivalent for Some Indications | |
| K953885 | SPYROFLEX SKIN PROTECTOR | MGP | Substantially Equivalent | |
| K952756 | MEDI-AID BASAL THERMOMETER | LHD | Substantially Equivalent | |
| K952159 | BASIS DIGITAL THERMOMETER | FLL | Substantially Equivalent | |
| K953618 | SPYROFLEX WOUND DRESSING | MGP | Substantially Equivalent for Some Indications | |
| K951862 | A GEL WOUND DRESSING | MGQ | Substantially Equivalent | |
| K952217 | MITRAFLEX WOUND DRESSING WET-STICK | MGP | Substantially Equivalent | |
| K951730 | SPYROFOAM WOUND DRESSING | KMF | Substantially Equivalent | |
| K941673 | MEDIAID UNIVERSAL THERMOMETER | FLK | Substantially Equivalent | |
| K935783 | MITRAFLEX CAVITY WOUND DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K932676 | SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) | FRO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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