Flexmedics
Minneapolis, MN, US
Flexmedics appears in FDA device records in Minneapolis, MN. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Flexmedics between 1986 and 1999. The busiest year on record is 1988, with 6. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 6 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 2 |
| 1994 | 2 |
| 1995 | 2 |
| 1997 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | OCY | Substantially Equivalent | |
| K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING | OCY | Substantially Equivalent | |
| K952430 | FINESSE GUIDEWIRE CORONARY | DQX | Substantially Equivalent | |
| K943390 | FLEXFINDER GUIDEWIRE | DQX | Substantially Equivalent | |
| K942074 | FLEXFINDER GUIDEWIRE | KNY | Substantially Equivalent | |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | DZC | Substantially Equivalent | |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | HXB | Substantially Equivalent | |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | HRX | Substantially Equivalent | |
| K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | DQX | Substantially Equivalent | |
| K893626 | FLEXMEDICS GUIDEWIRE | DQX | Substantially Equivalent | |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | EJF | Substantially Equivalent | |
| K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | EJF | Substantially Equivalent | |
| K881331 | ORTHODONTIC NITINOL SPRINGS | EJW | Substantially Equivalent | |
| K881274 | CENTER BEND ARCH WIRES | EJF | Substantially Equivalent | |
| K881233 | STRAIGHT LENGTH ARCH WIRES | EJF | Substantially Equivalent | |
| K880882 | REVERSE CURVE ARCHWIRE | EJF | Substantially Equivalent | |
| K881163 | RECTANGULAR NITINOL ARCH WIRE | EJF | Substantially Equivalent | |
| K873649 | FLEX GOLD | EJF | Substantially Equivalent | |
| K870156 | FLEXMEDICS NITINOL MAMMORY WIRE | Substantially Equivalent | ||
| K863742 | FLEXMEDICS NITINOL ARCH WIRE | DZC | 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
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