Company ยท US
Medamicus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2004. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 2004 | K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| Apr 9, 2003 | K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| Aug 23, 2002 | K022689 | MODIFICATION TO MEDAMICUS AXIA RSN Medamicus, Inc. | DYB |
| Jun 6, 2002 | K021004 | VALVED PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| May 21, 2002 | K020563 | MEDAMICUS AXIA RSN Medamicus, Inc. | DYB |
| Jan 24, 2002 | K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 Medamicus, Inc. | GZB |
| Jul 9, 2001 | K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE Medamicus, Inc. | DYB |
| Apr 13, 2000 | K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX Medamicus, Inc. | DYB |
| Mar 1, 2000 | K994097 | MEDAMICUS EPIDURAL INTRODUCER Medamicus, Inc. | GZB |
| Jun 28, 1999 | K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET Medamicus, Inc. | DYB |
| Jul 25, 1997 | K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 Medamicus, Inc. | DYB |
| Jun 3, 1997 | K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET Medamicus, Inc. | FEN |
| Jan 18, 1996 | K953734 | LUMAX(MODIFICATION) Medamicus, Inc. | FEN |
| Jan 11, 1996 | K954093 | LUMAX (MODIFICATION) Medamicus, Inc. | FEN |
| Jun 27, 1995 | K951313 | MEDAMICUS PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Sep 14, 1994 | K944107 | VIP PLUS PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Nov 9, 1993 | K932323 | PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Jan 7, 1993 | K920580 | TRANSDUCER, PRESSURE, CATHETER TIP Medamicus, Inc. | DXO |
| Nov 18, 1992 | K924491 | INTRODUCER, PERCUTANEOUS -- MODIFICATION Medamicus, Inc. | DYB |
| Aug 3, 1989 | K893658 | PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2003 | MedAmicus,Inc Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part Number 10684-003 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011 Terminated |
DYB | K021044 |