FDA 510(k) Applications Submitted by Melanie Raska
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970262 |
01/23/1997 |
MULTI-CHANNEL COMPRESSION BTE (SD) |
MIRACLE-EAR, INC. |
| K150303 |
02/06/2015 |
XXL Vascular Balloon Dilatation Catheter |
BOSTON SCIENTIFIC CORP. |
| K960804 |
02/28/1996 |
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC |
MIRACLE-EAR, INC. |
| K000956 |
03/24/2000 |
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
BOSTON SCIENTIFIC SCIMED, INC. |
| K981788 |
05/20/1998 |
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER |
SCIMED LIFE SYSTEMS, INC. |
| K141521 |
06/09/2014 |
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
| K141597 |
06/13/2014 |
MUSTANG BALLOON DIALATION CATHETER |
Boston Scientific Corporation |
| K992123 |
06/23/1999 |
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC SCIMED, INC. |
| K972344 |
06/24/1997 |
MIRACLE-EAR DIGITAL BTE |
MIRACLE-EAR, INC. |
| K972345 |
06/24/1997 |
DAHLBERG/MIRACLE-EAR |
MIRACLE-EAR, INC. |
| K972346 |
06/24/1997 |
MIRACLE-EAR ITE DIGITAL |
MIRACLE-EAR, INC. |
| K992142 |
06/24/1999 |
SCIMED ANGIOGRAPHIC CATHETERS |
SCIMED |
| K954119 |
09/01/1995 |
MIRACLE EAR MIRAGE |
MIRACLE-EAR, INC. |
| K964419 |
10/01/1996 |
MIRACLE - EAR (ITE/ITC/CIC) |
MIRACLE-EAR, INC. |
| K964530 |
11/12/1996 |
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT |
MIRACLE-EAR, INC. |
| K964669 |
11/21/1996 |
MIRACLE-EAR OR AUDIOTONE |
MIRACLE-EAR, INC. |
| K964794 |
11/29/1996 |
DAHLBERG K-AMP BTE |
MIRACLE-EAR, INC. |
| K974559 |
12/05/1997 |
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS |
SCIMED LIFE SYSTEMS, INC. |
| K974684 |
12/16/1997 |
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER |
SCIMED LIFE SYSTEMS, INC. |
| K965049 |
12/18/1996 |
DAHLBERG (A-554) |
MIRACLE-EAR, INC. |
| K965057 |
12/18/1996 |
AUDIOTONE (A554H) |
MIRACLE-EAR, INC. |
| K965063 |
12/18/1996 |
AUDIOTONE (A-552) |
MIRACLE-EAR, INC. |
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