FDA 510(k) Applications Submitted by AL WEISENBORN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080317 |
02/06/2008 |
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL |
SYNTHEON LLC |
| K020614 |
02/25/2002 |
IRRIGATING CANNULA |
CA GUARD, LTD. |
| K080776 |
03/19/2008 |
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 |
USOPHTHALMIC, LLC |
| K991064 |
03/31/1999 |
METACARPAL FIXATION SYSTEM |
MEDCANICA, INC. |
| K001366 |
03/31/2000 |
PROSTEC 125I BRANCHYTHERAPY SNAPSEED |
PROSTEC LLC. |
| K041081 |
04/26/2004 |
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES |
HAND INNOVATIONS, INC. |
| K991486 |
04/28/1999 |
ULTRA-CBX |
MEDCANICA, INC. |
| K041157 |
05/03/2004 |
MODIFICATION TO SMALL BONE FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
| K011373 |
05/04/2001 |
INSTRUMENT DAMPING PORT |
MEDCANICA, INC. |
| K991653 |
05/13/1999 |
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM |
RYMED TECHNOLOGIES, INC. |
| K081608 |
06/09/2008 |
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) |
TOBY ORTHOPAEDICS, LLC |
| K022140 |
07/02/2002 |
WHISPER WEAR BREAST PUMP |
WHISPER WEAR |
| K992477 |
07/26/1999 |
ROTOSNARE |
INSCOPE, LLC. |
| K042059 |
07/30/2004 |
SHOULDER FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
| K982673 |
07/31/1998 |
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM |
KEY WEST FRAGRANCE & COSMETIC |
| K963092 |
08/08/1996 |
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER |
ADAM SPENCER CORP. |
| K032532 |
08/15/2003 |
TARAS THREADED FIXATION PIN |
UNION SURGICAL LLC |
| K032705 |
09/02/2003 |
DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
| K002775 |
09/06/2000 |
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
| K093021 |
09/29/2009 |
ATLANTIS SLIT LAMP |
USOPTHALMIC, LLC |
| K993280 |
09/30/1999 |
PROSTEC 125I BRACHYTHERAPY SEEDS |
PROSTEC LLC. |
| K013424 |
10/15/2001 |
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND |
HAND INNOVATIONS, INC. |
| K042902 |
10/20/2004 |
HERBERT ULNAR HEAD PROSTHESIS SYSTEM |
STUCKENBROCK MEDIZINTECHNIK GMBH |
| K033406 |
10/24/2003 |
SMALL BONE FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
| K964331 |
10/30/1996 |
ASC HIGH PRESSURE BRAIDED TUBES |
ADAM SPENCER CORP. |
| K955111 |
11/08/1995 |
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER |
ADAM SPENCE CORP. |
| K063416 |
11/13/2006 |
LUXVISION SLIT LAMP |
U.S. OPHTHALMIC LLC |
| K994232 |
12/16/1999 |
PHALANGEAL FIXATION SYSTEM |
MEDCANICA, INC. |
| K053513 |
12/16/2005 |
T-PIN |
UNION SURGICAL LLC |
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