FDA 510(k) Applications Submitted by SAN SON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K974506 |
12/01/1997 |
LSF HA COATED TRIAD TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
| K112936 |
10/03/2011 |
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM |
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA |
| K021021 |
03/29/2002 |
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K013826 |
11/19/2001 |
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) |
SIEMENS MEDICAL SYSTEMS, INC. |
| K014113 |
12/14/2001 |
ENDOMAP |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K021725 |
05/24/2002 |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS AG |
| K022831 |
08/26/2002 |
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS AG |
| K030281 |
01/27/2003 |
CRYOTRON 2 CRYOTHERAPY DEVICE |
CRYONIC MEDICAL NORTH AMERICA |
| K051775 |
07/01/2005 |
OSTEOMIMETIC SYNTHETIC BONE MATRIX |
BIOMIMETIC PHARMACEUTICALS INC. |
| K992968 |
09/03/1999 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K993729 |
11/04/1999 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K003699 |
12/01/2000 |
MEDIVISION IGS SYSTEM |
MEDIVISION (U.S.A.), INC. |
| K990296 |
01/28/1999 |
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) |
PRECISION BIOLOGIC |
| K990579 |
02/23/1999 |
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) |
PRECISION BIOLOGIC |
| K990580 |
02/23/1999 |
CRYOCHECK LA SURE, MODEL SUR25-10 |
PRECISION BIOLOGIC |
| K990814 |
03/11/1999 |
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 |
PRECISION BIOLOGIC |
| K981173 |
04/01/1998 |
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) |
PRECISION BIOLOGICALS, INC. |
| K981174 |
04/01/1998 |
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) |
PRECISION BIOLOGICALS, INC. |
| K982062 |
06/15/1998 |
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 |
PRECISION BIOLOGICALS, INC. |
| K010851 |
03/21/2001 |
HARRISON HAND HELD ADJUSTING INSTRUMENT |
HARRISON CBP SEMINARS |
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