FDA 510(k) Applications Submitted by JOHN LIN
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K101118 |
04/21/2010 |
ACTIVON TULLE |
CALIDAD SOLUTIONS, INC. |
K011901 |
06/18/2001 |
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 |
SURVIVALINK CORP. |
K022210 |
07/08/2002 |
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 |
CARDIAC SCIENCE, INC. |
K042117 |
08/05/2004 |
PROXIS SYSTEM, MODEL EPS 101 |
VELOCIMED INC. |
K022929 |
09/04/2002 |
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 |
CARDIAC SCIENCE, INC. |
K072748 |
09/27/2007 |
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
K072800 |
10/01/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
K042910 |
10/21/2004 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
VELOCIMED INC. |
K023548 |
10/22/2002 |
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 |
VELOCIMED |
K043084 |
11/08/2004 |
PREMERE DELIVERY SHEATH, MODEL PDS |
VELOCIMED INC. |
K003326 |
10/24/2000 |
FUNET AMY MAMA BODY THERMOMETER |
FUNAI RADIO & COMMUNICATIONS CORP. |
K130174 |
01/24/2013 |
DVTCARE CA5 |
OSSUR AMERICAS INC |
K051264 |
05/16/2005 |
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS |
UNOMEDICAL A/S |
K142620 |
09/16/2014 |
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe |
Excelsior Medical Corporation |
K082837 |
09/26/2008 |
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
EXCELSIOR MEDICAL CORP. |
K133446 |
11/12/2013 |
HEPARIN LOCK / FLUSH SYRINGES |
Excelsior Medical Corporation |
K150312 |
02/09/2015 |
Vdrive system, Vdrive Duo, Vdrive with V-Sono |
STEREOTAXIS, INC. |
K000799 |
03/13/2000 |
BELMONT UNIT, MODEL 2000 SERIES |
BELMONT EQUIPMENT CORP. |
K963699 |
09/16/1996 |
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY |
BELMONT EQUIPMENT CORP. |
K983661 |
10/19/1998 |
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES |
BELMONT EQUIPMENT CORP. |
K990292 |
01/29/1999 |
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN |
OPHTHALMIC CONSULTANTS, INC. |
K140270 |
02/03/2014 |
NEXUS MIDLINE CT CATHETER |
HEALTH LINE INTERNATIONAL CORPORATION |
K990872 |
03/16/1999 |
SCLERAL PLUGS, 19 AND 20 GAUGE |
OPHTHALMIC CONSULTANTS, INC. |
K973624 |
09/23/1997 |
NURSE'S AID PATIENT ROTATION SYSTEM |
AIR MED ASSIST PRODUCTS |
K994367 |
12/27/1999 |
UMBILICAL CORD CLAMP |
MEDICAL SALES CO. |
K120395 |
02/08/2012 |
NERIA MULTI SUBCUTANEOUS INFUSION SET |
UNOMEDICAL DEVICES S.A DE C.V |
K070430 |
02/13/2007 |
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS |
UNOMEDICAL A/S |
K160648 |
03/07/2016 |
MiniMed Quick-Set« MiniMed Sure-T« MiniMed Silhouette« MiniMed Mio« |
UNOMEDICAL A/S |
K040633 |
03/10/2004 |
CLICK-ON |
UNOMEDICAL A/S |
K120872 |
03/22/2012 |
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS |
UNOMEDICAL A/S INFUSION DEVICES |
K041545 |
06/09/2004 |
CONTACT DETACH |
UNOMEDICAL A/S |
K032854 |
09/12/2003 |
UNOMEDICAL MONICA INFUSION SET |
UNOMEDICAL A/S |
K162812 |
10/06/2016 |
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc |
UNOMEDICAL A/S |
|
|