FDA 510(k) Applications Submitted by ROBERT J BARD, JD, RAC, CQE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K101338 |
05/12/2010 |
NEWFIX EXTERNAL FIXATION SYSTEM |
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
| K990425 |
02/11/1999 |
SIDEKICK INFUSION KIT |
I-FLOW CORP. |
| K140671 |
03/18/2014 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE |
OMEGA LABORATORIES, INC. |
| K001106 |
04/05/2000 |
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 |
CREATIVE PLASTIC TECHNOLOGY |
| K101059 |
04/15/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
| K991513 |
04/30/1999 |
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO |
I-FLOW CORP. |
| K141342 |
05/21/2014 |
WEARABLE THERAPY GARMENTS |
AXIOBIONICS LLC |
| K972173 |
06/09/1997 |
MEDI-SIS SYRINGE INFUSION SYSTEM |
I-FLOW CORP. |
| K041585 |
06/14/2004 |
AUTOFUSER AMBULATORY INFUSION PUMP |
ALGOS, LC |
| K992072 |
06/19/1999 |
BOLUS ACCESSORY SET |
I-FLOW CORP. |
| K101973 |
07/13/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) |
OMEGA LABORATORIES, INC. |
| K002142 |
07/17/2000 |
SALINE IV FLUSH SYRINGE |
EMT-RX |
| K122210 |
07/25/2012 |
NEWFIX EXTERNAL FIXATION SYSTEM |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
| K982946 |
08/21/1998 |
PAINBUSTER INFUSION KIT |
I-FLOW CORP. |
| K122759 |
09/10/2012 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) |
OMEGA LABORATORIES, INC. |
| K112808 |
09/27/2011 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
OMEGA LABORATORIES, INC. |
| K023491 |
10/17/2002 |
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM |
HELP TECHNOLOGIES |
| K093475 |
11/06/2009 |
BASESENS BLOOD GLUCOSE MONITORING SYSTEM |
HYGEIA, INC. |
| K984063 |
11/16/1998 |
PARAGON BASAL/BOLUS ADMINISTRATION SET |
I-FLOW CORP. |
| K984146 |
11/19/1998 |
PARAGON INFUSION |
I-FLOW CORP. |
| K023863 |
11/20/2002 |
AUTOMED 3000 INFUSION PUMP |
HELP TECHNOLOGIES |
| K023973 |
12/02/2002 |
AUTOMED 3200 INFUSION PUMP |
HELP TECHNOLOGIES |
| K955727 |
12/18/1995 |
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET |
I-FLOW CORP. |
| K984502 |
12/18/1998 |
NERVE BLOCK INFUSION KIT |
I-FLOW CORP. |
| K003915 |
12/19/2000 |
ACCUFUSER; ACCUFUSER PLUS |
HELPTECHNOLOGIES |
| K984638 |
12/31/1998 |
PARAGON BOLUS ACCESSORY SET |
I-FLOW CORP. |
| K980558 |
02/13/1998 |
PAINBUSTER INFUSION SYSTEM |
I-FLOW CORP. |
| K131128 |
04/23/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
OMEGA LABORATORIES, INC. |
| K101254 |
05/04/2010 |
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
| K103161 |
10/27/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES |
OMEGA LABORATORIES, INC. |
| K130023 |
01/03/2013 |
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR |
NP MEDICAL, INC. |
| K131181 |
04/25/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
|
|
