FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K022203 |
ABBOTT LABORATORIES |
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 |
08/01/2002 |
K032233 |
ALARIS MEDICAL SYSTEMS, INC. |
MEDLEY PCA MODULE, MODEL 8120 |
09/09/2003 |
K043299 |
ALARIS MEDICAL SYSTEMS, INC. |
MEDLEY PCA MODULE, MODEL 8120 |
12/10/2004 |
K990312 |
AMTEC MEDICAL |
AVIA PAIN MEDICATION DELIVERY SYSTEM |
04/22/1999 |
K092313 |
B. BRAUN MEDICAL, INC. |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
11/04/2009 |
K002739 |
BAXTER HEALTHCARE CORP. |
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K |
09/11/2000 |
K051253 |
BAXTER HEALTHCARE CORP. |
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) |
07/15/2005 |
K031566 |
BAXTER HEALTHCARE CORP. |
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 |
08/19/2003 |
K013822 |
CANE SRL |
MICROJET CRONO PCA |
05/08/2002 |
K033054 |
HARVARD CLINICAL TECHNOLOGY |
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP |
12/16/2003 |
K020421 |
HENNIG ENTERPRISES EUROPE S.R.L. |
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
04/29/2003 |
K143612 |
Hospira, Inc |
LifeCare PCA Infusion System |
04/08/2016 |
K043256 |
HOSPIRA, INC. |
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 |
12/06/2004 |
K042800 |
HOSPIRA, INC. |
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
10/18/2004 |
K020418 |
P.T. GREENLEAF |
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
04/29/2003 |
K982839 |
SIMS DELTEC, INC. |
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 |
11/02/1998 |
K170982 |
Smiths Medical ADS, Inc. |
CADD«- Solis Ambulatory Infusion Pump with Wireless Communication; CADD«-Solis Infusion Pump, Model 2110; PharmGuard« Administrator Medication Safety Software; CADD« Administration Sets; Wireless Communication Module (CM) |
08/24/2017 |
K130394 |
SMITHS MEDICAL ASD, INC. |
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 |
12/09/2013 |
K072144 |
SMITHS MEDICAL MD, INC. |
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR |
03/07/2008 |
K002434 |
SORENSON MEDICAL, INC. |
PALM PUMP |
08/23/2000 |
K030661 |
STRYKER INSTRUMENTS |
STRYKER PAINPUMP2 |
05/30/2003 |
K162165 |
SUMMIT MEDICAL PRODUCTS, INC |
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump |
08/29/2017 |