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849 FDA 510(k) clearances · Product code

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RecordFirmDate
MODIFICATION TO PLUM XL INFUSION PUMP (K010924)Abbott Laboratories2001-04-06
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (K003611)Breg, Inc.2000-12-13
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP (K003616)Baxter Healthcare Corp2000-12-12
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 (K003582)Fluidsense Corp.2000-12-05
INFUSOMAT P (K003029)B.Braun Medical, Inc.2000-12-04
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679)Baxter Healthcare Corp2000-09-18
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM (K002380)Baxter Healthcare Corp2000-09-05
PARADIGM 1.5ML RESERVOIR, MODEL 326 (K001828)Minimed, Inc.2000-08-18
MINIMED PARADIGM INSULIN PUMP, MODEL 511 (K001829)Minimed, Inc.2000-08-18
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS (K993524)Alaris Medical Systems, Inc.2000-08-01
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 (K002211)Baxter Healthcare Corp2000-07-28
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP (K002126)Abbott Laboratories2000-07-20
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM (K001629)Disetronic Medical Systems AG2000-06-21
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM (K000842)Sims Deltec, Inc.2000-06-08
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) (K994274)Quest Medical, Inc.2000-05-31
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (K000328)Medex, Inc.2000-05-09
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION (K000821)Abbott Laboratories2000-03-24
HORIZON LIGHT (K994375)B.Braun Medical, Inc.2000-03-08
SOAKER CATHETER (K994374)I-Flow Corp.2000-03-03
SIMS PORTEX ANESTHESIA CATHETER (K994275)Sims Portex, Inc.2000-02-22
3.0 ML RESERVOIR, MODEL 103/193 (K991936)Medtronic Minimed2000-01-18
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB (K994039)Abbott Laboratories1999-12-22
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K (K993387)Baxter Healthcare Corp1999-11-01
IRRIGATION OR INFUSION PUMP K PUMP (K991203)Kmi Kolster Methods, Inc.1999-10-15
INFUSION DYNAMICS POWER INFUSER MODEL M100B (K992044)Infusion Dynamics, Inc.1999-09-08
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (K991437)Wells Johnson Co.1999-08-30
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) (K992672)Belmont Instrument Corp.1999-08-24
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS (K991275)Mckinley, Inc.1999-07-01
MINIMED 407C INFUSION PUMP, MODEL 407C (K991013)Medtronic Minimed1999-06-23
ACCLAIM INFUSION PUMP (K991501)Abbott Laboratories1999-05-13
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU (K991363)Sorenson Medical, Inc.1999-05-13
1000 PRESSURE INFUSION SIGMACON 1000 (K990447)Valley West, Inc.1999-05-12
SIDEKICK INFUSION KIT (K990425)I-Flow Corp.1999-04-23
MEDEX 3000 SERIES SYRINGE INFUSION PUMP (K982640)Medex, Inc.1999-04-06
PEREGRINE WET SET, MODEL PD400.00 (K990518)Peregrine Surgical , Ltd.1999-03-25
PAIN CONTROL INFUSION PUMP (K990101)Sgarlato Laboratories, Inc.1999-03-19
SABRATEK 4040 INFUSION PUMP (K980751)Sabratek Corp.1999-02-24
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM (K990259)Disetronic Medical Systems1999-02-12
PERFUSOR COMPACT (K983005)B.Braun Medical, Inc.1999-02-04
ABBOTT PLUM A+ INFUSION PUMP (K982159)Abbott Laboratories1999-01-12
VARIABLE PRESSURE SYRINGE PUMP (K974332)Alaris Medical Systems, Inc.1998-12-29
MELODIE INFUSION PUMP (K980378)Compagnie DE Developpement Aguettant1998-12-09
CUE AMBULATORY VOLUMETRIC INFUSION PUMP (K981816)Becton Dickinson Curlin, LLC1998-12-04
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) (K983975)Belmont Instrument Corp.1998-11-30
FLUIDSENSE FLUID DELIVERY SYSTEM (K982170)Fluidsense Corp.1998-11-30
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (K983838)Abbott Laboratories1998-11-20
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 (K982838)Sims Deltec, Inc.1998-11-04
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM (K982836)Sims Deltec, Inc.1998-11-02
MICROFUSE DUAL RATE INFUSER (K983321)Baxa Corp.1998-10-06
METRON QA-IDS I.V. PUMP TESTER (K982020)Metron U.S., Inc.1998-09-30
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 (K973593)Bridge Medical, Inc.1998-08-25
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X (K981776)Alexander Mfg. Co.1998-08-03
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION (K980738)Byron Medical1998-06-16
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 (K980089)Valley West, Inc.1998-03-24
ABBOTT GEMSTAR IV INFUSION PUMP (K974778)Abbott Laboratories1998-03-17
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS (K980092)Smith & Nephew, Inc.1998-03-09
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM (K973917)Sims Deltec, Inc.1998-01-09
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 (K973851)Alexander Mfg. Co.1998-01-05
IDA-4 AND IPT-MC (K973609)Bio-Tek Instruments, Inc.1997-12-18
FLUID MANAGEMENT SYSTEM (K972284)Belmont Instrument Corp.1997-11-13
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS (K972678)Mcgaw, Inc.1997-10-07
BIG BAG 3000 PRESSURE INFUSOR (K973133)Byron Medical1997-09-12
PULSE*SPRAY INJECTOR (K963574)AngioDynamics, Inc.1997-07-18
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (K965230)Abbott Mfg., Inc.1997-07-03
MODELS IDA-2 PLUS AND IPT-1 (K961862)Bio-Tek Instruments, Inc.1997-02-26
DISETRONIC D-MODEM (K961975)Disetronic Medical Systems1997-01-30
GEMINI PC-ITX (K960512)Imed Corp.1996-11-21
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ (K962709)Sigma Intl.1996-10-07
MODEL 1200 ABMULATORY INFUSION PUMP (K961263)Patient Solutions, Inc.1996-08-23
CADD-PRIZM MODEL 6100 PUMP (K960826)Sims Deltec, Inc.1996-08-23
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (K955231)Medex, Inc.1996-07-18
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) (K961703)Baxter Healthcare Corp1996-07-08
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK (K960957)Sims Deltec, Inc.1996-06-04
3030 INFUSION PUMP (K955258)Sabratek Corp.1996-06-03
DISETRONIC MULTIFUSE PUMP SYSTEM (K954826)Disetronic Medical Systems1996-05-24
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP (K955180)Sims Deltec, Inc.1996-05-23
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS (K953896)Imed Corp.1996-03-20
UNIMED MEDICAL DISPENSING PUMP (K952967)A.Z.E. Medical, Inc.1996-02-09
ABBOTT XL3M INFUSION PUMP (K952799)Abbott Laboratories1996-01-18
VOLUMETRIC INFUSION PUMP (K953098)Baxter Healthcare Corp1995-12-22
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) (K953731)Abbott Laboratories1995-12-13
SMARTDOSE IV PREFILLED INFUSION CONTAINER (K944351)River Medical, Inc.1995-11-15
SMARTDOSE III INFUSION CONTAINER (K944352)River Medical, Inc.1995-11-15
ACCUPUMP 901 (MODEL NUMBERS 50 & 100) (K953382)Pharmaceutical Infusion Technologies, Inc.1995-10-17
PLUM XL INFUSION PUMP (MODIFICATION) (K953660)Abbott Laboratories1995-10-17
DISETRONIC D-MODEM (K943952)Disetronic Medical Systems1995-10-07
MODEL 1100 MEDMATE INFUSION PUMP (K953270)Patient Solutions, Inc.1995-10-07
ADI SYSTEM (K933825)Abbott Laboratories1995-09-19
HARVARD 2 SYRINGE PUMP (K952794)Harvard Apparatus, Inc.1995-09-15
9000 INFUSION PUMP (K944721)Graseby Medical , Ltd.1995-08-11
FLEXIFLO QUANTUM ENTERAL PUMP (K944669)Abbott Mfg., Inc.1995-07-24
AUTO SYRINGE(R) AS50 INFUSION PUMP (K945942)Baxter Healthcare Corp1995-07-10
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419)Imed Corp.1995-06-21
CORFLO 300 PUMP (K944750)Corpak, Inc.1995-06-19
LIFECARE 175 INFUSER, MODIFICATION (K944190)Abbott Laboratories1995-05-23
SMART DOSE(TM) (K943692)River Medical, Inc.1995-04-28
SIGMA 8000 AND SIGMA 8002 (K950766)Sigma Intl. General Medical Apparatus, Inc.1995-03-22
POCKET PUMP (K942378)Baxa Infusion Systems1995-03-01
PLUM XL INFUSION PUMP (K944733)Abbott Laboratories1995-02-08
MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5 (K941595)Microject, Inc.1994-12-19
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