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FPA

1,174 FDA 510(k) clearances · Product code

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RecordFirmDate
Paclitaxel Sets (K160007)Baxter Healthcare Corporation2016-12-19
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets (K162304)Quest Medical, Inc.2016-12-06
Solution Set for Epidural Use (K161323)Baxter Healthcare Corporation2016-11-30
LifeFlow Rapid Infusion Device (LifeFlow Device) (K153731)410 Medical Innovation, LLC2016-08-25
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (K153440)C.R. Bard, Inc.2016-08-18
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (K160648)Unomedical A/S2016-08-10
Smart Set (K151250)Top Spins, Inc.2016-06-07
Hospira Administration Sets (K160870)Hospira, Inc.2016-06-01
Orbit Infusion Set (K150921)Ypsomed AG2016-04-12
BD FlowSmart Set, MiniMed Pro-Set (K160651)Becton, Dickinson and Company2016-04-07
Extension Set (K153293)B.Braun Medical, Inc.2016-04-06
Hospira Extension Sets (K151969)Icu Medical, Inc.2016-01-19
Solution Administration Sets with 0.2 Micron Filter (K153158)Baxter Healthcare Corporation2015-12-28
BD FlowSmart Set, MiniMed Pro-Set (K153257)Becton, Dickinson and Company2015-12-11
Q2 Intravenous Adminstration Sets and Extension Sets (K151079)Quest Medical, Inc.2015-09-30
U & U Intravascular Administration Set (K151151)U&U Medical Technology Co, Ltd.2015-09-24
Accu-Chek FlexLink Plus infusion set (K143446)Roche Diagnostics GmbH2015-08-13
IV Administration Sets with 200(micro)m Blood Filter (K143082)B.Braun Medical, Inc.2015-07-24
Imed Technology Intravascular Administration Set, Imed Technology Extension Set (K150513)Imed Technology, Inc.2015-05-28
BD FlowSmart Set (K150059)Becton, Dickinson Company2015-04-28
Nitroglycerin Sets with DUO-VENT Spike (K150860)Baxter Healthcare Corporation2015-04-16
Hospira Blood Set (K143087)Hospira, Inc.2015-03-04
Hospira Primary Sets (K143015)Hospira, Inc.2015-02-25
BUSSE EXTENSION SET (K141285)Busse Hospital Disposables2015-02-19
All Safe Huber Safety Infusion Set (K142590)Nexus Medical, LLC2015-01-16
IV Administration (K142622)Hospira, Inc.2015-01-15
Extension Sets (K142974)Hospira, Inc.2015-01-09
Hospira Extension Set (K142433)Hospira, Inc.2014-12-08
IV ADMINISTRATION SET WITH HAND PUMP (K140838)B.Braun Medical, Inc.2014-12-05
Hospira Primary Sets (K142367)Hospira, Inc.2014-11-25
MaxZero Administration Sets (K143234)Care Fusion2014-11-20
PADI-LOCK (K141200)Padi-Lock, LLC2014-10-02
Extension Set with BD Q-Syte Luer Access Split Septum (K142527)Acacia, Inc.2014-09-19
SELEC-3 I.V.ADMINISTRATION SET (K142097)Biomedix, Inc.2014-08-29
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS (K142036)B.Braun Medical, Inc.2014-08-25
SOLUTION SET/EXTENSION SET (K142011)Baxter Healthcare Corporation2014-08-18
INTRAVASCULAR ADMINISTRATION SET (K140175)Delta Med Spa2014-08-05
SAPPHIRE ADMINISTRATION SET (K141834)Q Core Medical , Ltd.2014-08-05
TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE (K141306)Teva Medical Ltd., Migada Plant2014-06-12
NEXUS NIS-6P LUER ACTIVATED DEVICE (K133351)Nexus Medical, LLC2014-05-22
INFUSET FLOW CONTROL EXTENSION SET (K140133)Emed Technologies Corporation2014-05-15
CARESITE LUER ACCESS DEVICE (K140311)B.Braun Medical, Inc.2014-05-07
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR (K140831)Care Fusion2014-04-15
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET (K140131)Emed Technologies Corporation2014-04-03
CAIR DRIVE, NEUTRACLEAR (K133073)Cair Lgl2014-03-20
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (K133894)Terumo Europe N.V.2014-03-18
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K133867)Terumo Europe N.V.2014-02-05
ZYNO MEDICAL ADMINISTRATION SET (K132841)Zyno Medical, LLC2014-01-23
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (K132880)Medical Components, Inc.2014-01-08
NERIA SOFT 90 INFUSION SET (K132142)Unomedical A/S2013-10-08
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS (K132734)Baxter Healthcare Corp2013-10-08
MZ1000 (K132413)Care Fusion2013-08-29
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS (K130879)Nexus Medical, LLC2013-07-09
NEXUS TKO-6P LUER ACTIVATED DEVICE (K130416)Nexus Medical, LLC2013-06-12
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 (K122404)Repro-Med Systems, Inc. Dba Rms Medical Products2013-05-06
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR (K130023)Np Medical, Inc.2013-04-03
ORBIT INFUSION SET (K130468)Ypsomed AG2013-03-19
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET (K121511)Maclin Power, Inc.2013-03-07
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (K123344)Kawasumi Laboratories, Inc.2013-03-07
TBA (K121269)Migada Plant2013-01-22
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874)Baxter Healthcare Corp2013-01-10
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868)Baxter Healthcare Corp2013-01-08
VERSARATE FLOW RATE CONTROLER (K123729)Emed Technologies Corporation2012-12-21
INTRAVASCULAR ADMINISTRATION SET (K121803)Acta Medical, LLC2012-12-19
ACCU-CHEK ULTRAFLEX INFUSION SET (K122686)Roche Diabetes Care AG2012-11-16
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET (K113471)Nipro Medical Corporation2012-10-18
NIPRO SAFE TOUCH HUBER INFUSION SET (K113470)Nipro Medical Corporation2012-10-17
ZYNO MEDICAL ADMINISTRATION SET (K120685)Zyno Medical, LLC2012-09-07
SAFETY SUBCUTANEOUS TISSUE INFUSION SET (K120195)Multi Med2012-07-06
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR (K121634)Baxter Healthcare Corporation2012-06-29
FLOWEASE [SUBCUTANEOUS] INFUSION SET (K121092)Baxter Healthcare Corp2012-06-29
MED-RX PATIENT DELIVERY SET (K120375)Benlan, Inc.2012-06-28
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP (K121032)Hospira, Inc.2012-06-21
Q-FLO CLOSED MALE LUER CONNECTOR (K121554)Us Fusion, LLC. Dba Truecare Biomedix-USA2012-06-08
NERIA MULTI SUBCUTANEOUS INFUSION SET (K120395)Unomedical Devices S.A DE C.V.2012-05-30
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE (K120443)Baxter Healthcare Corporation - Renal Division2012-05-22
HLIC NEEDLE-LESS VALVE (K120548)Health Line International Corporation2012-05-04
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER (K120261)Perouse Medical2012-05-02
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS (K120872)Unomedical A/S Infusion Devices2012-04-20
NEXUS TKO-6, LUER-ACTIVATED DEVICE (K113398)Nexus Medical, LLC2012-04-18
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... (K112073)Rx Devices, LLC2012-04-11
ARISURE NEUTRAL VALVE (K120799)Yukon Medical, LLC2012-03-30
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL (K113683)Hospira, Inc.2012-01-12
MED-RX EXTENSION SET WITH T-CONNECTOR (K112799)Benlan, Inc.2011-12-23
CYTOGUARD(TM) CLOSED LUER CONNECTOR (K112636)B.Braun Medical, Inc.2011-11-26
VANISHPOINT BLOOD COLLECTION SET (K112512)Retractable Technologies, Inc.2011-10-20
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS (K112893)Baxter Healthcare Corporation2011-10-18
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET (K111351)Us Infusion Dba Truecare Biomedix2011-09-29
INFUSION SET FOR POWERPICC SOLO 2 CATHETER (K102405)C.R. Bard, Inc.2011-07-21
CENTURION PRESSURE INJECTABLE EXTENSION SET (K103562)Centurion Medical Products Corporation2011-06-23
SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (K111016)Elcam Medical Acal2011-06-09
RMS SUBCUTANEOUS NEEDLE SET (K102512)Repro-Med Systems, Inc.2011-05-20
LIGHTY DD INFUSION SET (K110282)Medx-Set, Ltd.2011-04-27
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, (K103551)Baxter Healthcare Corp2011-03-25
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING (K103224)Hospira, Inc.2011-01-07
HIGH PRESSURE SETS-400 PSI (K100576)Icu Medical, Inc.2010-12-17
INFUSION SETS (K103344)Hospira, Inc.2010-12-10
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES (K101368)Dragon Heart Medical, Inc.2010-11-18
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (K100720)Kawasumi Laboratories, Inc.2010-11-18
BLOOD SAMPLING SET (K103165)Acacia, Inc.2010-11-10
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