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FPA

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

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RecordFirmDate
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS (K102073)Benlan, Inc.2010-11-08
K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) (K102890)Kawasumi Laboratories America, Inc.2010-10-21
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (K101958)Amsino International, Inc.2010-09-29
ACCU-CHEK ULTRFLEX INFUSION SET (K101196)Roche Diagnostics Corp.2010-08-27
HOSPIRA INFUSION BLOOD SETS (K101677)Hospira, Inc.2010-08-11
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, (K101180)Smiths Medical MD, Inc.2010-08-03
INTRAVSCULAR ADMINISTRATION SET (K100946)Terumo Europe N.V.2010-08-02
IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY (K093489)Rymed Technologies, Inc.2010-07-29
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09
CLAVE NEUTRON (K100434)Icu Medical, Inc.2010-07-09
DUAL LUER LOCK CAP, MODEL 2C6250 (K101385)Baxter Healthcare Corp2010-06-22
NEXUS PRESSURE RATED EXTENSION SETS (K092382)Nexus Medical, LLC2010-04-26
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED (K092930)Nexus Medical, LLC2010-03-10
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS (K093773)Amsino International, Inc.2010-03-10
AUTOSTART BURETTE (K092905)Analytica Pty, Ltd.2010-03-04
NEXUS INJECTION SITE, MODEL NIS-8 (K092527)Nexus Medical, LLC2010-02-04
EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD (K093271)Victus, Inc.2010-01-27
EXEL I.V. EXTENSION SET (K092172)Exelint Intl. Co.2010-01-04
DISPOSABLE TPE INFUSION SET (K090459)Shan Dong Wei Gao Group Medical Polymer Products2009-10-13
BAIXIN INTRAVASCULAR ADMINISTRATION SET (K083687)Anhui Kangda Medical Products Co., Ltd.2009-06-11
DISPOSABLE INFUSION SET (K090012)Shan Dong Wei Gao Group Medical Polymer Products2009-06-11
A6 LUER ACCESS DEVICE (K083723)B.Braun Medical, Inc.2009-06-05
MPS ACACIA POWER INJECTABLE INFUSION SET (K090809)Mps Acacia2009-04-28
INTRAVENOUS POWER INJECTOR EXTENSION SET (K090134)C.R. Bard, Inc.2009-04-21
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE (K090189)Icu Medical, Inc.2009-04-10
SPINNING SPIROS, MODEL CH-2000 (K082806)Icu Medical, Inc.2009-04-06
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (K083482)Cook Vascular, Inc.2009-04-02
FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 (K082027)Genesis Bps, LLC2009-02-13
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL (K083765)Medegen Medical Manufacturing Services2008-12-30
MISER CONTRAST MANAGEMENT SYSTEM (K083576)Merit Medical Systems, Inc.2008-12-23
SUBCUTANEOUS NEEDLE INFUSION SET (K082818)Marcal Medical, Inc.2008-12-23
MEDEGEN PRESSURE RATED EXTENSION SETS (K083472)Medegen, Inc.2008-12-09
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (K081123)Nexus Medical, LLC2008-11-14
NIPRO SAFETOUCH HUBER INFUSTION SET (K081210)Nipro Medical Corp.2008-10-21
POWERLOC CLEAR SAFETY INFUSION SET (K082306)C.R. Bard, Inc.2008-08-28
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX (K081361)Icu Medical, Inc.2008-08-28
TRITON MEIDCAL TMED IV-SET (K073444)Triton Medical, LLC2008-08-18
UNASSIGNED (K080544)Medcomp2008-08-14
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG (K073396)B.Braun Medical, Inc.2008-08-07
EZ REGULAR (K080303)Meinntech Co., Ltd.2008-08-05
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE (K081289)Baxter Healthcare Corp2008-08-04
CADD MEDICATION CASSETTE RESERVOIR (K081156)Smiths Medical MD, Inc.2008-07-18
MOBILE I.V. SYSTEMS 10,20,60 (K080695)Northwind Technologies, Corp.2008-07-01
NOVOLET (K080665)U.S. Safety Syringes Co., Inc.2008-05-13
IV ADMINISTRATION SET (K080660)U.S. Safety Syringes Co., Inc.2008-05-13
SAFESTEP MAX POWER-INJECTABLE INFUSION SET (K073050)Specialized Health Products International, Inc.2008-01-25
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET (K072375)AngioDynamics, Inc.2007-12-13
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K072894)Terumo Europe N.V.2007-11-06
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED (K072576)Baxter Healthcare Corp2007-11-06
POLYPERF / POLYPERF SAFE (K063631)Laboratoires Perouse2007-10-05
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K071421)Promepla2007-10-04
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K072542)Medegen Medical Manufacturing System2007-09-25
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE (K070630)Health Line International Corporation (Hlic)2007-08-31
MODIFICATION TO EZ HUBER SAFETY INFUSION SET (K071846)Pfm Medical, Inc.2007-08-30
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) (K070547)Terumo Europe N.V.2007-05-25
IMM HYPODERMIC NEEDLE SET (K070801)Innovative Medical Manufacturing Co.2007-05-24
SURFLO WINGED INFUSION SET (K070362)Terumo Europe N.V.2007-05-07
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (K070430)Unomedical A/S2007-04-04
LMT-KATH-S; LMT-KATH-I (K062308)Licher Medizintechnologie GmbH2007-03-20
SPIROS (K070532)Icu Medical, Inc.2007-03-20
REPEATER PUMP II TUBE SETS (K062909)Baxa Corp.2007-03-09
ACCU-CHEK ULTRAFLEX INFUSION SET (K070189)Disetronic Medical Systems AG2007-02-21
INTUITION INFUSION SETS (K061374)Unomedical A/S2006-07-31
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (K061285)Cardinal Health, Alaris Products2006-07-26
EZ-CONNECT (K061771)Vidacare Corporation2006-07-10
SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 (K061115)Gvs Spa2006-06-30
DERMATECH IV HOLDER (K060488)Dermatech Medical, Inc.2006-06-08
K-SHIELD PORT ACCESS INFUSION SET (K060580)Kawasumi Laboratories, Inc.2006-06-06
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS (K060352)Health Line International Corporation2006-05-31
ONE STICK Y EXTENSION SET AND VOLUMETER (K060672)One Stick, LLC2006-03-31
TIANJIN MEDIS DISPOSABLE INFUSION SET (K060082)Tianjin Medis International Trade Co., Ltd.2006-03-31
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 (K060074)Baxter Healthcare Corp2006-03-29
ALARIS SAFETY MALE LUER (K053049)Cardinal Health, Alaris Products2006-01-12
TEGO, MODEL D1000 (K053106)Icu Medical, Inc.2006-01-10
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS (K052887)Terumo Europe N.V.2005-12-08
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 (K053129)Nexus Medical, LLC2005-12-08
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 (K052432)Medtronic Minimed2005-11-29
CONTRAST MEDIA TRANSFER SETS (K052252)B.Braun Medical, Inc.2005-11-16
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS (K052722)Hospira, Inc.2005-11-02
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET (K052658)Renascence Medical, Inc.2005-10-12
SUREFLOW SAFETY INFUSION DEVICE (K051943)Intrasafe Medical, LLC2005-10-04
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (K051264)Unomedical A/S2005-09-01
VITALCARE I.V. ADMINISTRATION SET (K050906)Vitalcare Group, Inc.2005-08-23
CML 1000 (K051437)Icu Medical, Inc.2005-08-03
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K051939)Medegen Medical Manufacturing System2005-08-01
ANGIODYNAMICS TUMESCENT INFUSION DEVICE (K051142)AngioDynamics, Inc.2005-07-13
HUBER CLEAR SAFETY INFUSION SET (K051009)Now Medical Distribution, Inc.2005-07-12
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499)Medegen Medical Manufacturing Services2005-06-22
MINILOC SAFETY INFUSION SET (K050600)Specialized Health Products, Intl.2005-05-12
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS (K041495)Pentaferte S.P.A2005-04-15
MICROFLO-SAFE SCALP VEIN SET (K043328)Dks Loversan Industria Biomedica Spa2005-04-15
BD POSIFLOW POSITIVE DISPLACEMENT VALVE (K050207)Becton Dickinson Infusion Therapy Systems, Inc.2005-04-07
DRAGON HEART I.V. SET (K043235)Dragon Heart Medical Devices Co., Ltd.2005-03-08
F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK (K042129)Cedic S.R.L.2005-01-27
LUTH-ALL SUB-Q NEEDLE SET (K042666)Luth-All Medical Products, LLC2004-12-21
NEXUS INTRAVENOUS TUBING SETS (NIVTS) (K041861)Nexus Medical, LLC2004-11-26
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE (K042936)Baxter Healthcare Corp2004-11-26
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING (K041490)B.Braun Medical, Inc.2004-10-29
IV ADMINISTRATION SET B400 SP (K042693)Codan US Corp.2004-10-21
CLEO 90 INFUSION SET (K042172)Smiths Medical MD, Inc.2004-10-07
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