ClearanceBrief
Panels › General Hospital › Product code FPA · Class 2

Set, Administration, Intravascular

Regulation 880.5440

6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 129 in
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock Connector 134 in
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in
Terminated
FPAK954123
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, Spin Lock Connector 122 in
Terminated
FPAK954123
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites, Spin Lock Connector 120 in
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and Ultraport Stopcock 132 in US1501UPHP
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj Sites, Ultraport HF Stopcock, 148 in US1500UPHP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Ultrasite Inj Sites, B/C Valve, 2 N/C Valves Stopcock, 116 in US1500M2HP
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF1500M3HP
Terminated
FPAK931377
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite Inj Site, Spin Lock Connector, 128 in US1506HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve, 2 B/C Valves, 3 Ultrasite Inj Sites, 137 in US1505HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj Sites, Check Valve, B/C Valve 119 in US1500XHP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in V1500HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter, Spin Lock Connector 123 in 1500FHP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133 in 1500HP
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C Valve & Pressure Limited Check Valve 136 in US1500HP
Terminated
FPAK955585
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Ultrasite Injection Site 0.2um Filter Ultrablock Tubing 119 in UV3169F
Terminated
FPAK041490
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter Spin Lock Connector 115 in V7416F
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock Connector 88 in US3110
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F
Terminated
FPAK942988
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in NF3169F
Terminated
FPAK942988
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in SS3169F
Terminated
FPAK942988
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited check valve 122 in V7415F
Terminated
FPAK942988
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F
Terminated
FPAK942988
Jan 22, 2010Exelint International Co.
Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R,
Terminated
FPAK895770
Jan 22, 2010Exelint International Co.
Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
Terminated
FPAK081210
Dec 9, 2009Baxter Healthcare Corp.
Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with
Terminated
FPAK984381
Jul 16, 2009Medtronic MiniMed
Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or M
Terminated
FPAK011071
Jun 29, 2009C.R. Bard, Inc., Urological Division
Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
Terminated
FPAK980992
Jun 24, 2009Arrow International Inc
Arrow Extension sets and accessories for intravascular use.
Terminated
FPAK830755
Jun 24, 2009Arrow International Inc
Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits.
Terminated
FPAK830755
Jun 5, 2009B. Braun Medical, Inc.
ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Injection Sites and Spin-Lock Connector, Catalog # V1443. For use with Secondary Container.
Terminated
FPAK790062
Jun 5, 2009B. Braun Medical, Inc.
Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. For use with Secondary Container.
Terminated
FPAK790062
K955585
Jun 5, 2009B. Braun Medical, Inc.
Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, Injection Site, Ultraport High-Flow 4-Way Stopcock with Single Valve Port and Spin-Lock Connector, Catalog # 490
Terminated
FPAK060231
K760383 +1
Jun 5, 2009B. Braun Medical, Inc.
Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046. For use with the Horizon NXT Pump, and OutLook Safety I
Terminated
FPAK904518
K955585

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