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)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2010 | K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING Kawasumi Laboratories, Inc. | FPA |
| Nov 10, 2010 | K103165 | BLOOD SAMPLING SET Acacia, Inc. | FPA |
| Nov 8, 2010 | K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS Benlan, Inc. | FPA |
| Oct 21, 2010 | K102890 | K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) Kawasumi Laboratories America, Inc. | FPA |
| Sep 29, 2010 | K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS Amsino International, Inc. | FPA |
| Aug 27, 2010 | K101196 | ACCU-CHEK ULTRFLEX INFUSION SET Roche Diagnostics Corp. | FPA |
| Aug 11, 2010 | K101677 | HOSPIRA INFUSION BLOOD SETS Hospira, Inc. | FPA |
| Aug 3, 2010 | K101180 | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, Smiths Medical MD, Inc. | FPA |
| Aug 2, 2010 | K100946 | INTRAVSCULAR ADMINISTRATION SET Terumo Europe N.V., BE | FPA |
| Jul 29, 2010 | K093489 | IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY Rymed Technologies, Inc. | FPA |
| Jul 9, 2010 | K100434 | CLAVE NEUTRON Icu Medical, Inc. | FPA |
| Jul 9, 2010 | K100432 | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS Medtronic Minimed | FPA |
| Jun 22, 2010 | K101385 | DUAL LUER LOCK CAP, MODEL 2C6250 Baxter Healthcare Corp | FPA |
| Apr 26, 2010 | K092382 | NEXUS PRESSURE RATED EXTENSION SETS Nexus Medical, LLC | FPA |
| Mar 10, 2010 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS Amsino International, Inc. | FPA |
| Mar 10, 2010 | K092930 | NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED Nexus Medical, LLC | FPA |
| Mar 4, 2010 | K092905 | AUTOSTART BURETTE Analytica Pty, Ltd. | FPA |
| Feb 4, 2010 | K092527 | NEXUS INJECTION SITE, MODEL NIS-8 Nexus Medical, LLC | FPA |
| Jan 27, 2010 | K093271 | EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD Victus, Inc. | FPA |
| Jan 4, 2010 | K092172 | EXEL I.V. EXTENSION SET Exelint Intl. Co. | FPA |
| Oct 13, 2009 | K090459 | DISPOSABLE TPE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products, CN | FPA |
| Jun 11, 2009 | K090012 | DISPOSABLE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products, CN | FPA |
| Jun 11, 2009 | K083687 | BAIXIN INTRAVASCULAR ADMINISTRATION SET Anhui Kangda Medical Products Co., Ltd., CN | FPA |
| Jun 5, 2009 | K083723 | A6 LUER ACCESS DEVICE B.Braun Medical, Inc. | FPA |
| Apr 28, 2009 | K090809 | MPS ACACIA POWER INJECTABLE INFUSION SET Mps Acacia | FPA |
| Apr 21, 2009 | K090134 | INTRAVENOUS POWER INJECTOR EXTENSION SET C.R. Bard, Inc. | FPA |
| Apr 10, 2009 | K090189 | ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE Icu Medical, Inc. | FPA |
| Apr 6, 2009 | K082806 | SPINNING SPIROS, MODEL CH-2000 Icu Medical, Inc. | FPA |
| Apr 2, 2009 | K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET Cook Vascular, Inc. | FPA |
| Feb 13, 2009 | K082027 | FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 Genesis Bps, LLC | FPA |
| Dec 30, 2008 | K083765 | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL Medegen Medical Manufacturing Services | FPA |
| Dec 23, 2008 | K083576 | MISER CONTRAST MANAGEMENT SYSTEM Merit Medical Systems, Inc. | FPA |
| Dec 23, 2008 | K082818 | SUBCUTANEOUS NEEDLE INFUSION SET Marcal Medical, Inc. | FPA |
| Dec 9, 2008 | K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS Medegen, Inc. | FPA |
| Nov 14, 2008 | K081123 | NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS Nexus Medical, LLC | FPA |
| Oct 21, 2008 | K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET Nipro Medical Corp. | FPA |
| Aug 28, 2008 | K082306 | POWERLOC CLEAR SAFETY INFUSION SET C.R. Bard, Inc. | FPA |
| Aug 28, 2008 | K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX Icu Medical, Inc. | FPA |
| Aug 18, 2008 | K073444 | TRITON MEIDCAL TMED IV-SET Triton Medical, LLC | FPA |
| Aug 14, 2008 | K080544 | UNASSIGNED Medcomp | FPA |
| Aug 7, 2008 | K073396 | ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG B.Braun Medical, Inc. | FPA |
| Aug 5, 2008 | K080303 | EZ REGULAR Meinntech Co., Ltd. | FPA |
| Aug 4, 2008 | K081289 | V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE Baxter Healthcare Corp | FPA |
| Jul 18, 2008 | K081156 | CADD MEDICATION CASSETTE RESERVOIR Smiths Medical MD, Inc. | FPA |
| Jul 1, 2008 | K080695 | MOBILE I.V. SYSTEMS 10,20,60 Northwind Technologies, Corp. | FPA |
| May 13, 2008 | K080665 | NOVOLET U.S. Safety Syringes Co., Inc. | FPA |
| May 13, 2008 | K080660 | IV ADMINISTRATION SET U.S. Safety Syringes Co., Inc. | FPA |
| Jan 25, 2008 | K073050 | SAFESTEP MAX POWER-INJECTABLE INFUSION SET Specialized Health Products International, Inc. | FPA |
| Dec 13, 2007 | K072375 | SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET AngioDynamics, Inc. | FPA |
| Nov 6, 2007 | K072894 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
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