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 6, 2007 | K072576 | CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED Baxter Healthcare Corp | FPA |
| Oct 5, 2007 | K063631 | POLYPERF / POLYPERF SAFE Laboratoires Perouse, FR | FPA |
| Oct 4, 2007 | K071421 | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Promepla | FPA |
| Sep 25, 2007 | K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR Medegen Medical Manufacturing System | FPA |
| Aug 31, 2007 | K070630 | HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE Health Line International Corporation (Hlic) | FPA |
| Aug 30, 2007 | K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET Pfm Medical, Inc. | FPA |
| May 25, 2007 | K070547 | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| May 24, 2007 | K070801 | IMM HYPODERMIC NEEDLE SET Innovative Medical Manufacturing Co. | FPA |
| May 7, 2007 | K070362 | SURFLO WINGED INFUSION SET Terumo Europe N.V., BE | FPA |
| Apr 4, 2007 | K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS Unomedical A/S, DK | FPA |
| Mar 20, 2007 | K070532 | SPIROS Icu Medical, Inc. | FPA |
| Mar 20, 2007 | K062308 | LMT-KATH-S; LMT-KATH-I Licher Medizintechnologie GmbH, DE | FPA |
| Mar 9, 2007 | K062909 | REPEATER PUMP II TUBE SETS Baxa Corp. | FPA |
| Feb 21, 2007 | K070189 | ACCU-CHEK ULTRAFLEX INFUSION SET Disetronic Medical Systems AG | FPA |
| Jul 31, 2006 | K061374 | INTUITION INFUSION SETS Unomedical A/S, DK | FPA |
| Jul 26, 2006 | K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS Cardinal Health, Alaris Products | FPA |
| Jul 10, 2006 | K061771 | EZ-CONNECT Vidacare Corporation | FPA |
| Jun 30, 2006 | K061115 | SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 Gvs Spa | FPA |
| Jun 8, 2006 | K060488 | DERMATECH IV HOLDER Dermatech Medical, Inc. | FPA |
| Jun 6, 2006 | K060580 | K-SHIELD PORT ACCESS INFUSION SET Kawasumi Laboratories, Inc. | FPA |
| May 31, 2006 | K060352 | HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS Health Line International Corporation | FPA |
| Mar 31, 2006 | K060672 | ONE STICK Y EXTENSION SET AND VOLUMETER One Stick, LLC | FPA |
| Mar 31, 2006 | K060082 | TIANJIN MEDIS DISPOSABLE INFUSION SET Tianjin Medis International Trade Co., Ltd., CN | FPA |
| Mar 29, 2006 | K060074 | INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 Baxter Healthcare Corp | FPA |
| Jan 12, 2006 | K053049 | ALARIS SAFETY MALE LUER Cardinal Health, Alaris Products | FPA |
| Jan 10, 2006 | K053106 | TEGO, MODEL D1000 Icu Medical, Inc. | FPA |
| Dec 8, 2005 | K053129 | NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 Nexus Medical, LLC | FPA |
| Dec 8, 2005 | K052887 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS Terumo Europe N.V., BE | FPA |
| Nov 29, 2005 | K052432 | MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 Medtronic Minimed | FPA |
| Nov 16, 2005 | K052252 | CONTRAST MEDIA TRANSFER SETS B.Braun Medical, Inc. | FPA |
| Nov 2, 2005 | K052722 | LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS Hospira, Inc. | FPA |
| Oct 12, 2005 | K052658 | SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET Renascence Medical, Inc. | FPA |
| Oct 4, 2005 | K051943 | SUREFLOW SAFETY INFUSION DEVICE Intrasafe Medical, LLC | FPA |
| Sep 1, 2005 | K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS Unomedical A/S, DK | FPA |
| Aug 23, 2005 | K050906 | VITALCARE I.V. ADMINISTRATION SET Vitalcare Group, Inc. | FPA |
| Aug 3, 2005 | K051437 | CML 1000 Icu Medical, Inc. | FPA |
| Aug 1, 2005 | K051939 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR Medegen Medical Manufacturing System, CA | FPA |
| Jul 13, 2005 | K051142 | ANGIODYNAMICS TUMESCENT INFUSION DEVICE AngioDynamics, Inc. | FPA |
| Jul 12, 2005 | K051009 | HUBER CLEAR SAFETY INFUSION SET Now Medical Distribution, Inc. | FPA |
| Jun 22, 2005 | K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Medegen Medical Manufacturing Services | FPA |
| May 12, 2005 | K050600 | MINILOC SAFETY INFUSION SET Specialized Health Products, Intl. | FPA |
| Apr 15, 2005 | K043328 | MICROFLO-SAFE SCALP VEIN SET Dks Loversan Industria Biomedica Spa | FPA |
| Apr 15, 2005 | K041495 | PENTADEFLUE IV SOLUTION ADMINISTRATION SETS Pentaferte S.P.A, IT | FPA |
| Apr 7, 2005 | K050207 | BD POSIFLOW POSITIVE DISPLACEMENT VALVE Becton Dickinson Infusion Therapy Systems, Inc. | FPA |
| Mar 8, 2005 | K043235 | DRAGON HEART I.V. SET Dragon Heart Medical Devices Co., Ltd. | FPA |
| Jan 27, 2005 | K042129 | F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK Cedic S.R.L., IT | FPA |
| Dec 21, 2004 | K042666 | LUTH-ALL SUB-Q NEEDLE SET Luth-All Medical Products, LLC | FPA |
| Nov 26, 2004 | K042936 | SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE Baxter Healthcare Corp | FPA |
| Nov 26, 2004 | K041861 | NEXUS INTRAVENOUS TUBING SETS (NIVTS) Nexus Medical, LLC | FPA |
| Oct 29, 2004 | K041490 | IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING B.Braun Medical, Inc. | FPA |
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