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 |
|---|---|---|---|
| Jan 8, 2014 | K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE Medical Components, Inc. | FPA |
| Oct 8, 2013 | K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS Baxter Healthcare Corp | FPA |
| Oct 8, 2013 | K132142 | NERIA SOFT 90 INFUSION SET Unomedical A/S, GB | FPA |
| Aug 29, 2013 | K132413 | MZ1000 Care Fusion | FPA |
| Jul 9, 2013 | K130879 | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS Nexus Medical, LLC | FPA |
| Jun 12, 2013 | K130416 | NEXUS TKO-6P LUER ACTIVATED DEVICE Nexus Medical, LLC | FPA |
| May 6, 2013 | K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 Repro-Med Systems, Inc. Dba Rms Medical Products | FPA |
| Apr 3, 2013 | K130023 | K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR Np Medical, Inc. | FPA |
| Mar 19, 2013 | K130468 | ORBIT INFUSION SET Ypsomed AG, CH | FPA |
| Mar 7, 2013 | K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) Kawasumi Laboratories, Inc. | FPA |
| Mar 7, 2013 | K121511 | MACLIN POWER INTRAVASCULAR ADMINISTRATION SET Maclin Power, Inc., IT | FPA |
| Jan 22, 2013 | K121269 | TBA Migada Plant, IL | FPA |
| Jan 10, 2013 | K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S Baxter Healthcare Corp | FPA |
| Jan 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET Baxter Healthcare Corp | FPA |
| Dec 21, 2012 | K123729 | VERSARATE FLOW RATE CONTROLER Emed Technologies Corporation | FPA |
| Dec 19, 2012 | K121803 | INTRAVASCULAR ADMINISTRATION SET Acta Medical, LLC | FPA |
| Nov 16, 2012 | K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET Roche Diabetes Care AG, CH | FPA |
| Oct 18, 2012 | K113471 | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET Nipro Medical Corporation | FPA |
| Oct 17, 2012 | K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET Nipro Medical Corporation | FPA |
| Sep 7, 2012 | K120685 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC | FPA |
| Jul 6, 2012 | K120195 | SAFETY SUBCUTANEOUS TISSUE INFUSION SET Multi Med | FPA |
| Jun 29, 2012 | K121634 | INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR Baxter Healthcare Corporation | FPA |
| Jun 29, 2012 | K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET Baxter Healthcare Corp | FPA |
| Jun 28, 2012 | K120375 | MED-RX PATIENT DELIVERY SET Benlan, Inc., CA | FPA |
| Jun 21, 2012 | K121032 | PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP Hospira, Inc. | FPA |
| Jun 8, 2012 | K121554 | Q-FLO CLOSED MALE LUER CONNECTOR Us Fusion, LLC. Dba Truecare Biomedix-USA | FPA |
| May 30, 2012 | K120395 | NERIA MULTI SUBCUTANEOUS INFUSION SET Unomedical Devices S.A DE C.V., MX | FPA |
| May 22, 2012 | K120443 | NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE Baxter Healthcare Corporation - Renal Division | FPA |
| May 4, 2012 | K120548 | HLIC NEEDLE-LESS VALVE Health Line International Corporation | FPA |
| May 2, 2012 | K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER Perouse Medical, FR | FPA |
| Apr 20, 2012 | K120872 | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS Unomedical A/S Infusion Devices, DK | FPA |
| Apr 18, 2012 | K113398 | NEXUS TKO-6, LUER-ACTIVATED DEVICE Nexus Medical, LLC | FPA |
| Apr 11, 2012 | K112073 | INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... Rx Devices, LLC | FPA |
| Mar 30, 2012 | K120799 | ARISURE NEUTRAL VALVE Yukon Medical, LLC | FPA |
| Jan 12, 2012 | K113683 | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL Hospira, Inc. | FPA |
| Dec 23, 2011 | K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR Benlan, Inc., CA | FPA |
| Nov 26, 2011 | K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR B.Braun Medical, Inc. | FPA |
| Oct 20, 2011 | K112512 | VANISHPOINT BLOOD COLLECTION SET Retractable Technologies, Inc. | FPA |
| Oct 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS Baxter Healthcare Corporation | FPA |
| Sep 29, 2011 | K111351 | TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET Us Infusion Dba Truecare Biomedix | FPA |
| Jul 21, 2011 | K102405 | INFUSION SET FOR POWERPICC SOLO 2 CATHETER C.R. Bard, Inc. | FPA |
| Jun 23, 2011 | K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET Centurion Medical Products Corporation | FPA |
| Jun 9, 2011 | K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) Elcam Medical Acal, IL | FPA |
| May 20, 2011 | K102512 | RMS SUBCUTANEOUS NEEDLE SET Repro-Med Systems, Inc. | FPA |
| Apr 27, 2011 | K110282 | LIGHTY DD INFUSION SET Medx-Set, Ltd. | FPA |
| Mar 25, 2011 | K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, Baxter Healthcare Corp | FPA |
| Jan 7, 2011 | K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc. | FPA |
| Dec 17, 2010 | K100576 | HIGH PRESSURE SETS-400 PSI Icu Medical, Inc. | FPA |
| Dec 10, 2010 | K103344 | INFUSION SETS Hospira, Inc. | FPA |
| Nov 18, 2010 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES Dragon Heart Medical, Inc. | FPA |
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