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 |
|---|---|---|---|
| Feb 19, 2003 | K024363 | NEXUS INJECTION SITE (NIS), MODEL NIS-1 Nexus Medical, LLC | FPA |
| Jan 27, 2003 | K030002 | LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. Abbott Laboratories | FPA |
| Dec 30, 2002 | K023769 | PREPARE ADMINISTRATION SET Appro Healthcare, Inc. | FPA |
| Dec 18, 2002 | K023595 | BURETTE-IN LINE (150 ML) Tuta Healthcare Pty Limited, AU | FPA |
| Dec 10, 2002 | K023469 | VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 Victus, Inc. | FPA |
| Dec 2, 2002 | K020533 | EXEL VACULET BLOOD COLLECTION SET Exelint Intl. Co. | FPA |
| Nov 21, 2002 | K023585 | FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000 Intravascular Incorporated | FPA |
| Nov 14, 2002 | K021565 | LUTHER SAFETY HUBER NEEDLE SET Luther Research Partners | FPA |
| Aug 29, 2002 | K021916 | HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 Harmac Medical Products, Inc. | FPA |
| Aug 29, 2002 | K021080 | NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS Cardio Med Supplies, Inc., CA | FPA |
| Aug 13, 2002 | K021999 | GRIPPER PLUS NEEDLE Deltec, Inc. | FPA |
| Aug 6, 2002 | K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc. | FPA |
| Jul 12, 2002 | K020926 | EXTENSION SET, MODELS 1911-512 Epimed International, Inc. | FPA |
| Jul 8, 2002 | K021488 | SURECAN SAFETY HUBER NEEDLE INFUSION SETS B.Braun Medical, Inc. | FPA |
| Jun 27, 2002 | K021480 | EXTENSION SET LIGHT-SAFE, MODEL BC565 Codan US Corp. | FPA |
| May 21, 2002 | K021530 | SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN Sterling Medivations, Inc. | FPA |
| May 17, 2002 | K021487 | SIMPLICITY EASY ACCESS P INFUSION SET Sterling Medivations, Inc. | FPA |
| May 14, 2002 | K021296 | SIMPLICITY QD EASY P INFUSION SET Sterling Medivations, Inc. | FPA |
| May 13, 2002 | K021395 | MODIFICATION TO 30 EXTENSION SET Churchill Medical Systems, Inc. | FPA |
| May 3, 2002 | K021216 | SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS Sterling Medivations, Inc. | FPA |
| Apr 29, 2002 | K020530 | EVANS SUB-Q, MODEL MC4206 Evans Medical, Inc. | FPA |
| Apr 25, 2002 | K021005 | SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE Sterling Medivations, Inc. | FPA |
| Apr 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 Becton Dickinson Infusion Therapy Systems, Inc. | FPA |
| Apr 10, 2002 | K020990 | SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN Sterling Medivations, Inc. | FPA |
| Apr 10, 2002 | K020912 | SIMPLICITY EASY SOFT INFUSION SET Sterling Medivations, Inc. | FPA |
| Apr 1, 2002 | K020629 | SIMPLICITY SIMPLEX SOFT INFUSION SET Sterling Medivations, Inc. | FPA |
| Mar 29, 2002 | K013871 | LIFEGUARD SAFETY INFUSION SET Horizon Medical Products, Inc. | FPA |
| Mar 28, 2002 | K013714 | CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP Codan US Corp. | FPA |
| Mar 27, 2002 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR Churchill Medical Systems, Inc. | FPA |
| Mar 12, 2002 | K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA Churchill Medical Systems, Inc. | FPA |
| Jan 17, 2002 | K014062 | SIMPLICITY EASY ACCESS INFUSION SET Sterling Medivations, Inc. | FPA |
| Jan 17, 2002 | K014061 | SIMPLICITY STARPLUS SOFT INFUSION SET Sterling Medivations, Inc. | FPA |
| Jan 17, 2002 | K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE Exelint Intl. Co. | FPA |
| Jan 10, 2002 | K013950 | VENTED VIAL ACCESS DEVICE Churchill Medical Systems, Inc. | FPA |
| Dec 3, 2001 | K013502 | SIMPLICITY CLASSIC WING QD INFUSION SET Sterling Medivations, Inc. | FPA |
| Nov 8, 2001 | K013394 | LIFTLOC SAFETY INFUSION SET Specialized Health Products, Inc. | FPA |
| Nov 6, 2001 | K012429 | SURESET INFUSION SET, MODEL 8023 Applied Diabetes Research, Incorporated | FPA |
| Oct 15, 2001 | K013164 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET Terumo Medical Corp. | FPA |
| Oct 2, 2001 | K013104 | SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE Sterling Medivations, Inc. | FPA |
| Sep 27, 2001 | K011405 | EXEL INJECTION PLUG WITH CAP Exelint Intl. Co. | FPA |
| Sep 14, 2001 | K012845 | SIMPLICITY SOFT QD MICRO INFUSION SET Sterling Medivations, Inc. | FPA |
| Sep 14, 2001 | K012526 | BIOTEQUE SCALP VEIN SET Bioteque Corp. | FPA |
| Sep 10, 2001 | K011888 | PRESSURE ACTIVATED CHECK VALVE Churchill Medical Systems, Inc. | FPA |
| Aug 30, 2001 | K010404 | EXEL I.V. ADMINISTRATION SET Exelint Intl. Co. | FPA |
| Aug 27, 2001 | K012754 | EZ SET INFUSION SET Animas Corp. | FPA |
| Aug 10, 2001 | K012330 | SIMPLICITY EURO QD INFUSION SET Sterling Medivations, Inc. | FPA |
| Aug 10, 2001 | K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 Northgate Technologies, Inc. | FPA |
| Jul 18, 2001 | K011216 | PVC FREE INTRAVASCULAR ADMINISTRATION SET Biometrix , Ltd., IL | FPA |
| Jul 9, 2001 | K003254 | CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 Mission Medicl Devices | FPA |
| Jun 27, 2001 | K010888 | SIDEPORT PINCH CLAMP DEVICE Medivice Systems, Ltd., IL | FPA |
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