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 |
|---|---|---|---|
| Dec 10, 1996 | K960771 | SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc. | FPA |
| Nov 15, 1996 | K955775 | SAFECONNECT VALVE (CATALOG NO. XXXX) Faulding Medical Device Co. | FPA |
| Nov 8, 1996 | K963112 | MMG MULTI LUMON EXTENSION SET Mmg Healthcare, Inc. | FPA |
| Oct 29, 1996 | K960431 | PRESSURE STOPCOCK/MANIFOLD Scientific Device Manufacturer, LLC | FPA |
| Oct 18, 1996 | K963009 | DELTEC SUBCUTANEOUS INFUSION SET Sims Deltec, Inc. | FPA |
| Oct 18, 1996 | K962893 | INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE Baxter Healthcare Corp | FPA |
| Sep 18, 1996 | K961049 | FLEX NEEDLE Lighthouse Medical, Inc. | FPA |
| Sep 16, 1996 | K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 Biomedix, Inc. | FPA |
| Sep 13, 1996 | K963070 | VENIPUNCTURE KIT Miller Products and Services | FPA |
| Aug 28, 1996 | K962802 | SAFE MATE I.V. FLUID DELIVERY SETS Biological & Environmental Control Laboratories | FPA |
| Aug 28, 1996 | K962801 | SAFE MATE I.V. EXTENSION SETS Biological & Environmental Control Laboratories | FPA |
| Aug 1, 1996 | K961794 | FLUID ADMINISTRATION SET - CONTRAST MANAGER Merit Medical Systems, Inc. | FPA |
| Jul 10, 1996 | K955821 | I.V. ADMINISTRATION SETS Medical Associates Network, Inc. | FPA |
| Jul 3, 1996 | K960391 | STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 Strato/Infusaid, Inc. | FPA |
| Jun 26, 1996 | K961495 | HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE Baxter Healthcare Corp | FPA |
| Jun 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp | FPA |
| May 29, 1996 | K954283 | ENERGIZED CONTAINER SYSTEM (MODIFICATION) Abbott Laboratories | FPA |
| May 15, 1996 | K961327 | BEC NEEDLELESS INJECTION SITE Biological & Environmental Control Laboratories | FPA |
| May 15, 1996 | K955585 | V2 INJECTION SITE B.Braun Medical, Inc. | FPA |
| May 6, 1996 | K961474 | POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133 Medtronic Minimed | FPA |
| May 6, 1996 | K955410 | SNAPDOSE DEVICE Abbott Laboratories | FPA |
| Apr 23, 1996 | K954883 | FREE FLOW SAFETY DEVICE Migada, Inc. | FPA |
| Apr 4, 1996 | K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y | FPA |
| Mar 21, 1996 | K960661 | MAXCESS NEEDLE FREE CONNECTOR (8200) Solopak Medical Products, Inc. | FPA |
| Feb 26, 1996 | K953825 | ANGIOFLUSH II FLUID MANAGEMENT SYSTEM AngioDynamics, Inc. | FPA |
| Feb 22, 1996 | K954969 | POLYFIN QR SUBCUTANEOUS INFUSION SET Medtronic Minimed | FPA |
| Feb 21, 1996 | K955732 | VENTED SOLUTION SET Distronic Sterile Products, Inc. | FPA |
| Feb 21, 1996 | K955709 | WINGED & SUBCUTANEOUS INFUSION SETS Distronic Sterile Products, Inc. | FPA |
| Feb 16, 1996 | K952852 | NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET Critical Device Corp. | FPA |
| Feb 7, 1996 | K955783 | VLV SA.EF INFUSION PORT EXTENSION SETS Vlv Associates, Inc. | FPA |
| Jan 30, 1996 | K954823 | VENIPUNCTURE KIT Winfield Industries | FPA |
| Jan 26, 1996 | K953746 | ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET Arrow Intl., Inc. | FPA |
| Jan 23, 1996 | K954983 | EXTENSION SET WITH CHECK VALVE Distronic Sterile Products, Inc. | FPA |
| Jan 23, 1996 | K940832 | I.V. ADMINISTRATION SET CONNECTING DEVICE Sierra Medical Devices | FPA |
| Dec 18, 1995 | K950970 | INFUSION SET Surgiplast , Ltd., IN | FPA |
| Dec 15, 1995 | K954870 | SIMS DELTEC ANTI-SIPHON VALVE Sims Deltec, Inc. | FPA |
| Dec 11, 1995 | K954841 | MODEL D-285N ADMINISTRATION SET Patient Solutions, Inc. | FPA |
| Nov 29, 1995 | K954813 | ICU EXTENSION KIT Icu Medical, Inc. | FPA |
| Nov 21, 1995 | K954123 | LOW PROFILE SAFSITE Y-SITE B.Braun Medical, Inc. | FPA |
| Oct 30, 1995 | K953791 | VLV SA EF INFUSION PORT Vlv Associates, Inc. | FPA |
| Oct 26, 1995 | K953343 | NEEDLELESS INJECTION SITE Medical Associates Network, Inc. | FPA |
| Oct 24, 1995 | K953584 | LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG Abbott Laboratories | FPA |
| Oct 17, 1995 | K951665 | PP-SPF1 / PP-SPF2 Patriot Products, Inc. | FPA |
| Oct 2, 1995 | K953474 | IV START KIT Medikmark, Inc. | FPA |
| Sep 27, 1995 | K953225 | IVAC BALL VALCE ADMIN. SETS Y | FPA |
| Sep 27, 1995 | K933898 | HUBER NEEDLE SETS Mediziv Medical Products 1987 , Ltd., IL | FPA |
| Sep 21, 1995 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) Medex, Inc. | FPA |
| Sep 15, 1995 | K952976 | PLASTIC BLUNT CANNULA Marquette Medical, Inc. | FPA |
| Sep 15, 1995 | K952242 | TRANSFEER SPIKE II The Medi-Dose Group | FPA |
| Sep 8, 1995 | K952810 | DOSI-FLOW, MODELS 20 & 30 Leventon, S.A., ES | FPA |
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