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 |
|---|---|---|---|
| May 9, 1994 | K925731 | ISOFLUX IXP FLOW REGULATOR Ferguson Medical | FPA |
| May 5, 1994 | K940867 | CONTROL-A-FLO(TM) REGULATOR Baxter Healthcare Corp | FPA |
| May 2, 1994 | K926448 | I.V. ADMINISTRATION SET Gainor Medical Europe, Ltd. | FPA |
| Apr 15, 1994 | K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET Puritas Health Care, Inc. | FPA |
| Apr 15, 1994 | K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH Imed Corp. | FPA |
| Apr 13, 1994 | K932165 | INTRAVASCULAR ADMINISTRATION SET Mcgaw, Inc. | FPA |
| Apr 4, 1994 | K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM Puritas Health Care, Inc. | FPA |
| Mar 28, 1994 | K940053 | INFUSION ADMINISTRATION SET Puritas Health Care, Inc. | FPA |
| Mar 28, 1994 | K933326 | LIFECARE PLUMSET VENTED SECONDARY I.V. SET Abbott Laboratories | FPA |
| Mar 23, 1994 | K940073 | EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30 Puritas Health Care, Inc. | FPA |
| Mar 23, 1994 | K940072 | I.V. SET (20 DROPS/ML) Puritas Health Care, Inc. | FPA |
| Mar 22, 1994 | K940689 | WALL IV EXTENSION TUBE Walla Medical Systems, Inc. | FPA |
| Mar 7, 1994 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT Mcgaw, Inc. | FPA |
| Feb 22, 1994 | K940296 | SAFE CONNECTOR Icu Medical, Inc. | FPA |
| Feb 9, 1994 | K933390 | REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG Pharmacia Deltec, Inc. | FPA |
| Jan 26, 1994 | K932856 | IRRIGATION ACCESS CAP Mcgaw, Inc. | FPA |
| Jan 21, 1994 | K935601 | 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE Puritas Health Care, Inc. | FPA |
| Jan 14, 1994 | K930854 | SOLUTION SET WITH .2 MICRON FILTER Douglas Medical Products Corp. | FPA |
| Jan 10, 1994 | K931550 | EZ ADMINISTRATION SET Y | FPA |
| Jan 7, 1994 | K932637 | SUBCUTANEOUS INFUSION SET Douglas Medical Products Corp. | FPA |
| Jan 7, 1994 | K931659 | 3 LEAD CONNECTOR Douglas Medical Products Corp. | FPA |
| Dec 29, 1993 | K933852 | PRO-LOK EXTENSION SET Beech Medical Products, Inc. | FPA |
| Dec 29, 1993 | K933749 | BEECH VERSA LOK Beech Medical Products, Inc. | FPA |
| Dec 29, 1993 | K933732 | BEECH PROLOK Beech Medical, Inc. | FPA |
| Dec 21, 1993 | K931658 | IN-LINE BURETTE SET Douglas Medical Products Corp. | FPA |
| Dec 14, 1993 | K932638 | HUBER NEEDLE INFUSION SET Douglas Medical Products Corp. | FPA |
| Nov 29, 1993 | K932446 | INJECTION SITE 3M Health Care, Ltd. | FPA |
| Nov 3, 1993 | K931119 | DURHAM; NON CORING WINGED ADMINISTRATION SET Intl. Medical Consultants | FPA |
| Nov 3, 1993 | K930974 | DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK Intl. Medical Consultants | FPA |
| Nov 3, 1993 | K930927 | DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE Intl. Medical Consultants | FPA |
| Nov 3, 1993 | K925418 | ENERGIZED CONTAINER SYSTEM Abbott Laboratories | FPA |
| Oct 14, 1993 | K912069 | AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET 3M Avi, Inc. | FPA |
| Oct 12, 1993 | K930926 | DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE Intl. Medical Consultants | FPA |
| Oct 12, 1993 | K922115 | IVAC NEEDLELESS INJECTION VALVE Y | FPA |
| Sep 27, 1993 | K925645 | SELEC-3 Biomedix, Inc. | FPA |
| Sep 3, 1993 | K930751 | DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE Intl. Medical Consultants | FPA |
| Sep 3, 1993 | K930750 | DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER Intl. Medical Consultants | FPA |
| Sep 3, 1993 | K930410 | DURHAM; LUER LOCK EXTENSION SET Intl. Medical, Inc. | FPA |
| Sep 3, 1993 | K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET Intl. Medical, Inc. | FPA |
| Aug 28, 1993 | K925362 | SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET Baxter Healthcare Corp | FPA |
| Aug 16, 1993 | K925930 | MPC-150 MALE TO MALE LUER ADAPTER Molded Products, Inc. | FPA |
| Aug 16, 1993 | K925927 | MPC-1000 INJECTION CAP/PLUG Molded Products, Inc. | FPA |
| Aug 11, 1993 | K926119 | EXEL HUBER INFUSION SET ROTATING WING Exel Intl. | FPA |
| Aug 3, 1993 | K925430 | LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER Douglas Medical Products Corp. | FPA |
| Aug 3, 1993 | K925058 | BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET C.R. Bard, Inc. | FPA |
| Jul 30, 1993 | K930855 | REPLACEMENT CAP Douglas Medical Products Corp. | FPA |
| Jul 30, 1993 | K925228 | IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL Y | FPA |
| Jul 27, 1993 | K926184 | DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT Douglas Medical Products Corp. | FPA |
| Jul 27, 1993 | K925219 | IVION ADMIN SETS W/FLOW CLIPS Ivion Corp. | FPA |
| Jul 22, 1993 | K931813 | NEEDLESAFE HANDGUARD Adrian Anesthesia Systems, Inc. | FPA |
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