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 |
|---|---|---|---|
| Oct 21, 2004 | K042693 | IV ADMINISTRATION SET B400 SP Codan US Corp. | FPA |
| Oct 7, 2004 | K042172 | CLEO 90 INFUSION SET Smiths Medical MD, Inc. | FPA |
| Oct 4, 2004 | K041919 | PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 Clinico, DE | FPA |
| Sep 17, 2004 | K040533 | EZ HUBER SAFETY INFUSION SET Pfm Medical, Inc. | FPA |
| Sep 8, 2004 | K042234 | MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET Specialty Health Products, Inc. | FPA |
| Sep 3, 2004 | K041844 | ALL SAFE HUBER SAFETY INFUSION SETS Nexus Medical, LLC | FPA |
| Sep 1, 2004 | K042182 | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Icu Medical, Inc. | FPA |
| Aug 24, 2004 | K041845 | NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 Nexus Medical, LLC | FPA |
| Aug 11, 2004 | K040710 | TEGO NEEDLE FREE ACCESS ACCESS DEVICE Icu Medical, Inc. | FPA |
| Jul 28, 2004 | K041410 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 Icu Medical, Inc. | FPA |
| Jul 16, 2004 | K041042 | SPLIT SEPTUM INJECTION SITES Fresenius Medical Care North America | FPA |
| Jun 30, 2004 | K041545 | CONTACT DETACH Unomedical A/S, DK | FPA |
| Jun 4, 2004 | K041179 | MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR Medegen Medical Manufacturing Services, Inc. | FPA |
| Jun 3, 2004 | K032767 | LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES Lily Medical Supplies Co., Ltd., TW | FPA |
| May 19, 2004 | K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc. | FPA |
| Apr 12, 2004 | K033290 | TALON INFUSION SET, MODEL IP XXXX Icu Medical, Inc. | FPA |
| Apr 7, 2004 | K040385 | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 Quest Medical, Inc. | FPA |
| Apr 1, 2004 | K040633 | CLICK-ON Unomedical A/S, DK | FPA |
| Mar 26, 2004 | K040527 | LOW PROFILE LUTHER SAFETY HUBER Luther Needlesafe Products, Inc. | FPA |
| Mar 18, 2004 | K033208 | IVY DEVICES INC. IV/MEDICAL LINE STABILIZER Ivy Devices, Inc., CA | FPA |
| Mar 9, 2004 | K033892 | ULTRAFLEX INFUSION SET Disetronic Medical Systems AG, SE | FPA |
| Mar 4, 2004 | K033301 | IV ADMINISTRATION AND CONNECT SETS Codan US Corp. | FPA |
| Jan 22, 2004 | K033515 | HUBERPRO SAFETY HUBER INFUSION SET Command Medical Products | FPA |
| Dec 4, 2003 | K033576 | LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE Abbott Laboratories | FPA |
| Dec 4, 2003 | K021692 | CLC2000 CATHETER PATENCY DEVICE Icu Medical, Inc. | FPA |
| Nov 18, 2003 | K033350 | BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER Becton, Dickinson & CO | FPA |
| Nov 13, 2003 | K032934 | MPS ACACIA SAFEGUARD HUBER DEVICE Mps Acacia | FPA |
| Oct 28, 2003 | K032485 | MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 Medtronic Minimed | FPA |
| Oct 28, 2003 | K032484 | MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 Medtronic Minimed | FPA |
| Oct 16, 2003 | K033099 | ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 Applied Diabetes Research, Incorporated | FPA |
| Oct 9, 2003 | K032854 | UNOMEDICAL MONICA INFUSION SET Unomedical A/S, DK | FPA |
| Sep 12, 2003 | K032150 | SAFETY-MULTIFLY Sarstedt, Inc. | FPA |
| Sep 8, 2003 | K021471 | MARQUETTE HUBER TRAP SAFETY INFUSION SET Marquette Medical, Inc. | FPA |
| Aug 29, 2003 | K020424 | V SET Hennig Enterprises Europe Srl, AU | FPA |
| Aug 29, 2003 | K020419 | V SET P.T. Greenleaf, AU | FPA |
| Aug 19, 2003 | K031917 | MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S Medtronic Minimed | FPA |
| Aug 11, 2003 | K031923 | ULTRASITE VALVE B.Braun Medical, Inc. | FPA |
| Jul 25, 2003 | K031500 | EXCEL PRIMARY SOLUTION SET Exelint Intl. Co. | FPA |
| Jul 1, 2003 | K031783 | SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 Intravascular Incorporated | FPA |
| Jul 1, 2003 | K023668 | JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR Jms North America Corp. | FPA |
| May 30, 2003 | K031279 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET Terumo Medical Products Hangzhou Co., Ltd. | FPA |
| May 30, 2003 | K031266 | SURSHIELD SAFETY WINGED INFUSION SET Terumo Corp. | FPA |
| May 23, 2003 | K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP Deltec, Inc. | FPA |
| Apr 15, 2003 | K030385 | IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR Kawasumi Laboratories America, Inc. | FPA |
| Mar 27, 2003 | K020189 | EXEL BUTTERFLY SCALP VEIN SET Exelint International, Co. | FPA |
| Mar 20, 2003 | K030149 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 Avail Medical Products, Inc. | FPA |
| Mar 14, 2003 | K030467 | GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET Iv Medical, Inc. | FPA |
| Feb 26, 2003 | K030246 | VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 Victus, Inc. | FPA |
| Feb 26, 2003 | K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FPA |
| Feb 19, 2003 | K030137 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 Avail Medical Products, Inc. | FPA |
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