Panels › General Hospital › Product code FMF · Class 2
Syringe, Piston
Regulation 880.5860
13510(k)s in 12 months (752 all time)
4recalls in 12 months (305 all time)
168recalls that name a 510(k)
Top companies in FMF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2009 | Becton Dickinson & Company BD 30 ml Syringe;
Luer-Lok Tip
Catalog # 309650
Becton Dickinson, Franklin Lakes, NJ. Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-21 Terminated |
FMF | K021197 K080904 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7001-21 Terminated |
FMF | K021197 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21 Terminated |
FMF | K021197 K080904 +1 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21 Terminated |
FMF | K021197 K080904 +1 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21 Terminated |
FMF | K021197 K080904 +1 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21 Terminated |
FMF | K021197 K080904 +1 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21 Terminated |
FMF | K021197 K080904 +1 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to be used as an insulin Terminated |
FMF | K021197 K080904 +1 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology procedures. Terminated |
FMF | K875196 |
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr Terminated |
FMF | K071459 |
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr
Used to provide an optional filling device for the Easypump. Terminated |
FMF | K071459 |
| Sep 24, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton Terminated |
FMF | K021197 |
| Sep 24, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton Terminated |
FMF | K021197 |
| Aug 12, 2009 | Becton Dickinson & Company BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA. Terminated |
FMF | None listed |
| Jun 24, 2009 | Becton Dickinson & Company BD 20 ml Syringe
Luer-Lok Tip
Sterile, Do not reuse; Catalog Number 309661. Terminated |
FMF | None listed |
| Jun 24, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2 Terminated |
FMF | K070917 |
| Sep 21, 2008 | Merit Medical Systems, Inc. 12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Perip Terminated |
FMF | K875196 |
| Sep 21, 2008 | Merit Medical Systems, Inc. 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Periphe Terminated |
FMF | K875196 |
| Sep 21, 2008 | Merit Medical Systems, Inc. 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Periph Terminated |
FMF | K875196 |
| Sep 20, 2008 | Smith & Nephew Inc Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116 Terminated |
FMF | K041976 |
| Sep 20, 2008 | Smith & Nephew Inc Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116. Terminated |
FMF | K041976 |
| Sep 18, 2008 | Becton Dickinson & Company BD 60 ml Syringe, Luer-Lok Tip
Sterile;
Cases : 160 (4 x 40)
Shelf Carton: 40
BD; Franklin Lakes, NJ 07417 USA. Made in USA.
Syringes for use in aspiration and injection of medications. Terminated |
FMF | None listed |
| Aug 14, 2008 | Integra Pain Management Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791 Terminated |
FMF | K960248 |
| Apr 16, 2008 | Becton Dickinson & Company BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417. Terminated |
FMF | None listed |
| Apr 16, 2008 | Becton Dickinson & Company BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417. Terminated |
FMF | None listed |
| Nov 24, 2007 | Baxter Bioscience Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FMF | K020666 |
| Jul 4, 2007 | Biomet, Inc. Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States). Terminated |
FMF | None listed |
| Jul 4, 2007 | Biomet, Inc. Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300. Terminated |
FMF | K021071 |
| May 24, 2007 | Becton Dickinson & Company BD 5ml Syringe Luer-Lok Tip
Bulk Sterile Convenience Pak
Latex Free Terminated |
FMF | K980987 |
| Apr 5, 2007 | Becton Dickinson & Company BD 30ml Syringe Luer-Lok tip
Sterile
BD, Franklin Lakes, NJ
Made in USA Terminated |
FMF | K980987 |
| Mar 3, 2007 | Becton Dickinson & Company BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle
1 ml 29g 1/2'' (0.33mm x 13 mm)
Re-Order No. 305282
U-100 insulin
Lot 6073436 Terminated |
FMF | K023752 |
| Oct 21, 2006 | Kendall a Division of Tyco Healthcare Group LP Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744 Terminated |
FMF | K852544 |
| Jan 18, 2006 | Becton Dickinson & Company BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide. Terminated |
FMF | K992734 |
| Jan 18, 2006 | Becton Dickinson & Company BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle. Terminated |
FMF | K992734 |
| Jan 18, 2006 | CooperSurgical, Inc. Milex 60cc Handy-Vak Locking Syringe
Ref: MX500 Terminated |
FMF | None listed |
| Jul 28, 2005 | Becton Dickinson & Company #309604 -- 10 mL syringe Terminated |
FMF | K980987 |
| Jul 28, 2005 | Becton Dickinson & Company #309644 -- 10 ml syringe with 20 G1'' Needle Terminated |
FMF | K980987 |
| Jul 28, 2005 | Becton Dickinson & Company #309661 -- Syringe only ll 20 mL Terminated |
FMF | K980987 |
| Jul 28, 2005 | Becton Dickinson & Company # 309604 -- Syringe 10 mL LL Terminated |
FMF | K980987 |
| Jul 28, 2005 | Becton Dickinson & Company # 309603 -- Syringe 5Ml LL syringe. Terminated |
FMF | K980987 |
| Jul 28, 2005 | Becton Dickinson & Company BD Syringes -
#309585 -- Piston Syringe, Syringe 3ML LL Syringe. Terminated |
FMF | None listed |
| Jun 30, 2005 | Qualitest Pharmaceuticals Inc AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21. Terminated |
FMF | None listed |
| Mar 3, 2005 | Becton Dickinson & Company ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23. Terminated |
FMF | K955235 |
| Oct 28, 2004 | Merit Medical Systems, Inc 10 ml Inject 10 Palm Pad, sterile Terminated |
FMF | K875196 |
| Sep 30, 2004 | Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, Terminated |
FMF | K030032 |
| Nov 19, 2003 | Merit Medical Systems, Inc VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160. Terminated |
FMF | K994253 |
| Oct 15, 2003 | Liberty Medical Supplies Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes Terminated |
FMF | K002921 |
| Oct 15, 2003 | Liberty Medical Supplies Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes Terminated |
FMF | K002921 |
| Oct 15, 2003 | Liberty Medical Supplies Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes Terminated |
FMF | K002921 |
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