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) |
|---|---|---|---|
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended f Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended fo Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for Terminated |
FMF | K102969 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for Terminated |
FMF | K102969 |
| Mar 23, 2017 | Merit Medical Systems, Inc. 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P. Terminated |
FMF | K875196 |
| Sep 16, 2016 | Becton Dickinson & Company BD 3ml Syringer Luer-Lok Tip
Catalog #309604
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection Terminated |
FMF | K110771 |
| Sep 16, 2016 | Becton Dickinson & Company BD 10mL Syringe Luer-Lok Tip Catalog number 301997
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection Terminated |
FMF | K110771 |
| Sep 16, 2016 | Becton Dickinson & Company BD 3ml Syringe Luer-Lok" Tip
Catalog 309657
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection Terminated |
FMF | K110771 |
| Sep 16, 2016 | Becton Dickinson & Company BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm)
Catalog #309580
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for gene Terminated |
FMF | K110771 |
| Sep 16, 2016 | Becton Dickinson & Company BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm)
Catalog #309571
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general Terminated |
FMF | K110771 |
| Sep 16, 2016 | Becton Dickinson & Company BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062 Terminated |
FMF | K110771 |
| May 25, 2016 | Biomet, Inc. PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression. Terminated |
FMF | K141762 |
| Mar 25, 2016 | Becton Dickinson & Company Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection Terminated |
FMF | K110771 |
| Mar 25, 2016 | Becton Dickinson & Company Henry Schein Single Use Syringe Luer-Lock, 10 mL,
Intended for use by health care professionals for general purpose fluid aspiration/injection Terminated |
FMF | K110771 |
| Jan 30, 2016 | Baxter Corporation Englewood Baxter, RAPIDFILL Syringe Strip, 10 ml.
For use with RAPIDFILL Automated Syringe Filler (ASF) Terminated |
FMF | K980181 |
| Oct 30, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Bone Marrow Biopsy Trays Catalogue No. 3404253
Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable p Terminated |
FMF | K960248 |
| Jul 15, 2015 | Owen Mumford USA, Inc. Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01,
The product is a non-sterile automatic subcutaneous injection device which delivers ins Terminated |
FMF | K983974 |
| Mar 11, 2015 | Medela Inc. EF Division - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile)
- NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile)
- TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile)
- INT-60 6 Terminated |
FMF | K092986 |
| Feb 5, 2015 | Becton Dickinson & Company BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348,
BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin Terminated |
FMF | K110771 K944931 +1 |
| May 14, 2014 | Baxter Corporation Englewood RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Terminated |
FMF | None listed |
| Apr 3, 2014 | Merit Medical Systems, Inc. Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO. Terminated |
FMF | K875196 |
| Oct 17, 2013 | Harvest Technologies Corporation Harvest Graft Delivery System; Model Number: GDP-10
Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. Th Terminated |
FMF | K043261 |
| Dec 19, 2012 | Becton Dickinson & Company Case Carton:
BD Oral Dispensing Syringe
1 mL Clear with Tip Cap
BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com
BD, Laagstraat 57, B-9140 Temse, Belgium
On 100 unit plastic bag:
BD oral sy Terminated |
FMF | K980987 |
| Oct 22, 2012 | Ethicon, Inc. EVICEL Fibrin Sealant (Human) Rx Only.
Manufacturer:
Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603.
Distributed Terminated |
FMF | K090162 |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 1/2mL 30 X 5/16"
Product ID: 8881511336
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | K922522 |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 1/2mL 29 X 1/2"
Product ID: 8881511136
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | K922522 |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 3/10mL 30 X 5/16"
Product ID: 8881511344
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | K922522 |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"
Product ID: 8881511144
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | K922522 |
| Sep 21, 2011 | Synthes USA (HQ), Inc. Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)
Indicated for aspirating bone marrow Terminated |
FMF | K051720 |
| Jun 22, 2011 | Integra LifeSciences Corp. Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119. Terminated |
FMF | K960248 |
| Jun 22, 2011 | Integra LifeSciences Corp. Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119. Terminated |
FMF | K960248 |
| Dec 2, 2010 | Merit Medical Systems, Inc. Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | K994253 |
| Dec 2, 2010 | Merit Medical Systems, Inc. Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | K994253 |
| Dec 2, 2010 | Merit Medical Systems, Inc. VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | K994253 |
| Dec 2, 2010 | Merit Medical Systems, Inc. VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | K994253 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 12ml, CAT No: CCS201E Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 10ml, CAT No: CCX011 Version A, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 10ml, CAT No: CCX010E Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 12ml, CAT No: CCS100 Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Oct 15, 2010 | Merit Medical Systems, Inc. Control Syringe, 12ml, CAT No: CCS600 Version B, Sterile R, Merit Medical Systems, Inc.
Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are Terminated |
FMF | K875196 |
| Mar 31, 2010 | Ulti Med, Inc. Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare.
Used to draw a quantity of pharmaceutical from its container and allow administratio Terminated |
FMF | K062702 |
| Mar 11, 2010 | Nipro Medical Corporation NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 331 Terminated |
FMF | None listed |
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