Panels › General Hospital › Product code FMF · Class 2
Syringe, Piston
Regulation 880.5860
14510(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 26, 2026 | Mentor Texas LP SYRINGE LUER LOK 10CC-200/BOX
BD Product Code: 302995
Mentor Product Code: B9604
Syringe, Piston Open, Classified |
FMF | K110771 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC KIT: 16 GA X 8IN/AK-04210,
CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300,
CVC KIT: 14 GA X 6 IN/CK-04711 Open, Classified |
FMF | K781978 |
| Apr 2, 2026 | Cardinal Health 200, LLC Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 Open, Classified |
FMF | K851090 |
| Mar 6, 2026 | Becton Dickinson & Company 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. Open, Classified |
FMF | K980987 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids. Open, Classified |
FMF | K082454 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator 8CM, Box of 1. Open, Classified |
FMF | K091315 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 15 CM, Box of 5. Open, Classified |
FMF | K091315 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 8CM, Box of 5. Open, Classified |
FMF | K091315 |
| Jun 12, 2025 | BD SWITZERLAND SARL BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006 Open, Classified |
FMF | None listed |
| Jun 12, 2025 | BD SWITZERLAND SARL BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060 Open, Classified |
FMF | K071108 |
| Apr 21, 2025 | Medtronic MiniMed, Inc. InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA Open, Classified |
FMF | K160629 K190487 +3 |
| Sep 16, 2024 | Cypress Medical Products LLC General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Low Dead Space labeled as:
a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;
b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Eccentric Tips labeled as:
1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551;
2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, U Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Luer Slip Tips labeled as:
1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138;
2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523 Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with exchangeable needles labeled as:
SOL-CARE:
1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858;
2) SOL-CARE 10ml Luer L Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Fixed Needles labeled as:
a) SOL-M:
1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884;
2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/ Open, Classified |
FMF | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ;
2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ;
3) SYRINGE KIT , Pack Number NAM000 Open, Classified |
FMF | K103830 |
| Aug 29, 2024 | Cypress Medical Products LLC McKesson Syringe 60CC, Luer Lock Tip, Sterile,
ITEM NO 102-S60C.
Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS) Open, Classified |
FMF | K103830 |
| Aug 8, 2024 | LINEAGE BIOMEDICAL, INC NavaClick Syringe and Needle, Model Number LIN02 Open, Classified |
FMF | K231877 |
| Jun 7, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body
MMS Catalog Number: 1159851
Cardinal Catalog Number: 8881560125 Completed |
FMF | K131641 |
| May 31, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 Open, Classified |
FMF | K061275 |
| May 31, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 Open, Classified |
FMF | K061275 |
| May 31, 2024 | MEDLINE INDUSTRIES, LP - Northfield Syringes labeled as:
a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10;
b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B;
c) SYRINGE 20ML RED L/L LOW PRESS, Item N Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: MEDLINE
Product Name: SYR 20ML/L PURPLE
Model/Catalog Number: 91843
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: MEDLINE
Product Name: SYR 10ML/L BLUE CONTRAST
Model/Catalog Number: 91848
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: MEDLINE
Product Name: SYR 20ML/L WHITE HEP FLUSH
Model/Catalog Number: 91862
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: MEDLINE
Product Name: SYR 20ML/L WHITE CONTRAST
Model/Catalog Number: 91860
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 5ML/LL syringe
Model/Catalog Number: TS2205S-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 60ML/LL Blue syringe
Model/Catalog Number: TS2260LB-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 10ML/LL Blue syringe
Model/Catalog Number: TS2210B-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 10ML Control syringe
Model/Catalog Number: TS3210L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 60ML/LS syringe
Model/Catalog Number: TS2260S-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 20ML/LS syringe
Model/Catalog Number: TS2220S-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 12ML/LS syringe
Model/Catalog Number: TS2212S-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 10ML/LS syringe
Model/Catalog Number: TS2210S-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 60ML/LL syringe
Model/Catalog Number: TS2260L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 35ML/LL syringe
Model/Catalog Number: TS2235L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 30ML/LL syringe
Model/Catalog Number: TS2230L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 20ML/LL syringe
Model/Catalog Number: TS2220L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 12ML/LL syringe
Model/Catalog Number: TS2212L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 10ML/LL syringe
Model/Catalog Number: TS2210L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 6ML/LL syringe
Model/Catalog Number: TS2206L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 5ML/LL syringe
Model/Catalog Number: TS2205L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: GMAX
Product Name: SYR 3ML/LL syringe
Model/Catalog Number: TS2203L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: Wolf Medical
Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC
Model/Catalog Number: SYR60L
Product Description: NON-Sterile syringes without needles for single use
Compo Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: Wolf Medical
Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC
Model/Catalog Number: SYR35L
Product Description: NON-Sterile syringes without needles for single use
Compo Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: Wolf Medical
Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC
Model/Catalog Number: SYR20L
Product Description: NON-Sterile syringes without needles for single use
Compo Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: Wolf Medical
Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC
Model/Catalog Number: SYR12L
Product Description: NON-Sterile syringes without needles for single use
Compo Open, Classified |
FMF | None listed |
| May 20, 2024 | Jiangsu Shenli Medical Production Co., Ltd. Brand Name: Wolf Medical
Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC
Model/Catalog Number: SYR06L
Product Description: NON-Sterile syringes without needles for single use
Compon Open, Classified |
FMF | None listed |
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