ClearanceBrief
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)
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Top companies in FMF

DateFirm and productCodeLinked 510(k)
Jun 26, 2026Mentor Texas LP
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Open, Classified
FMFK110771
Jun 13, 2026ARROW 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
FMFK781978
Apr 2, 2026Cardinal Health 200, LLC
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Open, Classified
FMFK851090
Mar 6, 2026Becton Dickinson & Company
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Open, Classified
FMFK980987
Jun 20, 2025Integra 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
FMFK082454
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.
Open, Classified
FMFK091315
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 15 CM, Box of 5.
Open, Classified
FMFK091315
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 8CM, Box of 5.
Open, Classified
FMFK091315
Jun 12, 2025BD 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
FMFNone listed
Jun 12, 2025BD 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
FMFK071108
Apr 21, 2025Medtronic MiniMed, Inc.
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Open, Classified
FMFK160629
K190487 +3
Sep 16, 2024Cypress 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
FMFNone listed
Sep 6, 2024Sol-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
FMFNone listed
Sep 6, 2024Sol-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
FMFNone listed
Sep 6, 2024Sol-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
FMFNone listed
Sep 6, 2024Sol-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
FMFNone listed
Sep 6, 2024Sol-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
FMFNone listed
Sep 6, 2024MEDLINE 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
FMFK103830
Aug 29, 2024Cypress 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
FMFK103830
Aug 8, 2024LINEAGE BIOMEDICAL, INC
NavaClick Syringe and Needle, Model Number LIN02
Open, Classified
FMFK231877
Jun 7, 2024Mckesson 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
FMFK131641
May 31, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Open, Classified
FMFK061275
May 31, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Open, Classified
FMFK061275
May 31, 2024MEDLINE 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed
May 20, 2024Jiangsu 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
FMFNone listed

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