ClearanceBrief
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)
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Top companies in FMF

DateFirm and productCodeLinked 510(k)
May 20, 2024Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 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/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
Open, Classified
FMFNone listed
May 20, 2024Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 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 3ML L/L Model/Catalog Number: 83084 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 3ML L/S Model/Catalog Number: 83083 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/L Model/Catalog Number: 83082 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/S Model/Catalog Number: 83081 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 60ML L/L Model/Catalog Number: 83080 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 60ML L/S Model/Catalog Number: 83079 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 30ML L/L Model/Catalog Number: 83078 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 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Open, Classified
FMFNone listed
Feb 2, 2024Cardinal Health 200, LLC
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 26, 2023Cardinal Health 200, LLC
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Open, Classified
FMFNone listed
Oct 13, 2023Cardinal Health 200, LLC
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Open, Classified
FMFNone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Open, Classified
FMFK050999
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Open, Classified
FMFK050999
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Open, Classified
FMFK050999
Sep 27, 2023B. Braun Medical, Inc.
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc,
Open, Classified
FMFK063280
Sep 27, 2023B. Braun Medical, Inc.
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565
Open, Classified
FMFK063280
Sep 27, 2023Wolf, Henke Sass, Gmbh
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an ad
Open, Classified
FMFK821537
Mar 10, 2023Becton Dickinson & Company
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number:
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 3
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Numbe
Open, Classified
FMFK190054
Mar 10, 2023Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
Open, Classified
FMFK190054
Jan 11, 2023Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Open, Classified
FMFK102969
Jan 11, 2023Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Open, Classified
FMFK102969
Dec 13, 2022Allison Medical, Inc.
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Completed
FMFK132553
Nov 18, 2022Allison Medical, Inc.
InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Completed
FMFK191531
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
Open, Classified
FMFK760392
Oct 20, 2021MICROVENTION INC.
Aspiration Syringe Kit, REF: MVSK60
Terminated
FMFK994253
Dec 23, 2020Becton Dickinson & Company
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Terminated
FMFK980987
Aug 31, 2020ICU Medical, Inc.
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Open, Classified
FMFK080989
May 14, 2020Access Scientific LLC
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood a
Terminated
FMFNone listed

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