ClearanceBrief
Panels › General Hospital › Product code FMI · Class 2

Needle, Hypodermic, Single Lumen

Regulation 880.5570

13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
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Top companies in FMI

DateFirm and productCodeLinked 510(k)
Sep 16, 2026embecta Medical II LLC
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Open, Classified
FMIK213478
Sep 16, 2026embecta Medical II LLC
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Open, Classified
FMIK212015
Aug 14, 2026Bard Access Systems, Inc.
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit
Open, Classified
FMIK191976
K203193
Jul 17, 2025Waismed Ltd.
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access de
Open, Classified
FMIK211968
Jul 17, 2025Waismed Ltd.
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access
Open, Classified
FMIK142086
Jan 3, 2025Greiner Bio-One GmbH
VACUETTE SAFELINK, REF: 450210
Open, Classified
FMIK180545
Jul 23, 2024Embecta Corp.
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral admin
Open, Classified
FMIK212015
Mar 14, 2024Retractable Technologies, Inc.
EasyPoint Needle, 25G x 5/8", REF: 82091
Open, Classified
FMIK133635
Sep 29, 2023Apellis Pharmaceuticals, Inc.
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 m
Open, Classified
FMIK222681
Jul 22, 2022Bard Access Systems, Inc.
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Power
Open, Classified
FMIK191976
K203193
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Terminated
FMINone listed
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Terminated
FMINone listed
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
Terminated
FMINone listed
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
Terminated
FMINone listed
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Terminated
FMINone listed
Aug 24, 2021Zhejiang Kindly Medical Devices Co., Ltd.
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Terminated
FMINone listed
Jul 27, 2021Bard Peripheral Vascular Inc
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Open, Classified
FMIK930217
May 26, 2021Owen Mumford USA, Inc.
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Open, Classified
FMIK152339
Mar 16, 2021Cardinal Health Inc.
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Open, Classified
FMIK162516
Feb 9, 2021Cardinal Health 200, LLC
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface
Terminated
FMIK012736
Feb 9, 2021Cardinal Health 200, LLC
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product C
Terminated
FMINone listed
Feb 9, 2021Cardinal Health 200, LLC
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Pro
Terminated
FMINone listed
Nov 18, 2020Becton Dickinson & Company
BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface
Terminated
FMIK021475
Oct 23, 2020Becton Dickinson & Company
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Terminated
FMIK162516
Sep 25, 2020Cardinal Health 200, LLC
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patien
Terminated
FMIK854547
Jul 28, 2020Becton Dickinson & Company
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Terminated
FMIK951254
Jul 27, 2020C.A. Greiner & Sohne Gesellschaftmbh
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Open, Classified
FMINone listed
Jan 15, 2020Cardinal Health 200, LLC
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface
Terminated
FMIK123684
Jan 15, 2020Cardinal Health 200, LLC
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface
Terminated
FMIK123684
Oct 31, 2019Becton Dickinson & Company
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Terminated
FMIK982541
Oct 8, 2019Teleflex Medical
Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access
Open, Classified
FMIK141117
Oct 8, 2019Teleflex Medical
Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access
Open, Classified
FMIK141117
Oct 8, 2019Teleflex Medical
Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access
Open, Classified
FMIK141117
Jul 31, 2019Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blo
Terminated
FMIK011984
Apr 30, 2019Cardinal Health 200, LLC
Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Completed
FMIK854547
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle Item code: 8881200029
Completed
FMIK854547

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