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)
Top companies in FMI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | embecta Medical II LLC EWO_02513 (Catalog number 320122)
For Investigational Use Only
Nano Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K213478 |
| Sep 16, 2026 | embecta Medical II LLC EWO_02512 (Catalog number 320550)
For Investigational Use Only
Nano Pro Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K212015 |
| Aug 14, 2026 | Bard 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 |
FMI | K191976 K203193 |
| Jul 17, 2025 | Waismed 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 |
FMI | K211968 |
| Jul 17, 2025 | Waismed 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 |
FMI | K142086 |
| Jan 3, 2025 | Greiner Bio-One GmbH VACUETTE SAFELINK, REF: 450210 Open, Classified |
FMI | K180545 |
| Jul 23, 2024 | Embecta 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 |
FMI | K212015 |
| Mar 14, 2024 | Retractable Technologies, Inc. EasyPoint Needle, 25G x 5/8", REF: 82091 Open, Classified |
FMI | K133635 |
| Sep 29, 2023 | Apellis 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 |
FMI | K222681 |
| Jul 22, 2022 | Bard 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 |
FMI | K191976 K203193 |
| Aug 24, 2021 | Zhejiang 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 |
FMI | None listed |
| Aug 24, 2021 | Zhejiang 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 |
FMI | None listed |
| Aug 24, 2021 | Zhejiang Kindly Medical Devices Co., Ltd. McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS Terminated |
FMI | None listed |
| Aug 24, 2021 | Zhejiang Kindly Medical Devices Co., Ltd. McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS Terminated |
FMI | None listed |
| Aug 24, 2021 | Zhejiang Kindly Medical Devices Co., Ltd. McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS Terminated |
FMI | None listed |
| Aug 24, 2021 | Zhejiang Kindly Medical Devices Co., Ltd. McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS Terminated |
FMI | None listed |
| Jul 27, 2021 | Bard 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 |
FMI | K930217 |
| May 26, 2021 | Owen Mumford USA, Inc. Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. Open, Classified |
FMI | K152339 |
| Mar 16, 2021 | Cardinal Health Inc. BD UF PEN 32GX4MM 100 NANO
Item Number: 4292272 Open, Classified |
FMI | K162516 |
| Feb 9, 2021 | Cardinal 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 |
FMI | K012736 |
| Feb 9, 2021 | Cardinal 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 |
FMI | None listed |
| Feb 9, 2021 | Cardinal 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 |
FMI | None listed |
| Nov 18, 2020 | Becton 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 |
FMI | K021475 |
| Oct 23, 2020 | Becton 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 |
FMI | K162516 |
| Sep 25, 2020 | Cardinal 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 |
FMI | K854547 |
| Jul 28, 2020 | Becton Dickinson & Company BD SafetyGlideTM 3ml 25G x 1
3mL SafetyGlide syringes, 50 units in pack Terminated |
FMI | K951254 |
| Jul 27, 2020 | C.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 |
FMI | None listed |
| Jan 15, 2020 | Cardinal 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 |
FMI | K123684 |
| Jan 15, 2020 | Cardinal 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 |
FMI | K123684 |
| Oct 31, 2019 | Becton Dickinson & Company BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 Terminated |
FMI | K982541 |
| Oct 8, 2019 | Teleflex 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 |
FMI | K141117 |
| Oct 8, 2019 | Teleflex 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 |
FMI | K141117 |
| Oct 8, 2019 | Teleflex 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 |
FMI | K141117 |
| Jul 31, 2019 | Becton 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 |
FMI | K011984 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm)
Item code: 8881202389 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm)
Item code: 8881202363 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm)
Item code: 8881202355 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm)
Item code: 8881202322 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm)
Item code: 8881202314 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2
Item code: 8881201654 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2
Item code: 8881201548 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2
Item code: 8881201522 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2"
Item code: 8881201498 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2"
Item code: 8881201456 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk
Item code: 8881200664 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 27 G x 1-1/4"
Item code: 8881200508 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 18 G x 1-1/2"
Item code: 8881200078 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 16 G x 1-1/2"
Item code:8881200045 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 16 G x 1-1/2"
Item code: 8881200037 Completed |
FMI | K854547 |
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle
Item code: 8881200029 Completed |
FMI | K854547 |
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