Needle, Hypodermic, Single Lumen

FDA product code FMI · 670 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5570
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-16 – 2026-09-17

FMI 2019-10-07

NIO-I

Applicant Waismed, Ltd.

K number K190538

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FMI 2019-09-05

Dual-Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K number K191853

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FMI 2019-05-07

SteriCap Mini Needle

Applicant Ocujet, LLC

K number K183016

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FMI 2019-04-09

Adult Intraosseous Infusion Device

Applicant Einstein Works, LLC

K number K182770

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FMI 2019-03-12

Safety insulin needle for single use

Applicant Berpu Medical Technology Co., Ltd.

K number K181447

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FMI 2019-03-01

BD Vacutainer Eclipse UltraFill Blood Collection Needle

Applicant Becton, Dickinson and Company

K number K181730

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FMI 2019-02-13

U&U Blood Collection Sets

Applicant U&U Medical Technology Co, Ltd.

K number K181508

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FMI 2018-12-20

BD Contoured Base Pen Needle

Applicant Becton, Dickinson and Company

K number K182320

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FMI 2018-12-03

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

Applicant Sol-Millennium Medical, Inc.

K number K182146

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FMI 2018-11-13

Immucise Intradermal Injection System

Applicant Terumo Corporation

K number K181369

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FMI 2018-11-09

EZ-IO Intraosseous Vascular Access System

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K number K180395

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FMI 2018-08-28

Disposable Insulin Pen Needle

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K number K181069

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FMI 2018-08-20

BD Vacutainer Eclipse Signal Blood Collection Needle

Applicant Becton, Dickinson and Company

K number K170824

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FMI 2018-08-03

EasyTouch Safety Pen Needle

Applicant Mhc Medical Products, LLC

K number K163578

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FMI 2018-07-24

Autokeeper

Applicant Medexel Co.,Ltd

K number K172095

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FMI 2018-07-11

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G

Applicant Owen Mumford, Ltd.

K number K173881

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FMI 2018-06-27

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

Applicant Medibio USA, LLC

K number K180720

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FMI 2018-06-21

Kopac Sterile Needle

Applicant Poonglim Pharmatech, Inc.

K number K172483

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FMI 2018-06-14

Disposable Sterile Needle

Applicant Jiangsu Caina Medical Co.,Ltd

K number K172938

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FMI 2018-06-11

Omnican fine

Applicant B.Braun Medical, Inc.

K number K173803

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FMI 2018-05-21

VACUETTE SAFELINK Holder with male luer lock

Applicant Greiner Bio-One Na, Inc.

K number K180545

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FMI 2018-05-18

Sterile Hypodermic Needle for Single Use

Applicant Jiangsu Shenli Medical Production Co., Ltd.

K number K180259

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FMI 2018-05-14

RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

Applicant Myco Medical Supplies, Inc.

K number K173279

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FMI 2018-04-19

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

Applicant Greiner Bio-One Na, Inc.

K number K173757

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FMI 2018-04-17

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

Applicant Teleflex Medical

K number K180588

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FMI 2018-03-21

DROPLET PEN NEEDLE

Applicant Htl-Strefa S.A

K number K171982

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FMI 2018-01-17

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)

Applicant Novo Nordisk, Inc.

K number K173479

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FMI 2017-12-12

DropSafe Safety Pen Needle

Applicant Htl-Strefa S.A

K number K170988

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FMI 2017-12-11

Safety Blood Collection Device for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K number K170276

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FMI 2017-10-11

Clickfine Pen Needle, Penfine Classic Pen Needle

Applicant Ypsomed AG

K number K171984

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FMI 2017-09-12

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel

Applicant Medbio, LLC

K number K171144

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FMI 2017-07-10

Mini Needle

Applicant Ocuject, LLC

K number K170768

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FMI 2017-05-11

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K number K161950

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FMI 2017-03-14

Safety Blood Collection Set

Applicant Jiangsu Shenli Medical Production Co., Ltd.

K number K163093

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FMI 2017-01-19

meso-relle (AAL34, AAL36, AM30G)

Applicant Biotekne Srl

K number K161255

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FMI 2016-12-09

BD Pen Needle

Applicant Becton, Dickinson and Company

K number K162516

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FMI 2016-11-03

Greiner Holdex

Applicant Greiner Bio-One Na, Inc.

K number K160532

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FMI 2016-10-19

Advocate Insulin Pen Needles

Applicant Diabetic Supply of Suncoast, Inc.

K number K160199

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FMI 2016-09-21

CPL Insulin Pen Needle

Applicant Cpl Co., Ltd.

K number K151090

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FMI 2016-09-07

CareSens Pen Needle, Softip Pen Needle

Applicant Yidobio, Inc.

K number K160575

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FMI 2016-08-29

Insulin Pen Needle

Applicant SteriLance Medical (Suzhou), Inc.

K number K153706

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FMI 2016-07-26

Cook Intraosseous Infusion Needles

Applicant Cook Incorporated

K number K160887

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FMI 2016-07-11

JSM Insulin Pen Needle

Applicant Jeesung Medical Co., Ltd.

K number K152166

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FMI 2016-07-06

BD SafeAssist

Applicant Becton, Dickinson and Company

K number K161553

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FMI 2016-06-24

Unifine Pentips/ Unifine Pentips Plus

Applicant Owen Mumford, Ltd.

K number K152339

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FMI 2016-06-23

NIO-P

Applicant Waismed, Ltd.

K number K160805

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FMI 2016-06-08

ProteXsure Safety Capsule System

Applicant Starcap Medical, LLC ( Dba Prism Medical & Design)

K number K152597

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FMI 2016-06-07

IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle

Applicant Guangzhou Improve Medical Instruments Co., Ltd.

K number K153388

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FMI 2016-06-07

SureFine Pen Needle

Applicant Shina Med Corporation

K number K152877

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FMI 2016-05-27

BD Eclipse Hypodermic Needle

Applicant Becton, Dickinson and Company

K number K161170

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FMI 2016-03-17

Sungshim Insulin Pen Needle

Applicant Sung Shim Medicare Co., Ltd.

K number K152334

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FMI 2016-03-07

MEDT PEN NEEDLE

Applicant Shandong Caremed Medical Products Co., Ltd.

K number K152824

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FMI 2016-03-02

Pencylcap

Applicant B.Braun Melsungen AG

K number K152050

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FMI 2016-02-10

Safe Block Pen Needle

Applicant Artsana S.P.A

K number K151311

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FMI 2016-02-02

Top Fine Pen Needle

Applicant Medexel Co.,Ltd

K number K152410

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FMI 2013-11-20

SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE

Applicant Wuxi Yushou Medical Applicances Co., Ltd.

K number K130212

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FMI 2013-11-13

U&U STERILE HYPODERMIC NEEDLE

Applicant U&U Medical Technology Co, Ltd.

K number K132552

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FMI 2013-09-06

K-PACK II NEEDLE - 27G X 3/4 THIN WALL

Applicant Terumo Europe N.V.

K number K132233

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FMI 2013-08-20

STERICAN CANNULA

Applicant B.Braun Medical, Inc.

K number K131842

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FMI 2013-07-16

BD PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K131358

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FMI 2013-07-15

EXTAVIPRO STERICAN 30G

Applicant B.Braun Melsungen AG

K number K131040

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FMI 2013-07-05

CLICKFINE PEN NEEDLE

Applicant Ypsomed AG

K number K131125

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FMI 2013-07-05

CLICKFINE AUTOPROTECT PEN NEEDLE

Applicant Ypsomed AG

K number K131123

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FMI 2013-06-25

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

Applicant Pyng Medical Corp.

K number K130487

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FMI 2013-05-08

SOL-CARE SAFETY NEEDLE

Applicant Sol-Millennium Medical

K number K123684

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FMI 2013-01-18

BD PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K123300

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FMI 2012-11-08

TERUMO(R) NEEDLE

Applicant Terumo (Philippines) Corporation

K number K121607

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FMI 2012-10-25

CLICKFINE PEN NEEDLE

Applicant P/L Biomedical

K number K122971

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FMI 2012-10-25

CLICKFINE PEN NEEDLE

Applicant P/L Biomedical

K number K122969

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FMI 2012-10-18

STERILE BLUNT FOR SINGLE USE

Applicant Shanghai Double Dove Industrial Co., Ltd.

K number K120420

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FMI 2012-10-18

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

Applicant Nipro Medical Corporation

K number K113469

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FMI 2012-08-28

TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE

Applicant Terumo (Philippines) Corporation

K number K122249

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FMI 2012-08-10

COMFORT EZ

Applicant Simple Diagnostics, Inc.

K number K121632

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FMI 2012-07-25

SAFETY INFUSION SET

Applicant Greiner Bio-One North America, Inc.

K number K121908

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FMI 2012-06-22

INSULIN PEN NEEDLE

Applicant Tiger Medical Products, Ltd.

K number K120690

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FMI 2012-06-03

THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE

Applicant Vidacare Corporation

K number K120661

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FMI 2012-05-23

PUSH-ON NEEDLE 30GX8MM

Applicant Scandinavian Health Limited

K number K120191

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FMI 2012-04-12

STERILE INSULIN PEN NEEDLE

Applicant Shina Corp.

K number K113186

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FMI 2012-03-05

TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE

Applicant Terumo (Philippines) Corporation

K number K113422

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FMI 2012-02-24

SOL-M EXCHANGEABLE NEEDLES

Applicant Sol-Milennium Medical, Inc.

K number K112777

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FMI 2012-02-17

VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER

Applicant Greiner Bio-One North America, Inc.

K number K113505

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FMI 2012-01-26

CLICKFINE AUTOPROTECT PEN NEEDLE

Applicant Ypsomed AG

K number K110312

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FMI 2012-01-10

FINE JECT INSULIN PEN NEEDLE

Applicant Twobiens Co., Ltd.

K number K112332

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FMI 2011-12-23

EASY TOUCH

Applicant Mhc Medical Products, LLC

K number K112789

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FMI 2011-09-29

MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE

Applicant M.V.S.R.L.

K number K110606

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FMI 2011-09-22

27 G X 1/2 K-PACK SURSHIELD NEEDLE

Applicant Terumo Europe N.V.

K number K111797

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FMI 2011-08-18

IMC BLOOD COLLECTION NEEDLE

Applicant International Medsurg Connection

K number K110656

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FMI 2011-07-29

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH

Applicant Medpro Safety Products, Inc.

K number K111424

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FMI 2011-07-27

BD AUTOSHIELD DUO PEN NEEDLE

Applicant Becton, Dickinson and Company

K number K110703

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FMI 2011-06-09

K-PACK II NEEDLE- 27G & 30G THIN WALL

Applicant Terumo Europe N.V.

K number K110850

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FMI 2011-06-06

K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE

Applicant Terumo Europe N.V.

K number K110527

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FMI 2011-05-13

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K number K102328

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FMI 2011-04-28

BD PEN NEEDLE

Applicant Becton, Dickinson and Company (BD)

K number K110105

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FMI 2011-04-06

DISPOSABLE BLLOD COLLECTION NEEDLE

Applicant Weihai Hongyu Medical Devices Co., Ltd.

K number K103587

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FMI 2011-01-14

IMC HYPODERMIC NEEDLE

Applicant International Medsurg Connection

K number K102584

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FMI 2010-11-23

CLICKFINE PEN NEEDLE

Applicant Ypsomed AG

K number K102108

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FMI 2010-11-19

VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET

Applicant Medpro Safety Products, Inc.

K number K102010

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FMI 2010-11-03

K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

Applicant Kawasumi Laboratories, Inc.

K number K102994

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FMI 2010-10-15

VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER

Applicant Greiner Bio-One North America, Inc.

K number K102774

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FMI 2010-08-31

FASTX STERNAL INTRAOSSEOUS DEVICE

Applicant Pyng Medical Corp.

K number K100124

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