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 2010-08-20

ZIRCONIA SYRINGE NEEDLE

Applicant Kuo Tai Hospital Managements & Consultant Co., Ltd.

K number K093043

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FMI 2010-07-27

POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO

Applicant Vidacare Corporation

K number K101026

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FMI 2010-06-18

NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')

Applicant Novo Nordisk, Inc.

K number K093109

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FMI 2010-06-03

ULTICARE DISPOSABLE PEN NEEDLES

Applicant Ultimed, Inc.

K number K100812

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FMI 2010-04-30

CLICKFINE PEN NEEDLE

Applicant Ypsomed AG

K number K100436

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FMI 2010-04-15

BD PEN NEEDLE

Applicant Becton, Dickinson and Co.

K number K100005

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FMI 2010-02-19

BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY

Applicant Becton, Dickinson & CO

K number K100209

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FMI 2010-02-03

MICRONJET 600

Applicant Nanopass Technologies , Ltd.

K number K092746

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FMI 2010-02-01

FLEXPEN NEEDLE

Applicant Novo Nordisk, Inc.

K number K090111

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FMI 2010-01-14

DISPOSABLE HYPODERMIC NEEDLE

Applicant Feel Tech

K number K092831

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FMI 2009-10-14

EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO

Applicant Vidacare Corporation

K number K091140

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FMI 2009-10-02

SUPER-FINE PEN NEEDLE

Applicant Stat Medical Devices, Inc.

K number K092016

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FMI 2009-09-29

AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

Applicant Autosafe-Reflex, Inc.

K number K090117

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FMI 2009-09-01

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000

Applicant Wcm Waste & Compliance Management, Inc.

K number K090156

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FMI 2009-06-12

VAKU-8 BLOOD COLLECTION NEEDLES

Applicant Myco Medical Supplies, Inc.

K number K090426

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FMI 2009-04-24

NOVAGUARD, MODEL 3611001

Applicant West Pharmaceutical Services, Inc.

K number K082908

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FMI 2009-01-16

MEDIGARD BLOOD COLLECTION DEVICE

Applicant Medigard Limited

K number K082511

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FMI 2008-10-23

K-PACK II NEEDLE - 29G THIN WALL

Applicant Terumo Europe N.V.

K number K082820

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FMI 2008-06-18

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM

Applicant Medpro Safety Products, Inc.

K number K072602

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FMI 2008-06-04

FEEL-FINE INSULIN PEN NEEDLE

Applicant Feel Tech

K number K080904

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FMI 2008-04-24

FAST1 INTRAOSSEOUS INFUSION SYSTEM

Applicant Pyng Medical Corp.

K number K080865

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FMI 2008-04-24

SAFETY INFUSION SET

Applicant Greiner Bio-One Vacuette North America

K number K080235

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FMI 2008-03-24

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE

Applicant Shandong Qiaopai Group Co., Ltd.

K number K073705

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FMI 2008-02-13

FAST1 INTRAOSSEOUS INFUSION SYSTEM

Applicant Pyng Medical Corp.

K number K072487

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FMI 2008-02-12

INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003

Applicant Inviro Medical Devices, Inc.

K number K071307

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FMI 2008-02-08

HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE

Applicant Smiths Medical Asd, Inc.

K number K073188

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FMI 2008-01-25

KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR

Applicant Kawasumi Laboratories, Inc.

K number K073257

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FMI 2007-12-20

BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K number K073127

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FMI 2007-11-21

MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE

Applicant Covidien Lp, Formerly Registered AS Tyco Healthcar

K number K073122

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FMI 2007-11-08

STERICAN HYPODERMIC NEEDLES

Applicant B.Braun Medical, Inc.

K number K072247

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FMI 2007-11-01

GRIPPER MICRO NEEDLE

Applicant Smiths Medical MD, Inc.

K number K072059

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FMI 2007-10-12

VACU-MED BLOOD COLLECTION NEEDLES

Applicant Shina Corp.

K number K071947

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FMI 2007-09-26

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT

Applicant Arrow Intl., Inc.

K number K071998

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FMI 2007-09-14

GREINER VACUETTE QUICKSHIELD COMPLETE

Applicant Greiner Bio-One North America, Inc.

K number K072320

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FMI 2007-09-14

AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE

Applicant Autosafe-Refelx, Inc.

K number K071567

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FMI 2007-08-23

SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)

Applicant Shinchang Medical Co., Ltd.

K number K070988

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FMI 2007-08-02

HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE

Applicant Smiths Medical Asd, Inc.

K number K071785

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FMI 2007-07-05

LIFE LATCH SHARPS & BIOHAZARD CONTAINER

Applicant M&M Industries, Inc.

K number K071088

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FMI 2007-03-16

BD HYPOINT NEEDLE

Applicant Becton, Dickinson & CO

K number K070440

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FMI 2007-03-02

TOP FINE

Applicant Daejin Tech Medical Manufacturing Co., Ltd.

K number K063466

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FMI 2007-01-26

EZ-MIO STERNAL

Applicant Vidacare Corporation

K number K063567

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FMI 2007-01-25

PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110

Applicant Smiths Medical Asd, Inc.

K number K063450

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FMI 2006-12-22

BONE INJECTION GUN (B.I.G.)

Applicant Waismed, Ltd.

K number K062940

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FMI 2006-12-08

MANUAL PD-IO; POWERED PD-IO

Applicant Vidacare Corporation

K number K063142

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FMI 2006-12-05

EZ-MIO, EZ-IO DISTAL TIBIA

Applicant Vidacare Corporation

K number K062956

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FMI 2006-11-21

FLEXPEN NEEDLE

Applicant Novo Nordisk, Inc.

K number K062500

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FMI 2006-11-16

HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER

Applicant Hager Worldwide, Inc.

K number K061933

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FMI 2006-11-13

MEDLINE HYPODERMIC NEEDLES

Applicant Medline Industries, Inc.

K number K062984

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FMI 2006-11-07

HUMERAL HEAD, MANUAL DRIVER

Applicant Vidacare Corporation

K number K062422

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FMI 2006-09-15

29G AND 30G K-PACK II NEEDLE

Applicant Terumo Europe N.V.

K number K062608

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FMI 2006-08-14

VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES

Applicant Greiner Bio-One North America, Inc.

K number K061483

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FMI 2006-06-21

DEPOTONE

Applicant Imprint Pharmaceuticals Limited

K number K061032

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FMI 2006-04-17

BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE

Applicant Busse Hospital Disposables, Inc.

K number K052843

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FMI 2006-03-23

BD AUTOSHIELD PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K060007

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FMI 2005-12-28

PROTECTOR NEEDLE SHEATH PROP

Applicant Certol International, LLC

K number K052725

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FMI 2005-12-21

NOVOFINE 32G TIP

Applicant Novo Nordisk, Inc.

K number K053470

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FMI 2005-12-05

DUOPROSS NEEDLE

Applicant Duopross Meditech Corporation

K number K052445

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FMI 2005-11-23

TERUMO MICRO TAPERED PEN NEEDLE

Applicant Kofu Factory of Terumo Corp.

K number K052561

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FMI 2005-11-17

EZ-IO

Applicant Vidacare Corporation

K number K052408

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FMI 2005-11-10

NIPRO HYPODERMIC NEEDLE

Applicant Nipro Medical Corp.

K number K052474

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FMI 2005-11-02

EZ-MIO MANUAL DRIVER

Applicant Vidacare Corporation

K number K052195

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FMI 2005-10-20

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM

Applicant Vidacare Corporation

K number K051992

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FMI 2005-10-04

ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES

Applicant Artsana S.P.A

K number K051783

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FMI 2005-09-13

BD PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K051899

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FMI 2005-05-25

ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE

Applicant Atrion Medical Products, Inc.

K number K043249

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FMI 2005-05-11

ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2

Applicant Ultimed, Inc.

K number K050464

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FMI 2005-04-22

STAT MEDICAL PEN NEEDLE

Applicant Emergogroup, Inc.

K number K042917

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FMI 2005-04-05

DEPOTONE

Applicant Imprint Pharmaceuticals Limited

K number K050505

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FMI 2005-03-30

NOVOFINE AUTOCOVER 30G X 8MM

Applicant Novo Nordisk, Inc.

K number K050106

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FMI 2005-02-18

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE

Applicant Vidacare Corporation

K number K043490

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FMI 2004-12-29

MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE

Applicant Becton, Dickinson & CO

K number K043397

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FMI 2004-12-22

NEEDLE INCAPACITATOR (NEEDLE GUARD)

Applicant Pdmp, Inc.

K number K042907

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FMI 2004-12-01

VASCULAR SOLUTIONS SCLERO-KIT

Applicant Vascular Solutions, Inc.

K number K043019

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FMI 2004-09-13

SAFE T RETRACTABLE BLOOD COLLECTION DEVICE

Applicant Safe T Medical Devices, Ltd.

K number K041941

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FMI 2004-07-28

HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE

Applicant Smiths Medical Asd, Inc.

K number K041399

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FMI 2004-07-12

SHARPSAWAY II LOCKING DISPOSABLE CUP

Applicant Arrow Intl., Inc.

K number K041153

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FMI 2004-03-23

TERUMO SURGUARD2 SAFETY NEEDLE

Applicant Terumo Medical Corp.

K number K040531

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FMI 2004-03-10

VIDAPORT INTRAOSSEOUS INFUSION SYSTEM

Applicant Vidacare Corporation

K number K032885

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FMI 2004-02-09

ONE.CLICK NEEDLE

Applicant B.Braun Medical, Inc.

K number K033575

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FMI 2004-01-28

SECUMAX BLOOD COLLECTION SYSTEM

Applicant Tiger Meditech Incorporated

K number K032141

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FMI 2004-01-21

AMERSHAM HEALTH NEEDLE-GUARD

Applicant Gettig Pharmaceutical Instrument Co.

K number K033409

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FMI 2003-12-29

VACUETTE QUICKSHIELD SAFETY TUBE HOLDER

Applicant Greiner Bio-One Vacuette North America

K number K033478

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FMI 2003-11-13

MONOJECT INSULIN SYRINGE

Applicant Tyco Healthcare

K number K033373

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FMI 2003-07-08

TERUMO SURGUARD 2 SAFETY NEEDLE

Applicant Terumo Medical Corp.

K number K031453

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FMI 2003-06-24

MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K031200

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FMI 2003-06-13

CORD STICK MULTIPLE DRAW SYSTEM

Applicant Cord Stick Corp.

K number K031058

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FMI 2003-03-21

CROSSEAL APPLICATION DEVICE

Applicant Omrix Biopharmaceuticals, Inc.

K number K030032

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FMI 2002-12-30

BD ULTRA-FINE III PEN NEEDLE

Applicant Becton, Dickinson & CO

K number K024109

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FMI 2002-11-22

KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX

Applicant Kyung GI Medical Ind. Co., Ltd.

K number K022057

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FMI 2002-10-11

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST

Applicant Waismed, Ltd.

K number K022415

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FMI 2002-09-30

EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET

Applicant Exelint Intl. Co.

K number K022406

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FMI 2002-08-21

SURE-LOK

Applicant Vital Signs, Inc.

K number K021315

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FMI 2002-07-19

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

Applicant Bd

K number K021475

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FMI 2002-07-11

NO-POKES NEEDLE SAFETY DEVICE

Applicant Bemis Mfg. Co.

K number K020921

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FMI 2002-01-23

EXEL COMFORTPOINT INSULIN PEN NEEDLE

Applicant Exelint Intl. Co.

K number K011757

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FMI 2001-12-14

NIPRO HYPODERMIC NEEDLE

Applicant Nipro Medical Corp.

K number K013293

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FMI 2001-11-20

DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE

Applicant Disetronic Medical Systems

K number K013782

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FMI 2001-10-25

MONOJECT SAFETY NEEDLE

Applicant Tyco Healthcare

K number K012736

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FMI 2001-10-01

SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE

Applicant Safegard Medical Products, Inc.

K number K012283

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FMI 2001-09-05

JMS APHERESIS NEEDLE SET ACCORDION TYPE

Applicant Jms Co., Ltd.

K number K002394

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