Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

FDA product code FOZ · 489 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5200
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2026-09-02

FOZ 2026-09-02

Ruby Intravascular Catheter

Applicant Venocare, Inc.

K number K260432

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FOZ 2026-08-10

Unimpregnated Central Venous Catheter

Applicant Spectrum Vascular

K number K260165

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FOZ 2026-07-10

ClearSafe Closed System

Applicant MedSource Labs, LLC

K number K261041

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FOZ 2026-07-09

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter

Applicant MedSource Labs, LLC

K number K260539

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FOZ 2026-05-15

Introcan Safety® Deep Access XL IV Catheter

Applicant B.Braun Medical, Inc.

K number K253235

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FOZ 2026-04-02

BD Insyte™ IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K252137

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FOZ 2026-04-01

Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

Applicant Poly Medicure Limited

K number K252513

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FOZ 2025-12-17

SURFLO Hybria Closed System Safety IV Catheter

Applicant Terumo Medical Products (Hangzhou) Co., Ltd.

K number K252398

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FOZ 2025-11-05

Polyshield Safety IV Catheters

Applicant Poly Medicure Limited

K number K252677

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FOZ 2025-10-08

BD Saf-T-Intima™ Subcutaneous Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K251422

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FOZ 2025-07-25

BD Nexiva™ Closed IV Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K243403

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FOZ 2025-07-11

BD Cathena™ Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K251155

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FOZ 2025-06-27

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K251654

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FOZ 2025-06-03

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K250682

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FOZ 2025-05-16

Ruby Intravascular Catheter

Applicant Venocare, Inc.

K number K243105

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FOZ 2025-05-02

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

Applicant Skydance Vascular, Inc.

K number K250292

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FOZ 2025-03-27

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

Applicant Access Vascular, Inc.

K number K244059

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FOZ 2025-03-14

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K number K243599

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FOZ 2024-12-20

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K number K242281

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FOZ 2024-11-27

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Applicant Spectrum Vascular

K number K241115

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FOZ 2024-07-29

PowerGlide Pro™ Midline Catheter

Applicant Becton, Dickinson and Company (Bard Access Systems, Inc.)

K number K240359

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FOZ 2024-07-26

Introcan Safety® 2 IV Catheter

Applicant B.Braun Medical, Inc.

K number K241845

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FOZ 2024-04-19

AccuCath Ace™ Intravascular Catheter

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K number K233106

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FOZ 2024-03-15

Nouvo Safety Set

Applicant Poly Medicure Limited

K number K232234

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FOZ 2023-12-01

BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K233529

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FOZ 2023-09-22

Nexiva™ Closed IV Catheter System with NearPort™ IV Access

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K231239

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FOZ 2023-09-21

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

Applicant Poly Medicure Limited

K number K231401

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FOZ 2023-09-15

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

Applicant Medsource International, LLC

K number K223788

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FOZ 2023-08-31

OSPREY Closed IV Catheter System (OspreyV2)

Applicant Skydance Vascular, Inc.

K number K231626

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FOZ 2023-06-23

Mais Central Venous Catheter

Applicant Saudi Mais Co. For Medical Products

K number K221827

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FOZ 2023-05-05

Polyguard and Polyshield Safety IV Catheters

Applicant Poly Medicure Limited

K number K230616

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FOZ 2023-04-14

OSPREY PERIPHERAL IV Catheter System

Applicant Skydance Vascular, Inc.

K number K223018

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FOZ 2023-02-03

Cook® Spectrum® 2 MRC Central Venous Catheter

Applicant Cook Advanced Technologies

K number K223648

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FOZ 2022-12-07

HydroMID 4F Single Lumen Midline Catheter

Applicant Access Vascular, Inc.

K number K220772

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FOZ 2022-09-13

MagiCath II

Applicant Woo Young Medical Co., Ltd.

K number K210929

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FOZ 2022-08-29

Leaderflex Mini and Leaderflex Nano

Applicant Vygon USA

K number K212370

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FOZ 2022-06-23

Introcan Safety 2 IV Catheter

Applicant B.Braun Medical, Inc.

K number K220756

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FOZ 2022-05-14

Introcan Safety IV Catheter

Applicant B.Braun Medical, Inc.

K number K220626

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FOZ 2022-03-31

BD Cathena Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K220584

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FOZ 2022-03-25

Pluski Safe 1 Safety IV Catheter

Applicant Mediplus (India) Limited

K number K210037

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FOZ 2022-02-11

B. Braun Introcan Safety 2 IV Catheter

Applicant B.Braun Medical, Inc.

K number K213664

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FOZ 2021-10-25

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Medical, Inc.

K number K213085

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FOZ 2021-07-23

Disposable IV catheter

Applicant Shinva Ande Healthcare Apparatus Co., Ltd.

K number K202060

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FOZ 2021-06-02

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

Applicant Becton, Dickinson and Company

K number K200891

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FOZ 2021-02-08

HydroMID

Applicant Access Vascular, Inc.

K number K203069

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FOZ 2020-12-18

BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

Applicant Becton, Dickinson and Company

K number K201075

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FOZ 2020-11-24

ACENT™ Central Venous Catheter

Applicant Global Medikit Limited

K number K193158

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FOZ 2020-09-22

BD Cathena Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K201717

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FOZ 2020-08-26

Deltaven Fast Flash Closed I.V. Catheter Systems

Applicant Delta Med Spa

K number K200373

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FOZ 2020-08-07

MedSource CathMED IV Catheter

Applicant Medsource Labs

K number K193278

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FOZ 2020-04-23

MF SAFECATH

Applicant Medifirst Co., Ltd.

K number K192230

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FOZ 2020-04-07

BD Centro Vena Acute Central Line (7 French Dual Lumen)

Applicant Bard Access Systems, Inc. (Bard Has Joined Bd)

K number K200266

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FOZ 2020-04-01

Introcan Safety 2 IV Catheter 18-24 gauge

Applicant B.Braun Medical, Inc.

K number K192676

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FOZ 2020-03-12

Health Line CT Midline Catheter

Applicant Health Line International Corporation

K number K200263

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FOZ 2020-01-24

BD Cathena (TM) Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K192493

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FOZ 2019-12-10

Health Line CT CVC

Applicant Health Line International Corporation

K number K192533

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FOZ 2019-11-01

BD Acute Central Line

Applicant Bard Access Systems, Inc. (Bard Has Joined Bd)

K number K190855

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FOZ 2019-09-20

Supercath 5

Applicant Togo Medikit Co., Ltd.

K number K190001

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FOZ 2019-09-18

AccuCath Ace Intravascular Catheter

Applicant C.R. Bard, Inc.

K number K191232

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FOZ 2019-05-17

Cook Unimpregnated Central Venous Catheter

Applicant Cook Incorporated

K number K182252

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FOZ 2019-03-20

BD Nexiva Closed IV Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K183399

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FOZ 2019-03-07

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Medical, Inc.

K number K182870

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FOZ 2019-01-16

Merit RadialFlo Arterial Catheter

Applicant Merit Medical Singapore Pte. , Ltd.

K number K182538

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FOZ 2018-03-23

SUPERCATH 5 (26G)

Applicant Togo Medikit Co., Ltd.

K number K172496

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FOZ 2017-12-21

Deltaven XiV Max, Deltaven XiV Max FF

Applicant Delta Med Spa

K number K171530

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FOZ 2017-12-15

BD Nexiva Diffusics Closed IV Catheter Systems

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K173354

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FOZ 2017-09-17

BD Cathena Safety IV Catheter

Applicant Becton, Dickinson and Company

K number K172506

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FOZ 2017-08-17

BD Intima II PLUS Closed IV Catheter System

Applicant Becton, Dickinson and Company

K number K172204

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FOZ 2017-04-28

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Melsungen AG

K number K163358

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FOZ 2017-03-10

BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector

Applicant Becton, Dickinson and Company

K number K170336

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FOZ 2017-03-08

Nipro SafeTouch IV Catheter

Applicant Nipro Medical Corporation

K number K161681

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FOZ 2017-02-28

BD Nexiva Diffusics Closed IV Catheter System

Applicant Becton, Dickinson and Company

K number K170283

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FOZ 2017-02-24

Arrow Endurance Extended Dwell Peripheral Catheter System

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

K number K163513

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FOZ 2016-11-15

AccuCath Intravascular Catheter

Applicant C.R. Bard, Inc.

K number K162894

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FOZ 2016-11-03

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

Applicant Medsource International, LLC

K number K161779

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FOZ 2016-09-22

PowerGlide Pro Midline Catheter

Applicant C.R. Bard, Inc.

K number K162377

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FOZ 2016-09-08

BioFlo Midline Catheter

Applicant Navilyst Medical, Inc.

K number K161866

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FOZ 2016-08-29

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K161777

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FOZ 2016-08-12

SUPERCATH 6

Applicant Togo Medikit Co., Ltd.

K number K160592

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FOZ 2016-06-30

ViaValve Safety I.V. Catheter

Applicant Smiths Medical Asd, Inc.

K number K160235

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FOZ 2016-06-02

PowerGlide Pro Midline Catheter

Applicant C.R. Bard, Inc.

K number K153280

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FOZ 2016-03-11

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

Applicant Tangent Medical Technologies, Inc.

K number K160374

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FOZ 2013-12-05

SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER

Applicant Nipro Medical Corporation

K number K132153

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FOZ 2013-04-30

MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER

Applicant Luther Needlesafe Products, Inc.

K number K130518

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FOZ 2013-03-05

JMS SAFE WING CATH (SWC)

Applicant JMS North America Corporation

K number K121488

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FOZ 2013-01-17

BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K123734

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FOZ 2012-12-28

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1

Applicant Delta Med Srl

K number K121007

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FOZ 2012-11-02

SURFFLASH(R) PLUS SAFETY I.V. CATHETER

Applicant Kofu Factory of Terumo Corp.

K number K123267

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FOZ 2012-09-05

TERUMO SURFLASH SAFETY I.V. CATHETER

Applicant Terumo Corporation

K number K122544

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FOZ 2012-07-20

NOVACATH SECURE IV CATHETER SYSTEM-18G

Applicant Tangent Medical Technologies, Inc.

K number K120839

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FOZ 2012-07-11

M/29TM - PRESSURE INJECTABLE

Applicant Flexicath , Ltd.

K number K111939

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FOZ 2012-06-01

POWERGLIDE MIDLINE CATHETER

Applicant C.R. Bard, Inc.

K number K121073

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FOZ 2012-05-18

ORION II CT CVC

Applicant Health Line International Corporation (Hlic)

K number K113622

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FOZ 2012-05-18

MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN

Applicant Edwards Lifesciences, LLC

K number K113565

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FOZ 2012-04-16

SUPERCATH Z3V

Applicant Togo Medikit Co., Ltd.

K number K112290

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FOZ 2012-03-14

VIAVALVE SAFETY IV CATHETER

Applicant Smiths Medical Asd, Inc.

K number K113700

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FOZ 2012-03-12

SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER

Applicant Nipro Medical Corporation

K number K113429

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FOZ 2012-02-16

I-PORT ADVANCE INJECTION PORT

Applicant Unomedical A/S

K number K120337

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FOZ 2012-02-08

YOMURA SAFETY I.V. CATHETER

Applicant Yomura Technologies, Inc.

K number K112542

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FOZ 2011-12-21

AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS

Applicant Ameco Medical Industries

K number K110794

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