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 1993-10-19

HAN-D-AID

Applicant Salmon Ent.

K number K924793

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FMI 1993-10-18

BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K931019

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FMI 1993-10-05

HYPOGRIP(TM)

Applicant Collett Products

K number K924820

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FMI 1993-07-29

BARD SAFE SAMPLING DEVICE

Applicant C.R. Bard, Inc.

K number K925446

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FMI 1993-07-02

CATHETER INSERTION TRAY

Applicant Medcare Custom Packaging, Inc.

K number K922179

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FMI 1993-06-07

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM

Applicant Surgical Dynamics, Inc.

K number K921950

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FMI 1993-04-29

NEEDLE-PRO CARTRIDGE

Applicant Concord/Portex

K number K923127

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FMI 1993-03-18

B-D PEN NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K924070

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FMI 1993-02-12

BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K924439

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FMI 1992-12-15

LIFESHIELD VIAL ADAPTER

Applicant Abbott Laboratories

K number K920737

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FMI 1992-07-21

PROTECTOR SYRINGE SAFETY CAP SYSTEM

Applicant Injectimed, Inc.

K number K922158

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FMI 1992-04-22

NEEDLEGARD II

Applicant Ingenious Technologies Corp.

K number K920717

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FMI 1992-03-04

INTRAOSSEOUS ACCESS NEEDLE

Applicant Cook, Inc.

K number K915409

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FMI 1992-03-04

DISPOSABLE INTROSSEOUS INFUSION NEEDLES

Applicant Cook, Inc.

K number K913258

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FMI 1992-01-10

CHEMO-PORT

Applicant Hdc Corp.

K number K913386

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FMI 1991-12-13

RINN E-Z CAPPER

Applicant Rinn Corp.

K number K913885

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FMI 1991-11-27

MX927 BLOOD TRANSFER DEVICE

Applicant Medex, Inc.

K number K913498

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FMI 1991-10-31

MEGA ARTHROGRAM KIT

Applicant Mega Medical, Inc.

K number K913317

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FMI 1991-10-17

MEGA MYELOGRAM KIT

Applicant Megadyne Medical Products, Inc.

K number K913141

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FMI 1991-10-08

PROGUARDII(TM) BLOOD COLLECTION DEVICE

Applicant Care Medical Devices, Inc.

K number K913914

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FMI 1991-09-04

STERI-STAT REUSABLE SYRINGE

Applicant David Craig Marketing, Inc.

K number K910667

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FMI 1991-08-23

V-ACCI-GUARD(TM) REUSABLE HOLDER

Applicant Medical Safety Products, Inc.

K number K913329

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FMI 1991-07-26

THE NEEDLE NABBER

Applicant J. Simmons Instrument , Ltd.

K number K911597

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FMI 1991-07-01

SHARPS PIN CUSHION(TM) CONTAINER

Applicant Catalyst, Inc.

K number K911436

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FMI 1991-06-06

MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE

Applicant Medisystems Corp.

K number K910733

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FMI 1991-06-06

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE

Applicant Gainor Medical Europe, Ltd.

K number K902422

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FMI 1991-05-03

SAFETY NEEDLE SHEATH, MODIFICATION

Applicant Concord/Portex

K number K911037

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FMI 1991-03-15

VIAL ACCESS CANNULA

Applicant Baxter Healthcare Corp

K number K905664

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FMI 1991-02-14

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR

Applicant Ziehm International, Inc.

K number K910455

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FMI 1991-02-12

SAFE-SITE NEEDLE COVER

Applicant North American Medical Products, Inc.

K number K905305

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FMI 1990-12-19

SAFETY NEEDLE SHEATH

Applicant Concord/Portex

K number K904198

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FMI 1990-12-14

CAP-AID

Applicant Nda Systems

K number K904107

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FMI 1990-11-28

NORPLANT(R) TROCAR

Applicant Wyeth-Ayerst Laboratories, Inc.

K number K903490

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FMI 1990-10-15

PROGUARD(TM) BLOOD COLLECTION NEEDLE

Applicant Safety-Ject, Inc.

K number K904295

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FMI 1990-09-28

STERIMATIC(TM) SAFETY NEEDLE

Applicant Sterimatic Worldwide, Ltd.

K number K901162

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FMI 1990-09-21

PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

Applicant Bio-Plexus, Inc.

K number K895024

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FMI 1990-09-07

SHARGHP HYPODERMIC NEEDLE

Applicant Shargh Pharmaceutical Co., Inc.

K number K895811

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FMI 1990-02-28

NEEDLE-SHIELD

Applicant Macbrud Corp. Medical Div.

K number K900282

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FMI 1990-02-16

EXEL SPINAL NEEDLES

Applicant Exel Intl.

K number K895771

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FMI 1990-02-16

EXEL HUBER NEEDLE

Applicant Exel Intl.

K number K895769

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FMI 1990-01-18

VIRAFREE CORP. EJECTABLE NEEDLE HOLDER

Applicant Virafree Corp.

K number K896293

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FMI 1990-01-11

CENTURION KLEEN-NEEDLE SYSTEM

Applicant Tri-State Hospital Supply Corp.

K number K896320

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FMI 1989-12-08

B-D PEND NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K895630

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FMI 1989-11-03

SAFE-T-CAP

Applicant Ausmedics Pty , Ltd.

K number K895432

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FMI 1989-10-31

ACCI-GUARD REUSABLE HOLDER

Applicant Medical Safety Products, Inc.

K number K895075

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FMI 1989-10-10

SHAMROCK SAFETY BLOOD COLLECTION SET

Applicant Ryan Medical, Inc.

K number K895705

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FMI 1989-09-28

BLOOD DRAWING NEEDLE

Applicant Pharma-Plast USA, Inc.

K number K894374

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FMI 1989-09-28

NIPRO NEEDLE HOLDER

Applicant Pharma-Plast USA, Inc.

K number K894372

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FMI 1989-06-20

SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE

Applicant Meadox Surgimed, Inc.

K number K890926

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FMI 1989-05-05

INTRAVASCULAR ADMINISTRATION SET

Applicant Multi-Med, Inc.

K number K891919

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FMI 1989-04-03

NEEDLE GUARD(TM)

Applicant Martech Medical Products, Inc.

K number K890473

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FMI 1989-03-14

NEEDLE STICK

Applicant Poncy, Inc.

K number K885122

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FMI 1989-02-28

STICK-GARD SAFETY NEEDLE

Applicant Ziehm International, Inc.

K number K890620

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FMI 1989-02-03

INTRAVASCULAR ADMINISTRATION SET

Applicant Multi-Med, Inc.

K number K890127

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FMI 1989-01-30

VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES

Applicant Infucare Products, Inc.

K number K884792

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FMI 1988-11-21

ASD SINGLE LUMEN NEEDLE

Applicant Biosurge, Inc.

K number K884620

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FMI 1988-10-17

WINGED NON-CORING NEEDLE SET

Applicant Marquette Medical, Inc.

K number K884212

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FMI 1988-10-17

STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES

Applicant Marquette Medical, Inc.

K number K884211

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FMI 1988-10-06

ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER

Applicant Medical Safety Products, Inc.

K number K884139

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FMI 1988-10-04

NON-CORING NEEDLES

Applicant Quinton, Inc.

K number K883009

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FMI 1988-08-09

SAFETY, BLOOD COLLECTION TUBE HOLDER

Applicant Ryan Medical, Inc.

K number K882880

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FMI 1988-07-08

LO-CORE NEEDLE

Applicant Device Labs, Inc.

K number K882064

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FMI 1988-07-08

ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE

Applicant Medical Safety Products, Inc.

K number K881654

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FMI 1988-06-15

MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT

Applicant Manan Medical Devices

K number K881671

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FMI 1988-06-03

VIGGO VASCUPORT NEEDLE

Applicant Ohmeda Medical

K number K881758

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FMI 1988-05-31

N.S. CADEE

Applicant First Scientific, Div.

K number K881785

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FMI 1988-05-31

STERILE NEEDLE FOR BLOOD COLLECTION

Applicant Applied Plastics Technology, Inc.

K number K880746

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FMI 1988-04-21

BLOOD COLLECTING NEEDLE AND HOLDERS

Applicant Abco Dealers, Inc.

K number K880892

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FMI 1988-02-19

ASD-BIO ANTI-STICK DEVICE

Applicant Biosurge, Inc.

K number K874602

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FMI 1988-01-14

HYPODERMIC NEEDLES, SINGLE LUMEN

Applicant Harbor Medical Devices, Inc.

K number K874414

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FMI 1988-01-04

NEEDLE CONTAINER

Applicant American Medical Technology, Inc.

K number K874430

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FMI 1987-12-30

LAKE IRRIGATION TRAY

Applicant Lake Medical Products, Inc.

K number K873991

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FMI 1987-12-03

CHEMO-PORT NON-CORING NEEDLES

Applicant Hdc Corp.

K number K873165

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FMI 1987-11-23

ACU-MICRO-NEEDLE

Applicant Acuderm, Inc.

K number K874024

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FMI 1987-11-06

HR(TM) NEEDLE AND SYRINGE

Applicant Icu Medical, Inc.

K number K874372

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FMI 1987-11-03

BIFURCATED NEEDLE

Applicant Allergy Laboratories of Ohio, Inc.

K number K874249

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FMI 1987-11-03

BLOOD NEEDLE HOLDER

Applicant Sage Products, Inc.

K number K873569

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FMI 1987-10-23

NON-CORING HUBER TYPE NEEDLES

Applicant Advantage Medical Systems, Inc.

K number K873957

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FMI 1987-08-25

MULTIPLE NEEDLE, INJECTION, DISPOSABLE

Applicant Cotran Corp.

K number K872566

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FMI 1987-08-13

HR (TM) COLLECTION SYSTEM

Applicant Icu Medical, Inc.

K number K872580

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FMI 1987-06-29

ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP)

Applicant Peachtree Medical, Inc.

K number K871142

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FMI 1987-05-08

FNA THYROID BIOPSY KIT

Applicant Flint Laboratories Div. Travenol

K number K870863

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FMI 1987-02-27

A+MED DISPOSABLE NEEDLE

Applicant Can-Am Surgical Corp.

K number K870193

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FMI 1987-02-04

ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K862610

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FMI 1987-01-20

RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE

Applicant Rymco Ltda

K number K864310

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FMI 1986-12-18

BUTTERFLY NON-CORING NEEDLE SET

Applicant Cormed, Inc., Sub. C.R.Bard, Inc.

K number K863606

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FMI 1986-09-25

PROMEDICOR

Applicant Terra Marketing Assoc.

K number K863514

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FMI 1986-07-17

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET

Applicant Baxter Healthcare Corp

K number K861390

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FMI 1986-05-12

MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE

Applicant Medi Point, Inc.

K number K861560

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FMI 1986-05-06

NON-KOR WINGED INFUSION SETS

Applicant Creative Care Systems, Inc.

K number K861406

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FMI 1986-05-06

EXEL VACUUM BLOOD COLLECTING SYSTEM

Applicant Exel Intl.

K number K861152

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FMI 1986-05-06

ICU MEDICAL NEEDLE, LOPEZ NEEDLE

Applicant Icu Medical, Inc.

K number K860781

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FMI 1986-05-02

DISPOSABLE NEEDLE COUNTER (20-720)

Applicant Anago, Inc.

K number K861318

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FMI 1986-04-09

DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH

Applicant Perkins & Perkins, Inc.

K number K861081

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FMI 1986-03-21

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE

Applicant Medical Hospital Equipment

K number K852615

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FMI 1986-02-26

BLOOD COLLECTING NEEDLE

Applicant Churchill Corp.

K number K855248

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FMI 1986-02-04

MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU

Applicant Sherwood Medical Co.

K number K854549

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FMI 1986-02-04

MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES

Applicant Sherwood Medical Co.

K number K854548

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FMI 1986-02-04

MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE

Applicant Sherwood Medical Co.

K number K854547

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FMI 1985-11-12

ACE-KYLE DYE INJECTION NEEDLE P/N 14082

Applicant Today'S Machining & Design, Inc.

K number K853604

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