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 2001-08-29

BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET

Applicant Becton, Dickinson & CO

K number K011984

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FMI 2001-08-27

TERUMO 30 GAUGE HYPODERMIC NEEDLE

Applicant Terumo Medical Corp.

K number K012646

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FMI 2001-08-22

SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1

Applicant Medtech Systems, Inc.

K number K001853

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FMI 2001-07-12

HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO

Applicant Sims Portex, Inc.

K number K011925

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FMI 2001-07-12

VACUETTE SAFETY BLOOD COLLECTION SET

Applicant Greiner Vacuette North America, Inc.

K number K011786

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FMI 2001-06-08

INSULIN PEN NEEDLE ADAPTER

Applicant Ohana Needle Co.

K number K010887

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FMI 2001-05-24

NEEDLELOK HYPODERMIC NEEDLE PROTECTION

Applicant Diasol, Inc.

K number K011004

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FMI 2001-05-18

FISTULOK FISTULA NEEDLE PROTECTION

Applicant Diasol, Inc.

K number K010958

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FMI 2001-04-30

VACUETTE SPEEDY QUICK-RELEASE HOLDER

Applicant Greiner Vacuette North America, Inc.

K number K003812

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FMI 2001-04-23

SHIELDING NEEDLE HOLDER

Applicant U.S. Safety Syringes Co., Inc.

K number K003381

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FMI 2001-04-19

DISPO-MED 7.6 LITER SHARPS CONTAINER

Applicant Master Benefits, Inc.

K number K003521

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FMI 2001-03-30

SARSTEDT NEEDLE PROTECTOR

Applicant Sarstedt, Inc.

K number K003382

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FMI 2001-03-01

BD ECLIPSE HYPODERMIC NEEDLE

Applicant Bd Medical Systems

K number K010188

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FMI 2001-02-08

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

Applicant Exelint International, Co.

K number K003627

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FMI 2001-02-02

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS

Applicant North American Medical Products, Inc.

K number K001965

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FMI 2001-02-01

BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K003461

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FMI 2001-01-24

NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

Applicant Cambridge Marketing, Inc.

K number K010038

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FMI 2001-01-12

GUARDED NEEDLE 2000

Applicant International Medical Device Partners, Inc.

K number K003406

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FMI 2001-01-08

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION

Applicant Bio-Plexus, Inc.

K number K003827

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FMI 2000-12-21

VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET

Applicant Med-Pro Technologies, Inc.

K number K000714

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FMI 2000-12-08

NOVOFINE 31 DISPOSABLE NEEDLE

Applicant Novo Norodisk Pharmaceuticals, Inc.

K number K002403

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FMI 2000-11-29

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K002938

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FMI 2000-10-13

SIMPLICITY DISPOSABLE PEN NEEDLE

Applicant Sterling Medivations, Inc.

K number K002180

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FMI 2000-10-03

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID

Applicant Hunter Research Laboratories, Inc.

K number K002213

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FMI 2000-09-18

SERAGARD VASCULAR ACCESS PATCH

Applicant Platinum Services, Inc.

K number K001175

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FMI 2000-08-14

NEOLUS NEEDLE

Applicant Terumo Europe N.V.

K number K001572

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FMI 2000-07-31

PROTECTIV SAFETY BLOOD COLLECTION NEEDLE

Applicant Johnson & Johnson Medical, Inc.

K number K001690

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FMI 2000-06-20

SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM

Applicant Safety Medical Supply Int,., Inc.

K number K993125

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FMI 2000-05-18

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

Applicant Pro. Duct Health, Inc.

K number K001098

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FMI 2000-04-19

GETTIG GUARD

Applicant Gettig Pharmaceutical Instrument Co.

K number K000455

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FMI 2000-04-11

BODYGUARD

Applicant Vital Signs, Inc.

K number K000441

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FMI 2000-03-30

VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

Applicant Medpro Technologies, Inc.

K number K000369

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FMI 2000-03-17

PORTSETT

Applicant Portsett, Inc.

K number K000085

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FMI 2000-03-08

LUER ACCESS UNIVERSAL VIAL ADAPTER

Applicant Baxter Healthcare Corp

K number K000657

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FMI 2000-03-02

TERUMO NEEDLE WITH LOCKING SHEATH

Applicant Terumo Medical Corp.

K number K000387

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FMI 2000-02-14

NIPRO BLOOD COLLECTION NEEDLE

Applicant Nipro Medical Corp.

K number K992699

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FMI 2000-01-13

NIPRO LUER ADAPTOR

Applicant Nipro Medical Corp.

K number K992729

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FMI 1999-12-29

DISENTRONIC PENFINE INJECTION PEN NEEDLE

Applicant Disetronic Medical Systems

K number K994197

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FMI 1999-12-16

SURE-WAY REUSABLE SHARPS CONTAINER

Applicant Sure-Way Systems, Inc.

K number K992626

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FMI 1999-09-09

PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750

Applicant Bio-Plexus, Inc.

K number K992091

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FMI 1999-08-31

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES

Applicant Jms Co., Ltd.

K number K991904

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FMI 1999-06-14

K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K

Applicant Terumo Europe N.V.

K number K984576

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FMI 1999-05-18

THE VAULT

Applicant Stik Stoppers, Inc.

K number K990936

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FMI 1999-05-14

PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)

Applicant Itl Corporation Pty, Ltd.

K number K991404

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FMI 1999-04-21

DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950

Applicant Post Medical, Inc.

K number K990371

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FMI 1999-04-06

SHARPS COLLECTION CONTAINER - SAF-T-SHELL

Applicant American Medical Mfg., Inc.

K number K982029

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FMI 1998-11-30

DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER

Applicant Deroyal Industries, Inc.

K number K983750

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FMI 1998-11-17

BONE INJECTION GUN (B.I.G.) DEVICE

Applicant Waismed, Ltd.

K number K981853

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FMI 1998-10-30

FINE-JECT

Applicant Henke Sass Wolf of America, Inc.

K number K983067

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FMI 1998-10-28

VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608

Applicant Becton Dickinson Vacutainer Systems

K number K982541

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FMI 1998-09-25

BLUNT SYRINGE CANNULA

Applicant B.Braun Medical, Inc.

K number K971924

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FMI 1998-08-06

DISETRONIC PENFINE INJECTION PEN NEEDLE

Applicant Disetronic Medical Systems

K number K982399

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FMI 1998-07-15

VACUETTE MULTIPLE SAMPLE LUER ADAPTER

Applicant Greiner Meditech, Inc.

K number K981619

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FMI 1998-07-15

FLOW-EZE BLUNT CANNULA (1999BC)

Applicant Acacia, Inc.

K number K972538

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FMI 1998-06-25

WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD

Applicant Worldwide Medical Technologies, LLC

K number K982097

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FMI 1998-06-22

SHARPTRACK REUSABLE SHARPS CONTAINER

Applicant Bfi- Medical Waste Systems

K number K981184

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FMI 1998-06-03

BECTON DICKINSON BLUNT PLASTIC CANNULA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K974363

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FMI 1998-05-05

EXEL AVF SINGLE NEEDLE

Applicant Exel Intl.

K number K963658

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FMI 1998-04-30

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC

Applicant Sage Products, Inc.

K number K972705

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FMI 1998-04-23

MANAN GALACTOGRAPHY KIT

Applicant Medical Device Technologies, Inc.

K number K980227

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FMI 1998-04-13

SHARPS PLUS 5 GALLON SHARPS CONTAINER

Applicant Rotonics Mfg., Inc.

K number K980179

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FMI 1998-04-09

VACUETTE HOLDEX

Applicant Greiner Meditech, Inc.

K number K980768

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FMI 1998-03-20

MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE

Applicant Davis & Geck, Inc.

K number K980062

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FMI 1998-03-13

M500-100 SHARPS CONTAINER

Applicant Imagination Medical, Inc.

K number K980003

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FMI 1998-01-22

BECTON DICKINSON TWINPAK

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K974006

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FMI 1997-12-17

VACUETTE MULTI-SAMPLE NEEDLE

Applicant Greiner Meditech, Inc.

K number K973620

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FMI 1997-12-04

UNIFINE PENTIPS

Applicant Owen Mumford USA, Inc.

K number K973899

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FMI 1997-11-05

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM

Applicant MDC Research , Ltd.

K number K973012

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FMI 1997-10-29

2 GALLON ALTERNATE CARE SHARPS CONTAINER

Applicant Sage Products, Inc.

K number K973911

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FMI 1997-09-24

DISETRONIC PENFINE INJECTION PEN NEEDLE

Applicant Disetronic Medical Systems

K number K973339

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FMI 1997-09-04

BKMI DISPOSABLE SYRINGE

Applicant Sumi Salud C.A.

K number K971487

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FMI 1997-08-29

SHARPS SHUTTLE

Applicant Sage Products, Inc.

K number K972279

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FMI 1997-08-27

SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE

Applicant Beech Medical Products, Inc.

K number K972469

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FMI 1997-08-26

BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER

Applicant Retractable Technologies, Inc.

K number K971763

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FMI 1997-08-15

SYRINGE NEEDLE REMOVER (S.N.R.)

Applicant Post Medical, Inc.

K number K972536

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FMI 1997-07-18

ISOLYSER SDS SHARPS CONTAINER

Applicant Thantex Specialties, Inc.

K number K970547

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FMI 1997-07-03

SHARPS CONTAINER

Applicant Custom Medical Plastics, Inc.

K number K970398

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FMI 1997-07-03

SHARPS CONTAINER

Applicant Custom Medical Plastics, Inc.

K number K970383

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FMI 1997-06-06

EXTRESAFE PHLEBOTOMY

Applicant Specialized Health Products, Inc.

K number K964042

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FMI 1997-06-06

BIO-PLEXUS DROP-IT NEEDLE HOLDER

Applicant Bio-Plexus, Inc.

K number K963748

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FMI 1997-06-02

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR

Applicant Vygon Corp.

K number K963571

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FMI 1997-04-25

F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM

Applicant Pyng Medical Corp.

K number K970380

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FMI 1997-04-10

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

Applicant Tsk Laboratory, Japan

K number K970370

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FMI 1997-04-02

BECTON DICKINSON BLUNT PLASTIC CANNULA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K964654

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FMI 1997-03-28

B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K970737

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FMI 1997-02-26

LIFESHIELD BLUNT CANNULA

Applicant Abbott Laboratories

K number K963351

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FMI 1997-02-14

BEMIS TWO GALLON SHARPS CONTAINER

Applicant Bemis Mfg. Co.

K number K965248

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FMI 1997-02-10

SHARPS CONTAINER MODEL# SC001

Applicant Image Medical, Inc.

K number K963830

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FMI 1997-01-10

MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE

Applicant Manan Medical Products, Inc.

K number K962001

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FMI 1997-01-06

SERAGARD VASCULAR ACCESS DEVICE

Applicant Cutting Edge Technologies, Inc.

K number K963595

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FMI 1996-12-23

MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA

Applicant Sherwood Medical Co.

K number K960982

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FMI 1996-10-24

I.V. START KIT

Applicant James J. Schramm

K number K950686

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FMI 1996-10-11

SAFETY CRADLE

Applicant Specialized Health Products, Inc.

K number K962149

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FMI 1996-08-28

BIO-PLEXUS NEEDLE DISPOSAL CONTAINER

Applicant Bio-Plexus, Inc.

K number K960933

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FMI 1996-08-07

PISTON SYRINGE

Applicant Univec, Inc.

K number K961877

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FMI 1996-07-08

CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES

Applicant Ttk Biomed, Ltd.

K number K955772

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FMI 1996-07-02

NON-CORING NEEDLE

Applicant Arrow Intl., Inc.

K number K961088

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FMI 1996-06-27

SHARPS-TAINER

Applicant Winfield Industries

K number K961878

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FMI 1996-06-27

PUNCTUR-GUARD WINGED SET

Applicant Bio-Plexus, Inc.

K number K961251

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FMI 1996-06-25

RNS ARTHROGRAM TRAY

Applicant Contour Fabricators of Florida, Inc.

K number K962040

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