Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Syringe, Piston

FDA product code FMF · 731 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5860
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2026-08-26

FMF 2010-08-20

INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)

Applicant Inviro Medical Devices, Inc.

K number K101359

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FMF 2010-08-17

HUMAPEN LUXURA HD

Applicant Eli Lilly and Company

K number K100988

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FMF 2010-06-24

MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX

Applicant Needle Tech Products, Inc.

K number K100665

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FMF 2010-06-09

GRAFT DELIVERY SYSTEM MODEL SA-6115

Applicant Micromedics, Inc.

K number K100754

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FMF 2010-05-10

EPIDRUM

Applicant Exmoor Plastics , Ltd.

K number K093863

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FMF 2010-04-01

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

Applicant Unilife Medical Solutions Limited

K number K093400

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FMF 2010-03-12

COAXIAL APPLICATOR SYSTEM

Applicant Biomet, Inc.

K number K091722

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FMF 2010-03-10

NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO

Applicant Neomed, Inc.

K number K092908

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FMF 2009-10-27

ACACIA PISTON SYRINGE

Applicant Acacia, Inc.

K number K092986

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FMF 2009-08-21

XTRACT SYRINGE KEYS

Applicant Xtract Solutions, LLC

K number K091200

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FMF 2009-08-12

NIPRO DISPOSABLE SYRINGE

Applicant Nipro Medical Corporation

K number K091279

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FMF 2009-08-06

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

Applicant Shina Corp.

K number K091167

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FMF 2009-07-09

EASY.TOUCH INSULIN SYRINGE

Applicant Masters Healthcare, LLC

K number K091474

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FMF 2009-07-02

BD FLU+ SYRINGE

Applicant Becton, Dickinson & CO

K number K091377

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FMF 2009-07-02

BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

Applicant Anhui Kangda Medical Products Co., Ltd.

K number K083686

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FMF 2009-06-30

XPRESSE INJECTION SYSTEM

Applicant Nordson Efd

K number K083583

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FMF 2009-06-12

STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE

Applicant Shanghai Double Dove Industrial Co., Ltd.

K number K090929

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FMF 2009-06-05

COVIDIEN EXTENDED TIP APPLICATOR

Applicant Confluent Surgical,Inc

K number K091315

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FMF 2009-05-22

TERUMO SYRINGE WITH/WITHOUT NEEDLE

Applicant Terumo Europe N.V.

K number K083514

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FMF 2009-02-20

EVICEL APPLICATION DEVICE

Applicant Omrix Biopharmaceuticals , Ltd.

K number K090162

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FMF 2009-02-13

TACTIPEN

Applicant Haselmeier GmbH

K number K083457

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FMF 2009-02-13

REVAC AUTO RETRACTABLE SAFETY SYRINGE

Applicant Revolutions Medical Corporation, Inc.

K number K083193

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FMF 2008-11-28

SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE

Applicant Spectra Medical Devices, Inc.

K number K082674

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FMF 2008-11-07

MICROMYST APPLICATOR, MODEL 20-5000

Applicant Covidien

K number K082454

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FMF 2008-10-22

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES

Applicant Inviro Medical Devices, Inc.

K number K081436

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FMF 2008-09-26

HASELMEIER PEN 8

Applicant Haselmeier GmbH

K number K082616

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FMF 2008-09-08

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC

Applicant Bio-Med USA, Inc.

K number K081547

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FMF 2008-09-08

WEIGAO EMPTY CARTRIDGE SYRINGE

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K number K081241

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FMF 2008-07-29

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L

Applicant Spectra Medical Devices, Inc.

K number K081524

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FMF 2008-05-02

UNIVERSAL VIAL ACCESS SPIKE

Applicant Icu Medical, Inc.

K number K080989

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FMF 2008-01-11

CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008

Applicant Confluent Surgical,Inc

K number K072790

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FMF 2007-12-14

PATIENT SAFE SYRINGE

Applicant Retractable Technologies, Inc.

K number K072654

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FMF 2007-12-06

CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM

Applicant Biomet, Inc.

K number K072330

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FMF 2007-10-05

ICU MEDICAL SINGLE-USE SYRINGE

Applicant Icu Medical, Inc.

K number K070856

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FMF 2007-10-04

POWRSYRINGE ASPIRATOR

Applicant Pinyons Medical Technology, Inc.

K number K072299

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FMF 2007-09-21

POWRSYRINGE MONITOR

Applicant Pinyons Medical Technology, Inc.

K number K072345

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FMF 2007-09-21

POWRSYRINGE INJECTOR

Applicant Pinyons Medical Technology, Inc.

K number K072318

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FMF 2007-08-23

SMALL VOLUME SYRINGE

Applicant Alcon Laboratories

K number K062865

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FMF 2007-08-16

B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES

Applicant B.Braun Medical, Inc.

K number K071459

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FMF 2007-08-16

CRYOSEAL FS APPLICATOR SYSTEM

Applicant Thermogenesis Corp.

K number K071126

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FMF 2007-07-20

TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE

Applicant Tribofilm Research, Inc.

K number K071027

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FMF 2007-07-16

WELMED HYPODERMIC SYRINGE

Applicant Welmed, Inc.

K number K070936

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FMF 2007-07-11

TERUMO 31G THINPRO INSULIN SYRINGE

Applicant Terumo Medical Corp.

K number K071630

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FMF 2007-06-20

FEEL-JECT INSULIN SYRINGE

Applicant Feel Tech

K number K070917

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FMF 2007-06-05

GENIE, MODEL CH-200

Applicant Icu Medical, Inc.

K number K070633

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FMF 2007-05-30

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP

Applicant Confluent Surgical,Inc

K number K070814

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FMF 2007-05-29

EVICEL APPLICATION DEVICE

Applicant Omrix Biopharmaceuticals , Ltd.

K number K070575

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FMF 2007-05-29

50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB

Applicant Terumo Europe N.V.

K number K070264

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FMF 2007-05-24

TEXIUM SYRINGE

Applicant Cardinal Health, Alaris Products

K number K071108

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FMF 2007-03-21

HASELMEIER PEN

Applicant Haselmeier Sarl

K number K070100

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FMF 2007-03-01

TOP FINE INSULIN SYRINGE

Applicant Daejin Tech Medical Manufacturing Co., Ltd.

K number K063348

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FMF 2007-02-26

CAPTION APPLICATOR

Applicant Smith & Nephew, Inc.

K number K063535

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FMF 2007-02-08

FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC

Applicant Surgimed, Inc.

K number K062753

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FMF 2007-01-26

AUTO-FILL SYRINGE KIT, MODEL 7600

Applicant Vascular Solutions, Inc.

K number K063851

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FMF 2006-12-26

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE

Applicant Terumo Medical Corp.

K number K063613

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FMF 2006-12-08

MEDTRONIC GRAFT DELIVERY SYRINGE

Applicant Medtronic Sofamor Danek USA, Inc.

K number K062986

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FMF 2006-11-29

ULTICARE DISPOSABLE SYRINGES AND NEEDLES

Applicant Ultimed, Inc.

K number K062702

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FMF 2006-11-17

INJEKT SYRINGE

Applicant B.Braun Medical, Inc.

K number K063280

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FMF 2006-10-26

OSTEOBOOST-BMA

Applicant Orthos Limited

K number K062260

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FMF 2006-09-29

ARTHREX ASPIRATE KIT

Applicant Arthrex, Inc.

K number K062365

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FMF 2006-09-13

BAXTER DUPLOSPRAY MIS APPLICATOR

Applicant Micromedics, Inc.

K number K061092

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FMF 2006-08-23

MODIFICATION TO BONE GRAFT SYRINGE

Applicant Wrightmedicaltechnologyinc

K number K062173

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FMF 2006-08-03

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE

Applicant Tyco Healthcare

K number K061492

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FMF 2006-07-19

MEDLINE SYRINGES, MULTIPLE

Applicant Medline Industries, Inc.

K number K061275

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FMF 2006-06-29

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE

Applicant Amsino International, Inc.

K number K061039

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FMF 2006-06-01

CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093

Applicant Confluent Surgical,Inc

K number K061183

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FMF 2006-04-07

HUMAPEN MEMOIR

Applicant Eli Lilly and Company

K number K053563

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FMF 2006-04-06

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES

Applicant Terumo Europe N.V.

K number K053413

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FMF 2006-02-10

WUZHOU SYRINGE, WITH/WITHOUT NEEDLE

Applicant Wenzhou Wuzhou Group Co. , Ltd.

K number K060211

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FMF 2006-02-10

MODIFICATION TO: VACLOK SYRINGE

Applicant Wrightmedicaltechnologyinc

K number K060095

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FMF 2006-01-24

B. BRAUN 0.2 MICRON FILTER

Applicant B.Braun Medical, Inc.

K number K052773

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FMF 2005-11-25

ARTSANA PISTON AND INSULIN SYRINGES

Applicant Artsana S.P.A

K number K052667

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FMF 2005-11-09

PROCEDUR-10

Applicant Avanca Medical Devices, Inc.

K number K052075

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FMF 2005-10-19

VITAGEL SURGICAL HEMOSTAT SPRAY SET

Applicant Orthovita, Inc.

K number K052173

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FMF 2005-09-30

DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

Applicant Devon Safety Products, Inc.

K number K052551

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FMF 2005-09-02

YI XIN STERILE SYRINGE FOR SINGLE USE

Applicant Jiangxi Sanxin (Eversincere) Medical Devices Group

K number K050999

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FMF 2005-08-26

NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

Applicant Nipro Medical Corp.

K number K051574

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FMF 2005-08-16

TERUMO SYRINGE WITH/WITHOUT NEEDLE

Applicant Terumo Medical Corp.

K number K052034

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FMF 2005-08-16

DRUG ACCESS SPIKE

Applicant Medegen Medical Manufacturing Services

K number K051930

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FMF 2005-07-25

SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE

Applicant Synthes (Usa)

K number K051720

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FMF 2005-06-15

CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063

Applicant Confluent Surgical,Inc

K number K050998

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FMF 2005-05-18

STRYKER DISCMONITOR

Applicant Stryker Instruments

K number K050753

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FMF 2005-05-02

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)

Applicant Baxter Healthcare Corp., Bioscience

K number K050495

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FMF 2005-03-11

HARVEST GRAFT DELIVERY SYRINGE

Applicant Harvest Technologies, Corp.

K number K043261

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FMF 2005-02-22

DUOPROSS SYRINGES

Applicant Duopross Meditech Corporation

K number K042500

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FMF 2005-01-21

PROCEDUR 10 SYRINGE DEVICE

Applicant Avanca Medical Devices, Inc.

K number K042486

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FMF 2005-01-07

TRUGRAFT BGS SYRINGE, MODEL 600-041

Applicant Osteobiologics, Inc.

K number K043172

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FMF 2004-12-09

CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093

Applicant Confluent Surgical,Inc

K number K042588

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FMF 2004-12-01

DRAGON HEART PISTON SYRINGE

Applicant Dragon Heart Medical Devices Co., Ltd.

K number K042547

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FMF 2004-11-22

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE

Applicant Biogen

K number K042314

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FMF 2004-10-28

1BD SOLOSHOT IX SYRINGE

Applicant Becton, Dickinson & CO

K number K042934

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FMF 2004-10-04

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR

Applicant Micromedics, Inc.

K number K033589

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FMF 2004-09-29

MAGELLAN RATIO DISPENSER KIT

Applicant Medtronic Perfusion Systems

K number K041830

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FMF 2004-09-16

ASPIREX - BONE MARROW ASPIRATE KIT

Applicant Isotis Orthobiologics, Inc.

K number K041991

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FMF 2004-08-23

SMITH & NEPHEW GRAFT DELIVERY SYSTEM

Applicant Smith & Nephew, Inc.

K number K041976

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FMF 2004-08-06

HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01

Applicant Haemacure Corp.

K number K041504

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FMF 2004-07-16

OPEN BORE SYRINGE

Applicant Isotis NV

K number K041344

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FMF 2004-07-15

CLIP-ON SPACER 20%; 40%; 50%

Applicant Serono, Inc.

K number K041084

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FMF 2004-07-12

PHYSICIAN INDUSTRIES' DURAMETER SYRINGE

Applicant Physician Industries, Inc.

K number K033739

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FMF 2004-06-23

AUTODETECT SYRINGE

Applicant Indigo Orb, Inc.

K number K041590

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