FDA Product Code
FDA Product Code FMF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 752 records · page 4 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051720 | SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE | Synthes (Usa) | 2005-07-25 | Traditional | PDF ↗ |
| K050998 | CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 | Confluent Surgical,Inc | 2005-06-15 | Traditional | PDF ↗ |
| K050753 | STRYKER DISCMONITOR | Stryker Instruments | 2005-05-18 | Traditional | PDF ↗ |
| K050495 | EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) | Baxter Healthcare Corp., Bioscience | 2005-05-02 | Special | PDF ↗ |
| K043261 | HARVEST GRAFT DELIVERY SYRINGE | Harvest Technologies, Corp. | 2005-03-11 | Traditional | PDF ↗ |
| K042500 | DUOPROSS SYRINGES | Duopross Meditech Corporation | 2005-02-22 | Traditional | PDF ↗ |
| K042486 | PROCEDUR 10 SYRINGE DEVICE | Avanca Medical Devices, Inc. | 2005-01-21 | Traditional | PDF ↗ |
| K043172 | TRUGRAFT BGS SYRINGE, MODEL 600-041 | Osteobiologics, Inc. | 2005-01-07 | Traditional | PDF ↗ |
| K042588 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 | Confluent Surgical,Inc | 2004-12-09 | Traditional | PDF ↗ |
| K042547 | DRAGON HEART PISTON SYRINGE | Dragon Heart Medical Devices Co., Ltd. | 2004-12-01 | Abbreviated | PDF ↗ |
| K042314 | SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE | Biogen | 2004-11-22 | Traditional | PDF ↗ |
| K042934 | 1BD SOLOSHOT IX SYRINGE | Becton, Dickinson & CO | 2004-10-28 | Special | PDF ↗ |
| K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR | Micromedics, Inc. | 2004-10-04 | Traditional | PDF ↗ |
| K041830 | MAGELLAN RATIO DISPENSER KIT | Medtronic Perfusion Systems | 2004-09-29 | Traditional | PDF ↗ |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | Isotis Orthobiologics, Inc. | 2004-09-16 | Abbreviated | PDF ↗ |
| K041976 | SMITH & NEPHEW GRAFT DELIVERY SYSTEM | Smith & Nephew, Inc. | 2004-08-23 | Traditional | PDF ↗ |
| K041504 | HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 | Haemacure Corp. | 2004-08-06 | Traditional | PDF ↗ |
| K041344 | OPEN BORE SYRINGE | Isotis NV | 2004-07-16 | Abbreviated | PDF ↗ |
| K041084 | CLIP-ON SPACER 20%; 40%; 50% | Serono, Inc. | 2004-07-15 | Traditional | PDF ↗ |
| K033739 | PHYSICIAN INDUSTRIES' DURAMETER SYRINGE | Physician Industries, Inc. | 2004-07-12 | Traditional | PDF ↗ |
| K041590 | AUTODETECT SYRINGE | Indigo Orb, Inc. | 2004-06-23 | Traditional | PDF ↗ |
| K033721 | VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT | Vascular Solutions, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | Ultimed, Inc. | 2003-12-30 | Special | PDF ↗ |
| K033166 | KACEY INSULIN SYRINGE | Kacey, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| K030683 | NIPRO DISPOSABLE SYRINGES | Nipro Medical Corp. | 2003-10-31 | Traditional | PDF ↗ |
| K031394 | AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE | American Syringe Company | 2003-07-25 | Traditional | PDF ↗ |
| K021993 | SHANCHUAN SYRINGE | Shangdong Zibo Shanchuan Medical Instruments Co. | 2003-06-03 | Traditional | PDF ↗ |
| K030208 | IMBIBE II SYRINGE | Orthovita, Inc. | 2003-04-16 | Traditional | PDF ↗ |
| K023074 | IMBIBE BONE MARROW ASPIRATION SYRINGE | Orthovita, Inc. | 2003-03-11 | Special | PDF ↗ |
| K024052 | MERIT MEDICAL 1-ML SYRINGE | Merit Medical Systems, Inc. | 2003-02-21 | Abbreviated | PDF ↗ |
| K023752 | BD INTEGRA SYRINGE | Bd | 2003-02-07 | Traditional | PDF ↗ |
| K024112 | BD INSULIN SYRINGE | Becton, Dickinson & CO | 2003-01-09 | Special | PDF ↗ |
| K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2002-12-18 | Abbreviated | PDF ↗ |
| K023108 | STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE | Atlantic Products, Inc. | 2002-12-03 | Traditional | PDF ↗ |
| K022159 | PISTON SYRINGE & HYPODERMIC NEEDLE | International Medsurg Connection | 2002-11-07 | Traditional | PDF ↗ |
| K022495 | GETTIG DISPOSABLE SYRINGES | Gettig Pharmaceutical Instrument Co. | 2002-10-08 | Traditional | PDF ↗ |
| K023088 | BONE GRAFT SYRINGE, MODEL 8600-00X0 | Wrightmedicaltechnologyinc | 2002-10-02 | Traditional | PDF ↗ |
| K022246 | MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | 2002-08-02 | Special | PDF ↗ |
| K021084 | LIGHT SABER SPINAL NEEDLE | Minrad, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K021071 | PCCS GRAFT DELIVERY SYSTEM | Biomet, Inc. | 2002-07-01 | Traditional | PDF ↗ |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | Nipro Diabetes Systems, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K020666 | DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002-06-24 | Abbreviated | PDF ↗ |
| K014088 | DUPLOREACH | Baxter Healthcare Corp | 2002-06-07 | Traditional | PDF ↗ |
| K021197 | SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 | Hosuk Co., Ltd. | 2002-04-26 | Special | PDF ↗ |
| K020252 | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 | Harvest Technologies, Corp. | 2002-04-05 | Traditional | PDF ↗ |
| K020147 | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP | Medtronic Perfusion Systems | 2002-04-03 | Traditional | PDF ↗ |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Portex, Inc. | 2002-02-13 | Traditional | PDF ↗ |
| K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR | Micromedics, Inc. | 2001-10-29 | Traditional | PDF ↗ |
| K011087 | ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE | Orthovita, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K011176 | REUSABLE GLASS SYRINGES | Lockett Medical Corp. | 2001-08-10 | Traditional | PDF ↗ |
| K011951 | EZ SYRINGE | Owen Mumford, Ltd. | 2001-08-02 | Traditional | PDF ↗ |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | Spintech, Inc. | 2001-06-29 | Traditional | PDF ↗ |
| K010708 | APPLICATOR TIP/DUAL SPRAYER KIT | Interpore Cross Intl. | 2001-04-30 | Traditional | PDF ↗ |
| K010890 | BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) | Becton, Dickinson and Co. | 2001-04-19 | Special | PDF ↗ |
| K010359 | INNOVO | Novo Nordisk A/S | 2001-03-14 | Traditional | PDF ↗ |
| K003571 | SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE | Terumo Medical Corp. | 2001-02-12 | Abbreviated | PDF ↗ |
| K002381 | PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES | Pentaferte, S.R.L. | 2001-01-11 | Traditional | PDF ↗ |
| K002717 | STERILE PISTON SYRINGE | Abbott Laboratories | 2001-01-08 | Traditional | PDF ↗ |
| K002127 | INJECTRITE-C15 AND INJECTRITE-C30 | Sterling Medivations, Inc. | 2000-12-29 | Abbreviated | PDF ↗ |
| K002569 | GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES | Malgam Ent., Inc. | 2000-12-12 | Traditional | PDF ↗ |
| K003193 | DUPLOGRIP | Baxter Healthcare Corp | 2000-11-07 | Special | PDF ↗ |
| K002921 | SUREONE INSULIN SYRINGE | Hosuk Co., Ltd. | 2000-10-18 | Traditional | PDF ↗ |
| K001731 | AVID-NIT LOSS OF RESISTANCE SYRINGE | Avid Medical, Inc. | 2000-08-29 | Traditional | PDF ↗ |
| K981089 | TISSOMAT AND SPRAY SET | Baxter Healthcare Corp | 2000-07-05 | Traditional | PDF ↗ |
| K001474 | TERUMO U-100 INSULIN SYRING | Terumo Medical Corp. | 2000-06-09 | Special | PDF ↗ |
| K000747 | UNIVEC TWO PIECE SYRINGE | Univec, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K992404 | THE WAND | Spintech, Inc. | 2000-06-06 | Traditional | PDF ↗ |
| K000456 | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 | Harvest Technologies, LLC | 2000-06-01 | Traditional | PDF ↗ |
| K000438 | MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER | Biosurgical Corp. | 2000-05-03 | Traditional | PDF ↗ |
| K994023 | HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 | Haemacure Corp. | 2000-04-25 | Traditional | PDF ↗ |
| K994230 | ULTICARE DISPOSABLE SYRINGE | Ultimed, Inc. | 2000-03-24 | Traditional | PDF ↗ |
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | Shinchang Medical Co., Ltd. | 2000-02-25 | Traditional | PDF ↗ |
| K993995 | VEIN ENTRY INDICATOR DEVICE (VEID) | Vascular Technologies , Ltd. | 2000-02-14 | Traditional | PDF ↗ |
| K000144 | NIPRO INSULIN SYRINGE | Nipro Medical Corp. | 2000-02-11 | Traditional | PDF ↗ |
| K000048 | SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 | Biosurgical Corp. | 2000-01-31 | Special | PDF ↗ |
| K994253 | VACLOK SYRINGE | Merit Medical Systems, Inc. | 2000-01-05 | Special | PDF ↗ |
| K993666 | DISETRONIC PEN P100 | Disetronic Medical Systems | 1999-11-22 | Special | PDF ↗ |
| K992351 | SEALOUETTE FIBRIN SEALANT APPLICATOR | Biosurgical Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K992802 | TERUMO U-100 INSULIN SYRINGE | Terumo Medical Corp. | 1999-09-09 | Special | PDF ↗ |
| K991225 | MTI 1 ML SYRINGE | Micro Therapeutics, Inc. | 1999-07-08 | Abbreviated | PDF ↗ |
| K990020 | TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC | Te ME NA S.A.R.L. | 1999-06-24 | Traditional | PDF ↗ |
| K991758 | MONOJECT INSULIN SYRINGE | The Kendal Co. | 1999-06-14 | Abbreviated | PDF ↗ |
| K991039 | EASYSAFE RETRACTING NEEDLE SYRINGE | Saf-T-Med, Inc. | 1999-05-21 | Traditional | PDF ↗ |
| K984017 | ALLISON MEDICAL INSULIN SYRINGE (AMIS) | Allison Medical, Inc. | 1999-03-04 | Traditional | PDF ↗ |
| K983430 | LITE-TOUCH SYRINGE | Medicore, Inc. | 1999-02-09 | Traditional | PDF ↗ |
| K983994 | UNIFINE | Owen Mumford USA, Inc. | 1999-01-08 | Traditional | PDF ↗ |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | Owen Mumford USA, Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K982966 | DISETRONIC PEN | Disetronic Medical Systems | 1998-10-19 | Traditional | PDF ↗ |
| K980078 | PENETREASE | P.T. Panca Pusaka Deli | 1998-10-16 | Traditional | PDF ↗ |
| K982842 | HUMAPEN AND HUMAPEN ERGO | Eli Lilly and Co. | 1998-09-25 | Traditional | PDF ↗ |
| K982018 | LIGHT SABER ASPIRATION NEEDLE | Minrad, Inc. | 1998-08-07 | Traditional | PDF ↗ |
| K972728 | STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-07-15 | Traditional | PDF ↗ |
| K981140 | MINRAD DRTS LIGHT SABER SYRINGE | Minrad, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K980580 | BECTON DICKINSON SYRINGES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-25 | Traditional | PDF ↗ |
| K981797 | B-D PEN ULTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-12 | Traditional | PDF ↗ |
| K980987 | BECTON DICKINSON SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-11 | Traditional | PDF ↗ |
| K963364 | GLASS VAN GLASS SYRINGES | Myco Medical Supplies, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K980796 | TERUMO ALLERGY SYRINGE | Terumo Corp. | 1998-04-02 | Traditional | PDF ↗ |
| K980755 | B-D E ML PEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-04-02 | Traditional | PDF ↗ |
| K980181 | TERUMO DISPOSABLE HYPODERMC SYRINGE | Terumo Medical Corp. | 1998-04-02 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.