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 3 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K121283 | BD EMERALD SAF-T SINGLE USE, HYPODERMIC | Becton, Dickinson and Company | 2012-05-30 | Special | PDF ↗ |
| K121124 | ARTHREX MIXING AND DELIVERY SYSTEM | Arthrex, Inc. | 2012-05-16 | Traditional | PDF ↗ |
| K111841 | SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. | 2012-03-01 | Traditional | PDF ↗ |
| K112057 | KDL SYRINGES AND NEEDLE | Shanghai Kindly Enterprise Dev. Group Co., | 2011-12-14 | Traditional | PDF ↗ |
| K113241 | BD EMERALD SINGLE USE, HYPODERMIC SYRINGE | Becton Dickinson | 2011-11-28 | Special | PDF ↗ |
| K112475 | XTRACT SYRINGE KEY SYSTEM | Xtract Solutions | 2011-11-10 | Traditional | PDF ↗ |
| K110882 | IMC INSULIN SYRINGE | International Medsurg Connection | 2011-08-18 | Traditional | PDF ↗ |
| K111632 | INFILL GRAFT DELIVERY SYSTEM | Pinnacle Spine Group, LLC | 2011-08-11 | Traditional | PDF ↗ |
| K103830 | JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) | Jiangsu Shenli Medical Production Factory | 2011-07-29 | Abbreviated | PDF ↗ |
| K110697 | TIGER SYRINGES AND NEEDLES | Tiger Medical Products, Ltd. | 2011-07-14 | Traditional | PDF ↗ |
| K111091 | MERIT MEDICAL 20 ML SYRINGE | Merit Medical Systems, Inc. | 2011-06-24 | Special | PDF ↗ |
| K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | Dmc Medical, Ltd. | 2011-06-10 | Traditional | PDF ↗ |
| K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | Becton, Dickinson and Company | 2011-05-13 | Special | PDF ↗ |
| K110421 | DISPOSABLE INSULIN SYRINGE | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011-04-26 | Traditional | PDF ↗ |
| K110112 | CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE | Rongshan LI | 2011-04-20 | Traditional | PDF ↗ |
| K103200 | PROPEP DELIVERY DEVICE | Rhythmlink International, LLC | 2011-04-12 | Traditional | PDF ↗ |
| K101708 | PATIENT SAFE LUER CAP | Retractable Technologies, Inc. | 2011-02-24 | Traditional | PDF ↗ |
| K102192 | INDISCAL DIGITAL MANOMETER | Baylis Medical Co., Inc. | 2011-02-23 | Traditional | PDF ↗ |
| K102969 | IMC PISTON SYRINGES | International Medsurg Connection | 2010-12-20 | Special | PDF ↗ |
| K101547 | HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) | Henke-Sass, Wolf GmbH | 2010-11-22 | Traditional | PDF ↗ |
| K102178 | EASY TOUCH | Mhc Medical Products | 2010-09-02 | Special | PDF ↗ |
| K101359 | INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) | Inviro Medical Devices, Inc. | 2010-08-20 | Special | PDF ↗ |
| K100988 | HUMAPEN LUXURA HD | Eli Lilly and Company | 2010-08-17 | Traditional | PDF ↗ |
| K100665 | MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX | Needle Tech Products, Inc. | 2010-06-24 | Abbreviated | PDF ↗ |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | Micromedics, Inc. | 2010-06-09 | Traditional | PDF ↗ |
| K093863 | EPIDRUM | Exmoor Plastics , Ltd. | 2010-05-10 | Traditional | PDF ↗ |
| K093400 | 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 | Unilife Medical Solutions Limited | 2010-04-01 | Special | PDF ↗ |
| K091722 | COAXIAL APPLICATOR SYSTEM | Biomet, Inc. | 2010-03-12 | Traditional | PDF ↗ |
| K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO | Neomed, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K092986 | ACACIA PISTON SYRINGE | Acacia, Inc. | 2009-10-27 | Traditional | PDF ↗ |
| K091200 | XTRACT SYRINGE KEYS | Xtract Solutions, LLC | 2009-08-21 | Traditional | PDF ↗ |
| K091279 | NIPRO DISPOSABLE SYRINGE | Nipro Medical Corporation | 2009-08-12 | Special | PDF ↗ |
| K091167 | SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES | Shina Corp. | 2009-08-06 | Traditional | PDF ↗ |
| K091474 | EASY.TOUCH INSULIN SYRINGE | Masters Healthcare, LLC | 2009-07-09 | Traditional | PDF ↗ |
| K091377 | BD FLU+ SYRINGE | Becton, Dickinson & CO | 2009-07-02 | Traditional | PDF ↗ |
| K083686 | BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES | Anhui Kangda Medical Products Co., Ltd. | 2009-07-02 | Traditional | PDF ↗ |
| K083583 | XPRESSE INJECTION SYSTEM | Nordson Efd | 2009-06-30 | Traditional | PDF ↗ |
| K090929 | STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE | Shanghai Double Dove Industrial Co., Ltd. | 2009-06-12 | Traditional | PDF ↗ |
| K091315 | COVIDIEN EXTENDED TIP APPLICATOR | Confluent Surgical,Inc | 2009-06-05 | Special | PDF ↗ |
| K083514 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Europe N.V. | 2009-05-22 | Traditional | PDF ↗ |
| K090162 | EVICEL APPLICATION DEVICE | Omrix Biopharmaceuticals , Ltd. | 2009-02-20 | Special | PDF ↗ |
| K083193 | REVAC AUTO RETRACTABLE SAFETY SYRINGE | Revolutions Medical Corporation, Inc. | 2009-02-13 | Traditional | PDF ↗ |
| K083457 | TACTIPEN | Haselmeier GmbH | 2009-02-13 | Traditional | PDF ↗ |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | Spectra Medical Devices, Inc. | 2008-11-28 | Traditional | PDF ↗ |
| K082454 | MICROMYST APPLICATOR, MODEL 20-5000 | Covidien | 2008-11-07 | Traditional | PDF ↗ |
| K081436 | INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES | Inviro Medical Devices, Inc. | 2008-10-22 | Traditional | PDF ↗ |
| K082616 | HASELMEIER PEN 8 | Haselmeier GmbH | 2008-09-26 | Special | PDF ↗ |
| K081547 | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC | Bio-Med USA, Inc. | 2008-09-08 | Traditional | PDF ↗ |
| K081241 | WEIGAO EMPTY CARTRIDGE SYRINGE | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-09-08 | Traditional | PDF ↗ |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L | Spectra Medical Devices, Inc. | 2008-07-29 | Traditional | PDF ↗ |
| K080989 | UNIVERSAL VIAL ACCESS SPIKE | Icu Medical, Inc. | 2008-05-02 | Special | PDF ↗ |
| K072790 | CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 | Confluent Surgical,Inc | 2008-01-11 | Traditional | PDF ↗ |
| K072654 | PATIENT SAFE SYRINGE | Retractable Technologies, Inc. | 2007-12-14 | Traditional | PDF ↗ |
| K072330 | CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM | Biomet, Inc. | 2007-12-06 | Traditional | PDF ↗ |
| K070856 | ICU MEDICAL SINGLE-USE SYRINGE | Icu Medical, Inc. | 2007-10-05 | Abbreviated | PDF ↗ |
| K072299 | POWRSYRINGE ASPIRATOR | Pinyons Medical Technology, Inc. | 2007-10-04 | Traditional | PDF ↗ |
| K072345 | POWRSYRINGE MONITOR | Pinyons Medical Technology, Inc. | 2007-09-21 | Traditional | PDF ↗ |
| K072318 | POWRSYRINGE INJECTOR | Pinyons Medical Technology, Inc. | 2007-09-21 | Traditional | PDF ↗ |
| K062865 | SMALL VOLUME SYRINGE | Alcon Laboratories | 2007-08-23 | Traditional | PDF ↗ |
| K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | B.Braun Medical, Inc. | 2007-08-16 | Traditional | PDF ↗ |
| K071126 | CRYOSEAL FS APPLICATOR SYSTEM | Thermogenesis Corp. | 2007-08-16 | Traditional | PDF ↗ |
| K071027 | TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE | Tribofilm Research, Inc. | 2007-07-20 | Traditional | PDF ↗ |
| K070936 | WELMED HYPODERMIC SYRINGE | Welmed, Inc. | 2007-07-16 | Abbreviated | PDF ↗ |
| K071630 | TERUMO 31G THINPRO INSULIN SYRINGE | Terumo Medical Corp. | 2007-07-11 | Special | PDF ↗ |
| K070917 | FEEL-JECT INSULIN SYRINGE | Feel Tech | 2007-06-20 | Traditional | PDF ↗ |
| K070633 | GENIE, MODEL CH-200 | Icu Medical, Inc. | 2007-06-05 | Traditional | PDF ↗ |
| K070814 | MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP | Confluent Surgical,Inc | 2007-05-30 | Special | PDF ↗ |
| K070264 | 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB | Terumo Europe N.V. | 2007-05-29 | Traditional | PDF ↗ |
| K070575 | EVICEL APPLICATION DEVICE | Omrix Biopharmaceuticals , Ltd. | 2007-05-29 | Traditional | PDF ↗ |
| K071108 | TEXIUM SYRINGE | Cardinal Health, Alaris Products | 2007-05-24 | Traditional | PDF ↗ |
| K070100 | HASELMEIER PEN | Haselmeier Sarl | 2007-03-21 | Traditional | PDF ↗ |
| K063348 | TOP FINE INSULIN SYRINGE | Daejin Tech Medical Manufacturing Co., Ltd. | 2007-03-01 | Traditional | PDF ↗ |
| K063535 | CAPTION APPLICATOR | Smith & Nephew, Inc. | 2007-02-26 | Traditional | PDF ↗ |
| K062753 | FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC | Surgimed, Inc. | 2007-02-08 | Abbreviated | PDF ↗ |
| K063851 | AUTO-FILL SYRINGE KIT, MODEL 7600 | Vascular Solutions, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2006-12-26 | Special | PDF ↗ |
| K062986 | MEDTRONIC GRAFT DELIVERY SYRINGE | Medtronic Sofamor Danek USA, Inc. | 2006-12-08 | Traditional | PDF ↗ |
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | Ultimed, Inc. | 2006-11-29 | Traditional | PDF ↗ |
| K063280 | INJEKT SYRINGE | B.Braun Medical, Inc. | 2006-11-17 | Traditional | PDF ↗ |
| K062260 | OSTEOBOOST-BMA | Orthos Limited | 2006-10-26 | Traditional | PDF ↗ |
| K062365 | ARTHREX ASPIRATE KIT | Arthrex, Inc. | 2006-09-29 | Traditional | PDF ↗ |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | Micromedics, Inc. | 2006-09-13 | Traditional | PDF ↗ |
| K062173 | MODIFICATION TO BONE GRAFT SYRINGE | Wrightmedicaltechnologyinc | 2006-08-23 | Special | PDF ↗ |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | Tyco Healthcare | 2006-08-03 | Traditional | PDF ↗ |
| K061275 | MEDLINE SYRINGES, MULTIPLE | Medline Industries, Inc. | 2006-07-19 | Abbreviated | PDF ↗ |
| K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE | Amsino International, Inc. | 2006-06-29 | Traditional | PDF ↗ |
| K061183 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 | Confluent Surgical,Inc | 2006-06-01 | Special | PDF ↗ |
| K053563 | HUMAPEN MEMOIR | Eli Lilly and Company | 2006-04-07 | Traditional | PDF ↗ |
| K053413 | TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES | Terumo Europe N.V. | 2006-04-06 | Traditional | PDF ↗ |
| K060095 | MODIFICATION TO: VACLOK SYRINGE | Wrightmedicaltechnologyinc | 2006-02-10 | Special | PDF ↗ |
| K060211 | WUZHOU SYRINGE, WITH/WITHOUT NEEDLE | Wenzhou Wuzhou Group Co. , Ltd. | 2006-02-10 | Traditional | PDF ↗ |
| K052773 | B. BRAUN 0.2 MICRON FILTER | B.Braun Medical, Inc. | 2006-01-24 | Traditional | PDF ↗ |
| K052667 | ARTSANA PISTON AND INSULIN SYRINGES | Artsana S.P.A | 2005-11-25 | Abbreviated | PDF ↗ |
| K052075 | PROCEDUR-10 | Avanca Medical Devices, Inc. | 2005-11-09 | Special | PDF ↗ |
| K052173 | VITAGEL SURGICAL HEMOSTAT SPRAY SET | Orthovita, Inc. | 2005-10-19 | Traditional | PDF ↗ |
| K052551 | DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE | Devon Safety Products, Inc. | 2005-09-30 | Traditional | PDF ↗ |
| K050999 | YI XIN STERILE SYRINGE FOR SINGLE USE | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005-09-02 | Traditional | PDF ↗ |
| K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | Nipro Medical Corp. | 2005-08-26 | Traditional | PDF ↗ |
| K052034 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2005-08-16 | Special | PDF ↗ |
| K051930 | DRUG ACCESS SPIKE | Medegen Medical Manufacturing Services | 2005-08-16 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.