FDA Product Code
FDA Product Code MEG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 162 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | 2026-02-18 | Traditional | PDF ↗ |
| K250847 | VaporShield | Vault Paragon Group, Inc. | 2025-12-12 | Traditional | PDF ↗ |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023-10-27 | Traditional | PDF ↗ |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | 2023-10-18 | Traditional | PDF ↗ |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC | 2023-06-21 | Abbreviated | PDF ↗ |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | 2023-01-25 | Traditional | PDF ↗ |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022-12-29 | Traditional | PDF ↗ |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 | Traditional | PDF ↗ |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 | Traditional | PDF ↗ |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022-08-23 | Traditional | PDF ↗ |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022-08-18 | Special | PDF ↗ |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | 2022-04-27 | Traditional | PDF ↗ |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2022-03-04 | Traditional | PDF ↗ |
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | 2022-03-02 | Traditional | PDF ↗ |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-03-01 | Traditional | PDF ↗ |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use | Henan Nursecare Biotechnology Co., Ltd. | 2022-02-24 | Abbreviated | PDF ↗ |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-02-15 | Traditional | PDF ↗ |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021-11-15 | Traditional | PDF ↗ |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-10-18 | Traditional | PDF ↗ |
| K211753 | Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-10-14 | Traditional | PDF ↗ |
| K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | Zhuhai DR Medical Instruments Co., Ltd. | 2021-09-29 | Traditional | PDF ↗ |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | 2020-09-11 | Traditional | PDF ↗ |
| K193022 | Retractable Safety Insulin Syringe | Jiangsu Caina Medical Co.,Ltd | 2020-07-20 | Traditional | PDF ↗ |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | 2020-04-10 | Traditional | PDF ↗ |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2019-10-04 | Traditional | PDF ↗ |
| K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe | Jiangsu Caina Medical Co.,Ltd | 2019-10-03 | Traditional | PDF ↗ |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | Jiangsu Micsafe Medical Technology Co., Ltd. | 2019-09-06 | Traditional | PDF ↗ |
| K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | 2019-01-28 | Traditional | PDF ↗ |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | Berpu Medical Technology Co., Ltd. | 2018-08-09 | Traditional | PDF ↗ |
| K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Yangzhou Medline Industry, Co., Ltd. | 2017-08-02 | Traditional | PDF ↗ |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 | Traditional | PDF ↗ |
| K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | 2017-02-02 | Special | PDF ↗ |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | 2016-08-19 | Special | PDF ↗ |
| K152606 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2016-06-28 | Traditional | PDF ↗ |
| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016-03-25 | Traditional | PDF ↗ |
| K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015-11-04 | Traditional | PDF ↗ |
| K143070 | Disposable Safety Self-destructive Syringes, 5 ML | Jiangsu Yile Medical Article Co., Ltd. | 2015-07-07 | Traditional | PDF ↗ |
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | 2015-06-02 | Abbreviated | PDF ↗ |
| K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 2015-04-10 | Traditional | PDF ↗ |
| K142435 | 3S Safety Syringe with/without Needle | Sincere Medical Device Co., Ltd. | 2015-02-20 | Traditional | PDF ↗ |
| K142436 | 3S Safety Insulin Syringe | Sincere Medical Device Co., Ltd. | 2015-02-19 | Traditional | PDF ↗ |
| K140949 | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE | Ultimed Incorporated | 2015-02-09 | Traditional | PDF ↗ |
| K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | Shantou Wealy Medical Instrument Co.,Ltd | 2014-11-19 | Traditional | PDF ↗ |
| K141664 | SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION | Rexam Healthcare | 2014-10-02 | Abbreviated | PDF ↗ |
| K141464 | NOVAGUARD S A SAFETY SYSTEM | West Pharmaceutical Services | 2014-09-10 | Traditional | PDF ↗ |
| K132681 | SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE | Sol-Millennium Medical, Inc. | 2014-05-22 | Traditional | PDF ↗ |
| K131531 | TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE | Anhui Tiankang Medical Products Co., Ltd. | 2014-05-12 | Traditional | PDF ↗ |
| K123743 | ULTRASAFE PLUS PASSIVE NEEDLE GUARD | Safety Syringes, Inc. | 2013-03-26 | Traditional | PDF ↗ |
| K121637 | AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE | Sunwell Biotech Co., Ltd. | 2012-10-25 | Traditional | PDF ↗ |
| K120641 | GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE | Global Medi Products | 2012-10-17 | Traditional | PDF ↗ |
| K122558 | ULTRASAFE PASSIVE NEEDLE GUARD | Safety Syringes, Inc. | 2012-09-20 | Special | PDF ↗ |
| K113587 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) | Shantou Wealy Medical Instrument Co.,Ltd | 2012-02-24 | Traditional | PDF ↗ |
| K112936 | SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM | Rexam Consummer Plastics Inc.D/B/A Rexam Pharma | 2012-01-20 | Abbreviated | PDF ↗ |
| K111734 | MYSAFETY SYRINGE | Medicalchain Intl. Corp. | 2011-09-06 | Special | PDF ↗ |
| K101560 | MEDLINE RETRACTABLE SAFETY SYRINGE | Medline Industries, Inc. | 2011-03-25 | Abbreviated | PDF ↗ |
| K101233 | SAFE'N'SOUND PASSIVE DELIVERY SYSTEM | Rexam Pharma | 2011-02-18 | Abbreviated | PDF ↗ |
| K103781 | MED-LOK SAFETY NEEDLE | Sta-Med, LLC | 2011-02-08 | Special | PDF ↗ |
| K103011 | ULTICARE SAFETY INSULIN SYRINGE | Ulti-Med Intl., Inc. | 2011-02-02 | Traditional | PDF ↗ |
| K100998 | 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 | Unilife Medical Solutions Limited | 2010-08-30 | Traditional | PDF ↗ |
| K093176 | MED-LOK | Sta-Med, LLC | 2010-04-06 | Traditional | PDF ↗ |
| K092413 | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES | Inviro Medical Devices, Inc. | 2009-09-04 | Special | PDF ↗ |
| K092430 | 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES | Inviro Medical Devices, Inc. | 2009-09-04 | Special | PDF ↗ |
| K080877 | 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 | Unilife Medical Solutions Limited | 2008-10-21 | Abbreviated | PDF ↗ |
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | Ultimed, Inc. | 2008-06-25 | Traditional | PDF ↗ |
| K072739 | JIERUI SYRINGES AND NEEDLES | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-03-21 | Traditional | PDF ↗ |
| K073206 | NEEDLE-TRAP/NEEDLE SAFETY LABEL | Schreiner Medipharm | 2008-01-16 | Traditional | PDF ↗ |
| K072482 | HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY | Smiths Medical Asd, Inc. | 2007-11-29 | Traditional | PDF ↗ |
| K072037 | CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML | Life-Shield Products, Inc. | 2007-08-08 | Special | PDF ↗ |
| K070117 | SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC | Dolomite Biotech Sdn Bhd | 2007-08-06 | Traditional | PDF ↗ |
| K070203 | INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 | Inviro Medical Devices, Inc. | 2007-04-23 | Special | PDF ↗ |
| K063340 | SAF-T-SYRINGE- 0.5 AND 1ML/CC | Safety Medical International, Incorporated | 2007-03-06 | Traditional | PDF ↗ |
| K063755 | PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE | Smiths Medical Asd, Inc. | 2007-02-27 | Traditional | PDF ↗ |
| K062780 | CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE | Medical Device Manufacturer (Thailand) , Ltd. | 2007-01-05 | Abbreviated | PDF ↗ |
| K062318 | BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML | Biotop Technology Co., Ltd. | 2007-01-03 | Traditional | PDF ↗ |
| K060971 | OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS | Omi Manufacturing Pty., Ltd. | 2006-10-24 | Traditional | PDF ↗ |
| K060772 | MANUEL SAFTEY SYRINGE PARTS 1 & 2 | Medsafe Asa | 2006-10-16 | Traditional | PDF ↗ |
| K061194 | PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 | Smiths Medical Asd, Inc. | 2006-08-24 | Abbreviated | PDF ↗ |
| K053519 | SAFETY SYRINGE | Wuxi Yushou Medical Applicances Co., Ltd. | 2006-08-11 | Traditional | PDF ↗ |
| K061055 | CAREO SAFETY SYRINGE FOR U-100 INSULIN | Life-Shield Products, Inc. | 2006-07-10 | Abbreviated | PDF ↗ |
| K060668 | SAFE TIP SYRINGE | Devon Safety Products, Inc. | 2006-06-12 | Traditional | PDF ↗ |
| K060002 | RITRACT SAFETY SYRINGE | Ritract , Ltd. | 2006-06-02 | Traditional | PDF ↗ |
| K060109 | OMI RETRACTABLE SAFETY SYRINGE | Vitalcare Group, Inc. | 2006-05-05 | Traditional | PDF ↗ |
| K060743 | MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) | Safety Syringes, Inc. | 2006-04-28 | Traditional | PDF ↗ |
| K060208 | CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, | Life-Shield Products, Inc. | 2006-03-10 | Special | PDF ↗ |
| K052397 | CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) | Life-Shield Products, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K051694 | CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE | Medical Device Manufacturer (Thailand) , Ltd. | 2005-12-21 | Abbreviated | PDF ↗ |
| K051800 | IN6 SAFETY SYRINGE, MODEL 3ML | In6 Incuvestor, Inc. | 2005-10-21 | Abbreviated | PDF ↗ |
| K052103 | EXEL SECURE TOUCH II SAFETY SYRINGE | Exelint Intl. Co. | 2005-10-19 | Traditional | PDF ↗ |
| K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | Terumo Medical Corp. | 2005-09-27 | Traditional | PDF ↗ |
| K051762 | SAF-T-SYRINGE/SAF-T-NEEDLE | Safety Medical International, Incorporated | 2005-09-23 | Traditional | PDF ↗ |
| K050116 | UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES | Uniqsafe Biomeditech Co., Ltd. | 2005-05-09 | Traditional | PDF ↗ |
| K043419 | P&P SAFETY SYRINGE | Medexel Medical Mfg. Co., Ltd. | 2005-04-15 | Traditional | PDF ↗ |
| K050131 | INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE | M.K. Meditech Co. , Ltd. | 2005-04-05 | Traditional | PDF ↗ |
| K050134 | ICC INSULIN SAFEPRO SAFETY SYRINGE | Formosa Medical Devices, Inc. | 2005-04-05 | Abbreviated | PDF ↗ |
| K042102 | YIXIN SAFETY SYRINGE | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005-03-08 | Traditional | PDF ↗ |
| K042487 | PROCEDUR SF SAFETY SYRINGE DEVICE | Avanca Medical Devices, Inc. | 2005-01-21 | Traditional | PDF ↗ |
Product code MEG · Class II · General Hospital. Data: openFDA.