| Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) (K260933) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 |
| Profoject™ Dual-Safety Pen Needles (K261829) | CMT Health PTE., Ltd. | 2026-07-29 |
| Profoject™ Pen Needles (Model A; Model B) (K260739) | CMT Health PTE., Ltd. | 2026-07-15 |
| Profoject™ Safety Pen Needles (K260855) | CMT Health PTE., Ltd. | 2026-06-10 |
| Verisafe Safety Sterile Needles (SSN) (K254273) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (K252908) | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| PRESSONE™ (K253047) | Nipro Medical Corporation | 2026-03-24 |
| Safety Pen Needle (K253622) | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| Pen Needle (K252886) | Hh Global Technology, Inc. | 2026-01-06 |
| Pen Injector Needle 32.5 (K250700) | Terumo Corporation | 2025-11-21 |
| Profoject™ Disposable Needle (K252631) | CMT Health PTE., Ltd. | 2025-10-16 |
| Intraosseous Infusion Needles (K250724) | Spectrum Vascular | 2025-07-30 |
| TSK SELECT™ Needle (K250284) | Tsk Laboratory, Japan | 2025-07-24 |
| K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (K251447) | Terumo Europe N.V. | 2025-07-08 |
| 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (K243309) | Terumo Europe N.V. | 2025-05-29 |
| FROG (Filter Removal of Glass) (K240355) | Carrtech Corp | 2025-04-18 |
| K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (K243581) | Terumo Europe N.V. | 2025-04-04 |
| SureFine Pen Needle (K250658) | Shina Med Corporation | 2025-04-03 |
| Safety Winged Blood Collection Sets (K243806) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 |
| ACE Cannula (K242741) | Ace Medical Industry Co., Ltd. | 2025-01-08 |
| Verifine® Pen Needles (K242632) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 |
| ZIEN IO Intraosseous Access System (K240915) | Zien Medical Technologies, Inc. | 2024-07-02 |
| Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles (K232165) | Berpu Medical Technology Co., Ltd. | 2024-02-01 |
| Sterile Hypodermic Needles for Single Use (K233037) | Zhejiang Kindly Medical Device Co., Ltd. | 2023-12-12 |
| SteriCap Safety Needle; VitreJect Safety Needle (K233343) | Ocuject, LLC | 2023-11-27 |
| MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® (K230070) | Promamedical, Inc. | 2023-10-05 |
| Insulin Pen Needle (K230043) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 |
| VitreJect® Needle; OcuSafe® Needle (K230959) | Ocuject, LLC | 2023-09-14 |
| Sterile Hypodermic Needles for Single Use (K231720) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| Sterile syringes for single use with/without needle (K231729) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| Sterile Safety Hypodermic Needles for Single Use (K231723) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| NovoFine® Plus (K231255) | Novo Nordisk, Inc. | 2023-08-25 |
| Altaviz Needle Kit II (K231261) | Altaviz, LLC | 2023-07-27 |
| EZ-IO Intraosseous Vascular Access System (K231924) | Teleflex Medical | 2023-07-25 |
| Pen Needle (K230635) | Jiangsu Caina Medical Co.,Ltd | 2023-06-02 |
| Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (K222852) | Nipro Medical Corporation | 2023-05-25 |
| Disposable Insulin Pen Needle (K222739) | Hantech Medical Device Co., Ltd. | 2023-04-06 |
| Shina Safety Needle (K222417) | Shina Corporation | 2023-03-20 |
| Sterile Aesthetic Cannula and Hypodermic Needle (K223327) | Shanghai Kindly Enterprise Development Group Co., Ltd. | 2023-02-16 |
| Verisafe Safety sterile needles (K222271) | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-15 |
| Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle (K203792) | Pikdare Spa | 2023-01-20 |
| BD AutoShield Duo™ Pen Needle (K223286) | Becton, Dickinson and Company | 2022-12-28 |
| Sterile Hypodermic Needles for Single Use (K223334) | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-12-16 |
| CCBIO ASCPO Needle (K214004) | Cc Biotechnology Corporation | 2022-12-13 |
| Altaviz Needle Kit (K222681) | Altaviz, LLC | 2022-12-05 |
| DropSafeTM SicuraTM (K223353) | Pikdare Spa | 2022-12-02 |
| Disposable Insulin Pen Needle (K221178) | Ningbo Medsun Medical Co., Ltd. | 2022-11-17 |
| Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle (K222124) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-11-04 |
| IO Needle Safety Sheath (K220890) | Actuated Medical, Inc. | 2022-10-31 |
| Safety Insulin Pen Needles (K213183) | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-10-14 |
| Sterile Safety Hypodermic Needles for Single Use (K221080) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| Sterile Hypodermic Needles for Single Use (K221066) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| Promisemed X-Safety Pen Needle (K220129) | Promisemed Hangzhou Meditech Co., Ltd. | 2022-09-19 |
| Disposable Medical Safety Hypodermic Needle (K220603) | Hantech Medical Device Co., Ltd. | 2022-08-23 |
| SurGuard3 Safety Hypodermic Needle (K212095) | Terumo Europe N.V. | 2022-08-22 |
| Insulin Pen Needle (K221176) | Tianjin Huahong Technology Co., Ltd. | 2022-07-01 |
| BD Pen Needle (K213478) | Becton, Dickinson and Company | 2022-06-28 |
| MEDOJECT fine Pen Needles (K220614) | Chirana T. Injecta | 2022-06-15 |
| Well-life TM Pen Needles, Well-life TM Safety Pen Needles (K210748) | W. L. Med Co., Ltd. | 2022-05-25 |
| Sterile Safety Hypodermic Needles for Single Use (K213535) | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-05-13 |
| Safety Pen Needle for Single Use, Insulin Pen Needles (K212514) | Berpu Medical Technology Co., Ltd. | 2022-04-29 |
| Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (K214075) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-04-12 |
| Safety Pen Needle (K210864) | Sandstone Medical (Suzhou), Inc. | 2022-02-17 |
| DropSafe Safety Pen Needles (K211716) | Htl Strefa SA | 2022-01-07 |
| UltiCare Disposable Pen Needles (K213407) | Ultimed Incorporated | 2021-12-16 |
| Blood Collection Needles (K200932) | Vacutest Kima Srl | 2021-12-14 |
| BD Nano 2nd Gen Pen Needle (K213156) | Becton, Dickinson and Company | 2021-12-08 |
| BD Nano 2nd Gen Pen Needle (K212015) | Becton, Dickinson and Company | 2021-11-19 |
| Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319) | Tianjin Huahong Technology Co., Ltd. | 2021-11-12 |
| Sterile Hypodermic Needles for Single Use (K211214) | Azur Medical Company, Inc. | 2021-10-14 |
| SteriCap Mini Needle and Standard Needles (K212805) | Ocuject, LLC | 2021-09-30 |
| Sterile Hypodermic Needles for Single Use (K210232) | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-23 |
| Unifine SafeControl (K210399) | Owen Mumford, Ltd. | 2021-09-17 |
| Hypodermic Needle-Pro EDGE Safety Device (K211634) | Smiths Medical Asd, Inc. | 2021-08-26 |
| NIO-I (K211395) | Einstein Works, LLC | 2021-07-28 |
| NIO+ Adult (K211968) | Waismed, Ltd. | 2021-07-22 |
| Promisemed Insulin Pen Needle (K210059) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-07-21 |
| Safety Winged Blood Collection Sets (K211293) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-06-25 |
| NovoFine (K210258) | Novo Nordisk, Inc. | 2021-06-23 |
| Verifine Safety Type Insulin Pen Needle (K210065) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-04-22 |
| EZ-IO Intraosseous Vascular Access System (K202492) | Teleflex Medical | 2021-03-22 |
| Easydrip Pen Needle, Easydrip Plus Pen Needle (K193422) | Sandstone Medical (Suzhou), Inc. | 2021-02-02 |
| Promisemed Covered Safety Pen Needle (K202681) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 |
| NovoFine Plus 32G Tip x 4 mm (K202005) | Novo Nordisk, Inc. | 2020-12-19 |
| Promisemed Triple Safety Pen Needle (K202682) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-11-24 |
| Eclipse DermaFlex Cannula (K200017) | Eclipse Medcorp, LLC | 2020-11-05 |
| Droplet Pen Needle 30G & 33G (K202340) | Htl-Strefa S.A | 2020-10-15 |
| Injection Pen Needle (K192464) | Gangan Medical Technology Jiangsu Co., Ltd. | 2020-08-25 |
| TK Safety Needle (K191644) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-06 |
| EZ-Inject Single use Needle (K192222) | Poonglim Pharmatech, Inc. | 2020-05-12 |
| Droplet Pen Needle 34G (K192082) | Htl-Strefa S.A | 2020-04-21 |
| Bella-mu (K190962) | U-Needle B.V. | 2020-02-03 |
| TK Sterile Hypodermic Needle (K191643) | Anhui Tiankang Medical Technology Co., Ltd. | 2019-12-19 |
| SAM IO Intraosseous Access System (K191488) | Sam® Medical Products, Inc. | 2019-11-21 |
| Piper GO-IO Intraosseous Infusion System (K191976) | Piper Access, LLC | 2019-11-13 |
| Intraosseous infusion device (K191258) | Einstein Works, LLC | 2019-10-23 |
| K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (K192057) | Terumo Europe N.V. | 2019-10-11 |
| NIO-I (K190538) | Waismed, Ltd. | 2019-10-07 |
| Dual-Safety Pen Needle (K191853) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-09-05 |
| SteriCap Mini Needle (K183016) | Ocujet, LLC | 2019-05-07 |