| 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 |
| Huahong Sharps Container (HHR-I, HHR-II) (K260845) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 |
| OMNI Ultra Surgical System (1-110) (K253760) | Sight Sciences, Inc. | 2026-08-04 |
| Profoject™ Dual-Safety Pen Needles (K261829) | CMT Health PTE., Ltd. | 2026-07-29 |
| Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326) | Datex-Ohmeda, Inc. | 2026-07-28 |
| RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703) | Deka R&D Corp | 2026-07-24 |
| PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves (K262014) | O&M Halyard, Inc. | 2026-07-21 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue (K254285) | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| Profoject™ Pen Needles (Model A; Model B) (K260739) | CMT Health PTE., Ltd. | 2026-07-15 |
| Ultra-Fine™ SAFETY Insulin Syringe (K260208) | embecta Medical II, LLC | 2026-07-13 |
| ClearSafe Closed System (K261041) | MedSource Labs, LLC | 2026-07-10 |
| MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539) | MedSource Labs, LLC | 2026-07-09 |
| HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology (K261897) | O&M Halyard, Inc. | 2026-07-02 |
| Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (K253527) | Covidien, LLC | 2026-07-01 |
| AMSCO 700 Steam Sterilizer (K261055) | STERIS Corporation | 2026-06-24 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (K252117) | Sw Technologies, Inc. | 2026-06-24 |
| Powder Free Nitrile Examination Gloves Non-Sterile Black (K253824) | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (K253110) | Sol-Millennium Medical, Inc. | 2026-06-18 |
| SteriBest® Sterilization Tray System (K253187) | Mastel Surgical | 2026-06-18 |
| InstaTRU Instant Biological Indicator for Steam (IBI-05) (K251559) | True Indicating, LLC | 2026-06-18 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) (K260867) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| FLEXI-PORT™ Power Injectable Implantable Port (K260916) | Portal Access, Inc. | 2026-06-17 |
| MEDRAD® Imaging Bulk Package Transfer Spike (K253688) | Bayer Medical Care, Inc. | 2026-06-12 |
| Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (K260514) | CMT Health PTE., Ltd. | 2026-06-12 |
| ADRx™ Admixture Device (K252987) | Epic Medical Pte. , Ltd. | 2026-06-12 |
| Profoject™ Safety Pen Needles (K260855) | CMT Health PTE., Ltd. | 2026-06-10 |
| Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) (K253162) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| Vial Adapter (K260301) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
| Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl (K260703) | S&S Glove Corporation | 2026-06-03 |
| Straumann® ProClean™ Cassette (041.800 ; 041.801) (K260726) | Institut Straumann AG | 2026-06-03 |
| Nitrile Disposable Examination Gloves (K260806) | Vista Industries,, LLC | 2026-06-03 |
| SteriTite Container System with MediTray Products (K252854) | Case Medical, Inc. | 2026-06-03 |
| iiSure Infusion Set (K261530) | Deka Research and Development | 2026-06-03 |
| Dukal Crepe Paper Sterilization Wrap (K252823) | Dukal, LLC | 2026-05-28 |
| Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong (K253773) | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026-05-22 |
| Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K253112) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap (K253454) | O&M Halyard, Inc. | 2026-05-18 |
| Introcan Safety® Deep Access XL IV Catheter (K253235) | B.Braun Medical, Inc. | 2026-05-15 |
| AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) (K252543) | Amsino International, Inc. | 2026-05-04 |
| Prolystica Pass Thru Disinfectant Wipes (DEN240075) | Steris | 2026-05-01 |
| Bayesian Health Sepsis Flagging Device (K250680) | Bayesian Health, Inc. | 2026-04-30 |
| Paptizer 360 (K252471) | LiViliti Health Products Corporation | 2026-04-29 |
| SMARTeZ™ Elastomeric Infusion Pump (RS series) (K250234) | Epic Medical Pte. , Ltd. | 2026-04-24 |
| °M Warmer System with °M Station (K260988) | Mequ A/S | 2026-04-24 |
| Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) (K252306) | Steritec Products | 2026-04-22 |
| Luminoah FLOW™ Enteral Nutrition System (K253558) | Luminoah | 2026-04-20 |
| Neonav ECG Tip Location System (K260929) | Navi Medical Technologies | 2026-04-17 |
| Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279) | Chirana T.Injecta,A.S. | 2026-04-17 |
| Verisafe Safety Sterile Needles (SSN) (K254273) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| STERRAD 100NX Sterilization System with ALLClear Technology (10104) (K252843) | Advanced Sterilization Products, Inc. | 2026-04-15 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K252757) | Cequr SA | 2026-04-10 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K251666) | STERIS Corporation | 2026-04-08 |
| Pivot Insulin Delivery System (K253534) | Modular Medical | 2026-04-08 |
| Celerity 5 HP Biological Indicator (LCB052) (K260766) | STERIS Corporation | 2026-04-08 |
| Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (K260860) | Basic Medical Technology, Inc. | 2026-04-07 |
| LifeShield Infusion Safety Software Suite (K252130) | Icu Medical, Inc. | 2026-04-02 |
| BD Insyte™ IV Catheter (K252137) | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 |
| Disposable Infusion Bag for Parenteral Nutrition (K252079) | Beijing L&Z Medical Technology Development Co., Ltd. | 2026-04-02 |
| Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513) | Poly Medicure Limited | 2026-04-01 |
| OTTO™ Disinfecting Cap (K252006) | Icu Medical, Inc. | 2026-03-27 |
| 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 |
| ClaveQS™ Bag (K251980) | Icu Medical, Inc. | 2026-03-20 |
| Safety Pen Needle (K253622) | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| SurgiCount+ System (K252282) | Stryker Instruments | 2026-03-16 |
| CORIS System (K253267) | Nanosonics Limited | 2026-03-05 |
| PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (K253791) | DePuy Mitek, Inc. | 2026-02-26 |
| Enbio PRO (K260254) | Enbio Group AG | 2026-02-26 |
| BD Surgiphor™ Antimicrobial Irrigation System (910110) (K253996) | Becton, Dickinson and Company (BD) | 2026-02-25 |
| Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068) | CMT Health PTE., Ltd. | 2026-02-23 |
| BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (K253445) | Bd | 2026-02-20 |
| LF Process Indicator Tape for Steam Sterilization (K260181) | Intertape Polymer Group | 2026-02-20 |
| Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (K252814) | CMT Health PTE., Ltd. | 2026-02-19 |
| PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (K252098) | Methyl Co., Ltd. | 2026-02-18 |
| Babyleo TN500 (K251619) | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| PuraCath Firefly Needleless Connector IT (9005) (K251375) | Puracath Medical, Inc. | 2026-02-12 |
| SteriHub™ Disinfecting Device and Protective Cover (K251592) | 1World Vista Medical | 2026-02-11 |
| Stainless Steel Surgical Kits (K251614) | Dentsply Sirona, Inc. | 2026-02-06 |
| Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (K250983) | Asistan Medikal | 2026-01-30 |
| UV Smart D60 (K251354) | UV Smart Technologies B.V. | 2026-01-29 |
| Sterilization Pouch/Roll (K251347) | Sterivic Medical Co., Ltd. | 2026-01-28 |
| FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015) | Koru Medical Systems, Inc. | 2026-01-28 |
| Syntex Exam Gloves (K253160) | Basic Medical Technology, Inc. | 2026-01-23 |
| Getinge GSS67N Series Steam Sterilizer (K252307) | Maquet GmbH (A Getinge Group Company) | 2026-01-22 |
| SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308) | Thera B Medical Products | 2026-01-15 |
| Cardinal Health Nitrile Examination Gloves Extended Cuff (K252313) | Cardinalhealth | 2026-01-14 |
| Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (K252549) | Kossan International Sdn Bhd | 2026-01-13 |
| KabiHelp® Uno; KabiHelp® Advance plus (K251139) | Fresenius Kabi AG | 2026-01-09 |
| Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (K251160) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 |
| Pen Needle (K252886) | Hh Global Technology, Inc. | 2026-01-06 |
| Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (K250168) | Lucas Lifecare | 2025-12-30 |
| SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (K251991) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 |
| QIKCAP System (DEN250004) | Hai Solutions | 2025-12-23 |
| Tetra (TM-20); Tetra (TM-50) (K251105) | Emed Technologies Corporation | 2025-12-22 |
| Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (K253222) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025-12-22 |
| Instylla Delivery Kit (K253769) | Instylla, Inc. | 2025-12-22 |
| Midline Catheter (K252402) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 |
| SURFLO Hybria Closed System Safety IV Catheter (K252398) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 |
| DuoprossTM Smart Cap (Type I) (K252518) | Duopross Meditech Corporate | 2025-12-17 |
| BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (K252373) | Spectrum Vascular | 2025-12-16 |