| VaporShield (K250847) | Vault Paragon Group, Inc. | 2025-12-12 |
| EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089) | Exelint International, Co. | 2025-12-12 |
| Self-Seal Sterilization Pouch and Roll (K251177) | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 |
| Verisafe Safety Retractable Insulin Syringes (K250192) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| ProSeal™ Transfer Injector (421120, 421130, 421140) (K251722) | Epic Medical Pte. , Ltd. | 2025-12-05 |
| nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257) | Np Medical | 2025-12-04 |
| 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884) | Becton, Dickinson and Company | 2025-12-02 |
| K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (K252355) | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K251849) | Staclear, Inc. | 2025-11-21 |
| Pen Injector Needle 32.5 (K250700) | Terumo Corporation | 2025-11-21 |
| Fluido Compact System (K252636) | The Surgical Company International B.V. | 2025-11-18 |
| PM2™ System with ECGuide™ Connector (K252792) | Piccolo Medical, Inc. | 2025-11-17 |
| Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K251141) | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| Sterilization Trays (K251756) | Paragon Implant Mfg., LLC | 2025-11-14 |
| Biomoneta Avata Rx (K251872) | Biomoneta Research Private Limited | 2025-11-14 |
| Polyshield Safety IV Catheters (K252677) | Poly Medicure Limited | 2025-11-05 |
| Merit Syringe (K250853) | Merit Medical Systems, Inc. | 2025-11-04 |
| Chex-All Sterilization Pouches and Tubes (K250306) | Propper Manufacturing Co., Inc. | 2025-10-31 |
| BD Alaris Pump Infusion Set (K250325) | Carefusion (Bd) | 2025-10-30 |
| Disposable Vinyl Examination Gloves (K252467) | Viet Phu Trade and Import Export Co., Ltd. | 2025-10-27 |
| Medline Bag Decanter (K250345) | Medline Industries, LP | 2025-10-24 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (K250861) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663) | Datex-Ohmeda, Inc. | 2025-10-22 |
| Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (K253033) | Simplivia Healthcare , Ltd. | 2025-10-21 |
| Program insite® Powder-Free, Disposable Nitrile Exam Gloves (K252075) | Program Insite, LLC | 2025-10-17 |
| Profoject™ Disposable Needle (K252631) | CMT Health PTE., Ltd. | 2025-10-16 |
| Sure-Fine Insulin Syringes (K250510) | Shina Med Corporation | 2025-10-15 |
| PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (K251874) | Pureway Compliance, Inc. | 2025-10-14 |
| Community Containers (Flap and Daisy) (K252637) | Keter Canada, Inc. | 2025-10-14 |
| FlowArt® Vial Access Device Vented (K251715) | Asset Medikal | 2025-10-14 |
| SoClean 3+ (K243815) | Soclean, Inc. | 2025-10-10 |
| BD Saf-T-Intima™ Subcutaneous Catheter System (K251422) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-10-08 |
| Celerity™ 20 HP Biological Indicator (K252680) | STERIS Corporation | 2025-09-24 |
| Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (K251676) | Microtek Medical, LLC | 2025-09-16 |
| Zener® (model ZEN-001-B1) (K252128) | Uvx, Inc. | 2025-09-15 |
| BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (K250059) | Becton, Dickinson and Company | 2025-09-12 |
| Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (K252478) | Bard Access Systems, Inc. | 2025-09-05 |
| Fluido® AirGuard System (K251733) | The Surgical Company International BV (As Tsc Life) | 2025-09-04 |
| EZ™ IV Administration Set (K251814) | Epic Medical Pte. , Ltd. | 2025-08-29 |
| Powder-Free Vinyl Exam Gloves, clear (K252505) | Basic Medical Technology, Inc. | 2025-08-28 |
| SmartPilot YpsoMate NS-A2.25 (K243901) | Ypsomed AG | 2025-08-28 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716) | Basic Medical Technology, Inc. | 2025-08-27 |
| Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec (K243660) | Cardinalhealth | 2025-08-22 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid (K252244) | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (K243604) | O&M Halyard, Inc. | 2025-08-18 |
| Cassette Autoclave (ACA5) (K250164) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 |
| mOm Essential Incubator (ME1) (K243437) | Mom Incubators Limited | 2025-08-14 |
| SteadiSet infusion set (K251854) | Tandem Diabetes Care | 2025-08-06 |
| Chemfort Female Luer Lock Adaptor (K251411) | Simplivia Healthcare , Ltd. | 2025-08-05 |
| Terragene® Bionova® BT20 Biological Indicator (K251122) | Terragene | 2025-08-04 |
| eZSURE™ Empty Fluid Container (K252094) | Epic Medical Pte. , Ltd. | 2025-08-01 |
| Sparta Infusion Set for Insulin (K243841) | Deka Research and Development | 2025-08-01 |
| HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (K243458) | Access Vascular, Inc. | 2025-08-01 |
| Intraosseous Infusion Needles (K250724) | Spectrum Vascular | 2025-07-30 |
| TSK Syringe (K250127) | Tsk Laboratory, Japan | 2025-07-30 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff (K251319) | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| BD Plastipak™ Syringe (K251350) | Becton, Dickinson and Company | 2025-07-29 |
| SIGMA Spectrum Infusion Pump with Master Drug Library (K251640) | Baxter Healthcare Corporation | 2025-07-28 |
| Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) | Baxter Healthcare Corporation | 2025-07-28 |
| BD Nexiva™ Closed IV Catheter System (K243403) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 |
| Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033) | CMT Health PTE., Ltd. | 2025-07-25 |
| TSK SELECT™ Needle (K250284) | Tsk Laboratory, Japan | 2025-07-24 |
| Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392) | B.Braun Medical, Inc. | 2025-07-24 |
| Plastic Surgical Kits (K251300) | Dentsply Sirona, Inc. | 2025-07-22 |
| Guided DAS Surgical Kit (K243425) | Talladium España, SL | 2025-07-22 |
| HyHub™ and HyHub™ Duo Vial Access Devices (K243404) | Takeda Pharmaceuticals | 2025-07-18 |
| AEON™ Endoscopic Powered Stapler (K251482) | Lexington Medical, Inc. | 2025-07-11 |
| BD Cathena™ Safety IV Catheter (K251155) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 |
| Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (K250193) | Basic Medical Technology, Inc. | 2025-07-09 |
| Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (K250342) | Encompass Industries Sdn. Bhd. | 2025-07-08 |
| K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (K251447) | Terumo Europe N.V. | 2025-07-08 |
| Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) (K250496) | Zibo Shengkun Chemical Industry Co., Ltd. | 2025-07-07 |
| 3DOSE 1ml Syringe (K250733) | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (K251212) | Access Vascular, Inc. | 2025-07-01 |
| Otsuka Digital Feedback Device (K251088) | Otsuka America Pharmaceutical, Inc. | 2025-06-30 |
| BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 |
| Sterilization Pouch and Roll (K243179) | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 |
| GPS Advanced; GPS Advanced Cannula (K251648) | Prosidyan, Inc. | 2025-06-24 |
| Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (K250470) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (K243000) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (K243062) | Becton Dickinson | 2025-06-20 |
| PAL Sterilization Case (K243589) | Microaire Surgical Instruments, LLC | 2025-06-20 |
| PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253) | Bard Access Systems, Inc. | 2025-06-18 |
| Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (K243172) | O&M Halyard, Inc. | 2025-06-18 |
| Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K243133) | Kl-Kepong Rubber Products Sdn. Bhd. | 2025-06-17 |
| MallyaG Injection Pen Adapter (MallyaG) (K251500) | Biocorp Production | 2025-06-09 |
| Steam Sterilizer (2545D) (K243994) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K251452) | Steris | 2025-06-06 |
| GCI Sterilization Wrappers (K250321) | George Courey, Inc. | 2025-06-06 |
| Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (K243694) | Mah Sing Healthcare Sdn. Bhd. | 2025-06-06 |
| Clave™ Neutral-Displacement Needlefree Connectors (K250616) | Icu Medical, Inc. | 2025-06-05 |
| GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (K243796) | Glove One, LLC | 2025-06-03 |
| DISINTEK™ PA Test Strips (K251035) | Serim Research | 2025-06-03 |
| BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-03 |
| ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (K251340) | Epic Medical Pte. , Ltd. | 2025-05-29 |
| PM2+ System and SmartPICC Stylet (K243484) | Piccolo Medical, Inc. | 2025-05-29 |
| BiliWrap (K243372) | Gerium Medical, Ltd. | 2025-05-29 |
| 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (K243309) | Terumo Europe N.V. | 2025-05-29 |
| MRidium 3870 MRI Infusion Pump System (3870) (K242752) | Iradimed Corporation | 2025-05-28 |
| Helios+ UV-C System (K242604) | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |