| YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (K250878) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K250630) | Basic Medical Technology, Inc. | 2025-05-22 |
| Ruby Intravascular Catheter (K243105) | Venocare, Inc. | 2025-05-16 |
| Promisemed Safety Huber Needles (K251138) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 |
| Aesculap Aicon® Series Container System (K242762) | Aesculap, Inc. | 2025-05-13 |
| Tristel OPH (K242732) | Tristel Solutions , Ltd. | 2025-05-09 |
| SteadiSet Infusion Set (K242692) | Capillary Biomedical, LLC | 2025-05-09 |
| Altaviz Intravitreal Syringe (K243322) | Altaviz, LLC | 2025-05-09 |
| Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048) | STERIS Corporation | 2025-05-02 |
| JetCan® Pro Safety Huber Needle (K242763) | Pfm Medical, Inc. | 2025-05-02 |
| OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (K250292) | Skydance Vascular, Inc. | 2025-05-02 |
| ONE TRAY® Sealed Sterilization Container System (K250029) | Innovative Sterilization Technologies | 2025-05-01 |
| Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (K250069) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 |
| Qitexio® 4-Way Stopcock (QIT014) (K242255) | Medex | 2025-04-29 |
| Self Sealing Sterilization Pouches (K243721) | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 |
| Infrared Thermometer (K243082) | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| BD Alaris Infusion System with Guardrails Suite MX (K243855) | Carefusion 303, Inc. | 2025-04-25 |
| VERIFY STEAM Integrating Indicator (K243876) | STERIS Corporation | 2025-04-25 |
| GO-PEN® (K250262) | Go-Pen Aps | 2025-04-24 |
| Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (K250944) | Gmp Medicare Sdn. Bhd. | 2025-04-23 |
| DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459) | Technoflex Sas. | 2025-04-18 |
| FROG (Filter Removal of Glass) (K240355) | Carrtech Corp | 2025-04-18 |
| STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802) | Advanced Sterilization Products, Inc. | 2025-04-14 |
| CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (K242429) | Becton Dickinson Inc. (Bd) | 2025-04-09 |
| Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (K243027) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (K250011) | Turbett Surgical | 2025-04-04 |
| K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (K243581) | Terumo Europe N.V. | 2025-04-04 |
| Prapela SVS hospital bassinet pad (model P01) (DEN240031) | Prapela, Inc. | 2025-04-04 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K243936) | Staclear, Inc. | 2025-04-03 |
| SureFine Pen Needle (K250658) | Shina Med Corporation | 2025-04-03 |
| LifeShield Infusion Safety Software Suite (K242117) | Icu Medical, Inc. | 2025-04-02 |
| Plum Solo™ Precision IV Pump (K242114) | Icu Medical, Inc. | 2025-04-02 |
| Plum Duo™ Precision IV Pump (K242115) | Icu Medical, Inc. | 2025-04-02 |
| Small Volume 0.2mL Syringe (K250138) | Prosum Medical Limited | 2025-04-02 |
| Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (K250578) | Careglove Global Sdn. Bhd. | 2025-04-01 |
| Synthes Graphic Case & Tray System (K241927) | Synthes GmbH | 2025-03-28 |
| MallyaD injection pen adapter (MallyaD) (K250555) | Biocorp Production | 2025-03-27 |
| HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (K244059) | Access Vascular, Inc. | 2025-03-27 |
| Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (K242564) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761) | Yukon Medical, LLC | 2025-03-21 |
| CORIS System (DEN240018) | Nanosonics Limited | 2025-03-19 |
| SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (K250502) | Safesource Direct, LLC | 2025-03-19 |
| Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242533) | Better Care Plastic Technology Co., Ltd. | 2025-03-18 |
| Promisemed Safety Huber Needles (K243332) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 |
| Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (K243599) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 |
| Solution Administration Sets (K243529) | Baxter Healthcare Corporation | 2025-03-14 |
| AION TempShield™ (K250401) | Aion Biosystems, Inc. | 2025-03-14 |
| RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357) | Deka Research & Development Corp. | 2025-03-11 |
| da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596) | Intuitive Surgical, Inc. | 2025-03-10 |
| FRONT-LINE Field Sterilizer (FL135) (K243801) | Fort Defiance Industries, LLC | 2025-03-07 |
| Intravascular Extension Sets and Accessories (K242339) | Baxter Healthcare Corporation | 2025-02-28 |
| pilot TLS (K241587) | Vygon Corporation | 2025-02-26 |
| Sterilization Package/Reel (K241565) | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 |
| Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (K243959) | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 |
| Medicom Sterilization Pouch and Reel (K243431) | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
| Sterilization Pouches and Reels (K242898) | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 |
| Green Card Bowie-Dick Test (BD115) (K250172) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 |
| Microdent Sterilization Cassette (K242023) | Implant Microdent System S.L.U. | 2025-02-19 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) (K243792) | Basic Medical Technology, Inc. | 2025-02-18 |
| VIA360™ Surgical System (K243503) | New World Medical, Inc. | 2025-02-14 |
| Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) (K243136) | Shenzhen Finicare Co., Ltd. | 2025-02-14 |
| Body Temperature Software (BTS) (K243778) | Fitbit, LLC | 2025-02-13 |
| NUVENTUS NV.C™ Surgical Cassette and Tray (K243317) | Infinitum Eta, Ltd. | 2025-02-11 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034) | Ever Global (Vietnam) Enterprise Corporation | 2025-02-06 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K250044) | STERIS Corporation | 2025-02-06 |
| Celerity Incubator (K250061) | STERIS Corporation | 2025-02-06 |
| GraftGun Universal Graft Delivery System (GDS) (K243580) | SurGenTec, LLC | 2025-02-05 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (K243441) | Basic Medical Technology, Inc. | 2025-01-31 |
| 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K243501) | 3M Company | 2025-01-28 |
| ZeroClear™ Bag Access (423100) (K243976) | Epic Medical Pte. , Ltd. | 2025-01-22 |
| Rio™ Drug Reconstitution Transfer Device (K243985) | Icu Medical, Inc. | 2025-01-22 |
| Neonav ECG Tip Location System (K241910) | Navi Medical Technologies | 2025-01-19 |
| HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (K243941) | Access Vascular, Inc. | 2025-01-17 |
| Babyroo TN300 (K243606) | Draeger Medical Systems, Inc. | 2025-01-17 |
| Type 5 Integrating Indicator for Steam (CSPN-15) (K242860) | True Indicating, LLC | 2025-01-17 |
| Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736) | Deka Research and Development Corp. | 2025-01-16 |
| System 9 Sterile Battery Container (K242834) | Stryker Instruments | 2025-01-16 |
| Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936) | Sunray Medical Products, Inc. | 2025-01-15 |
| 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 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K243818) | Hartalega NGC Sdn. Bhd. | 2025-01-08 |
| ProSeal™ Vented Universal Vial Adaptor (K240517) | Epic Medical Pte. , Ltd. | 2024-12-26 |
| Insulin Syringes (K242434) | Chirana T. Injecta | 2024-12-24 |
| Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735) | Belmont Medical Technologies | 2024-12-23 |
| Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K241856) | Hlb Lifescience Co., Ltd. | 2024-12-23 |
| Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (K242281) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024-12-20 |
| Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (K243149) | Congruence Medical Solutions, LLC | 2024-12-20 |
| Lyka® PORT Needle Free Access Device (4170Y) (K241058) | Quest Medical, Inc. | 2024-12-18 |
| Klockner Kits (K243128) | SOADCO, S.L. | 2024-12-18 |
| Autoclave Indicator Tape; EO Indicator Tape (K241036) | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 |
| Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K242558) | O&M Halyard, Inc. | 2024-12-17 |
| Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (K242453) | Terragene S.A. | 2024-12-12 |
| SmartSiteTM Vented Vial Access Device (K243486) | Yukon Medical, LLC | 2024-12-06 |
| Chemical Indicator for enspire CLCSPS (LCC015) (K243475) | STERIS Corporation | 2024-12-04 |
| GripMate (K243232) | Synthon Hispania S.L. | 2024-12-02 |
| SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (K241115) | Spectrum Vascular | 2024-11-27 |
| Remunity System (K243354) | Deka Research & Development Corp. | 2024-11-27 |
| PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (K241353) | Bard Access Systems, Inc. | 2024-11-27 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K242538) | 3M Company | 2024-11-25 |
| SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (K242291) | Sol-Millennium Medical, Inc. | 2024-11-20 |