| CerroZone Mini (K242102) | Cerrozone, LLC | 2024-11-19 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K243273) | Cequr SA | 2024-11-13 |
| VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (DEN230085) | Steris | 2024-11-12 |
| InfuLife (K240624) | First Medical Source, LLC | 2024-11-05 |
| CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (K240438) | Comercializadora Brever | 2024-11-04 |
| Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (K240881) | Covidien (Part of Medtronic) | 2024-11-01 |
| PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (K242328) | Bard Access Systems, Inc. | 2024-10-31 |
| Wearable Digital Thermometer (T31) (K240333) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| FMT Disposable and Autoclavable Temperature Probes (K240223) | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| Nitrile Powder Free Examination Gloves Biodegradable (Green) (K240269) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-10-25 |
| LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (K242956) | Ocuject, LLC | 2024-10-25 |
| STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (K242073) | Tsk Laboratory International Japan KK | 2024-10-23 |
| ProSeal™ Closed System Bag Access (K241988) | Epic Medical Pte. , Ltd. | 2024-10-23 |
| Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (K242099) | Sol-Millennium Medical, Inc. | 2024-10-22 |
| 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K241959) | 3M Company | 2024-10-18 |
| Safe Secure Sterilization Pouches and Rolls (K242839) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 |
| Getinge Assured MI Steam Migrating Integrator (K242795) | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 |
| NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (K242812) | Nb Medical Company Limited | 2024-10-12 |
| ProSeal™ In Line Pump Set (423850) (K241735) | Epic Medical Pte. , Ltd. | 2024-10-10 |
| PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K242208) | Primed Medical Products, Inc. | 2024-10-07 |
| SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (K242152) | Epic Medical Pte. , Ltd. | 2024-10-07 |
| DEKA Infusion System, DEKA Administration Set (K242693) | Deka Research and Development Corporation | 2024-10-07 |
| Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660) | Zevex, Inc. | 2024-10-03 |
| Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836) | Kem Medical Products Corporation | 2024-09-30 |
| Aulisa Temperature Module (TM0002) (K240220) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909) | O&M Halyard, Inc. | 2024-09-27 |
| TearRepair Liquid Skin Protectant (K241916) | Optmed, Inc. | 2024-09-27 |
| Verifine® Pen Needles (K242632) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 |
| Ecomed Disposable Administration Sets (K234129) | Ecomed Solutions, LLC | 2024-09-20 |
| Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821) | Sol-Millennium Medical, Inc. | 2024-09-20 |
| Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K231383) | Terragene S.A. | 2024-09-18 |
| LOWTEM Crystal 120 (K231893) | Lowtem Co., Ltd. | 2024-09-18 |
| Perpak™ Sterilization Tyvek Pouch (K241123) | Km Corp. | 2024-09-18 |
| Medline Reusable Sterilization Wrappers (K234132) | Medline Industries, LP | 2024-09-17 |
| HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050) | O&M Halyard, Inc. | 2024-09-16 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K241710) | 3M Company | 2024-09-12 |
| Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) (K241745) | Ksg Medicare Sdn. Bhd. | 2024-09-11 |
| Latex Examination Glove Powder Free (Ocean Blue and Natural White) (K240266) | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 |
| PM2 System and ECGuide Connector (K240486) | Piccolo Medical, Inc. | 2024-09-08 |
| nextaro® va, 15mm, 5µm (K241976) | Sfm Medical Devices GmbH | 2024-09-06 |
| Orchid Safety Release Valve™ (K241415) | Linear Health Sciences, LLC | 2024-09-06 |
| Novum IQ Syringe Pump (40800BAXUS) (K242390) | Baxter Healthcare Corporation | 2024-09-05 |
| Tamper Evident Cap (K231095) | International Medical Industries, Inc. | 2024-09-04 |
| Modular Medical MODD1 Insulin Delivery System (K240158) | Modular Medical, Inc. | 2024-09-04 |
| ToxiSeal™ Vial Adaptor (K241823) | Epic Medical Pte. , Ltd. | 2024-08-30 |
| GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (K240545) | Genabio Diagnostics, Inc. | 2024-08-28 |
| Chronos® (DEN230067) | Germitec | 2024-08-28 |
| Guided Surgery Kit Cases (K241492) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 |
| Cardinal Health Nitrile Exam Gloves (K241780) | Cardinal Health200, LLC | 2024-08-23 |
| INSULCLOCK® v2.0 PRO (K241803) | Insulcloud S.L. | 2024-08-22 |
| I.V. Administration Set (K242126) | Bq Plus Medical Co., Ltd. | 2024-08-22 |
| Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) (K240077) | Covidien | 2024-08-20 |
| CELERITY HP Indicator Tape (PCC077) (K242189) | Steris | 2024-08-20 |
| Disposable Pen Injector Assembly (K240961) | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 |
| SoClean 3+ Bacterial Reduction Device (DEN210037) | Soclean, Inc. | 2024-08-12 |
| HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) (K240330) | O&M Halyard, Inc. | 2024-08-07 |
| Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-08-06 |
| Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) (K241970) | Kanglongda Vietnam Protection Technology Company Limited | 2024-08-02 |
| ViroZap Indoor Air Purifier, In Duct Model 1008 (K241140) | Applied Photonix, LLC | 2024-08-01 |
| SteriTite rigid reusable sterilization container with MediTray Products (K240898) | Case Medical | 2024-07-31 |
| PowerGlide Pro™ Midline Catheter (K240359) | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024-07-29 |
| Introcan Safety® 2 IV Catheter (K241845) | B.Braun Medical, Inc. | 2024-07-26 |
| Vent Vial Adapter (K233287) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| CrossRoads Modular Tray System (K241050) | Crossroads Extremity Systems | 2024-07-16 |
| Omnifix Syringe NRFit (K241385) | B.Braun Medical, Inc. | 2024-07-13 |
| S.I.N. Instrument Kits (K241378) | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 |
| Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (DEN220042) | Terragene S.A. | 2024-07-12 |
| GPS Advanced; 5 cc GPS Advanced Cannula (K241426) | Prosidyan, Inc. | 2024-07-10 |
| STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (K234082) | Advanced Sterilization Products | 2024-07-05 |
| STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (K234084) | Advanced Sterilization Products, Inc. | 2024-07-05 |
| ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) (K241629) | Ethicon Endo-Surgery, LLC | 2024-07-03 |
| Extended Reservoir; MiniMed Reservoir (K241622) | Medtronic Minimed | 2024-07-02 |
| Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue (K240930) | Sri Trang Gloves Thailand (Public Company Limited) | 2024-07-02 |
| ZIEN IO Intraosseous Access System (K240915) | Zien Medical Technologies, Inc. | 2024-07-02 |
| 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (K241542) | 3M Company | 2024-06-27 |
| 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K240717) | 3M Company | 2024-06-27 |
| SteroScope® Sterilization Technology System (K233762) | Ideate Medical, Inc. | 2024-06-27 |
| Ultraphon Chemical Indicator (TRO-T and TRO-B) (K233413) | True Indicating, LLC | 2024-06-26 |
| FlowArt Valve for Vial Access (K232987) | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| Allograft Delivery Device (OFAC-C) (K233368) | Bioventus, LLC | 2024-06-25 |
| Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) (K240824) | Ningxia Qiaoen Medical Technology Co., Ltd. | 2024-06-25 |
| SteadyTemp (K233280) | Steadysense GmbH | 2024-06-21 |
| ToxiSeal™ Vial Adaptor with External Flip Balloon (K241476) | Epic Medical Pte. , Ltd. | 2024-06-21 |
| eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442) | Epic Medical Pte. , Ltd. | 2024-06-21 |
| PRESSUREALERT® Pressure Monitoring System (K233096) | Position Health, LLC | 2024-06-21 |
| Medicom Sterilization Wrap (K240862) | Medicom Group, Inc. | 2024-06-21 |
| Pen Injector (K240774) | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 |
| Airdog X8 Air Purifier (KJ800F-X8) (K240696) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 |
| Remunity System (K240256) | Deka Research and Development | 2024-06-12 |
| EO Chex Indicator Tape (K240910) | Propper Manufacturing Co., Inc. | 2024-06-12 |
| Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950) | Perfect Medical Industry (Vn) Co., Ltd. | 2024-06-12 |
| MetriCide™ OPA Plus Solution Test Strip (K241344) | Steris | 2024-06-11 |
| Steriking® Pouch for Robotic Instruments (K232625) | Wipak OY | 2024-06-07 |
| Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) (K240648) | Radiant Innovation, Inc. | 2024-06-05 |
| Perforated Baskets (K231291) | Richard Wolf Medical Instruments Corporation | 2024-06-03 |
| °M Warmer System (K232107) | Mequ A/S | 2024-05-31 |
| Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (K232943) | Smiths Medical Asd, Inc. | 2024-05-31 |
| PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K241190) | Poonglim Pharmatech, Inc. | 2024-05-29 |
| Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K240629) | Xingyu Medical Tech Co., Ltd. | 2024-05-28 |
| PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K233777) | Primed Medical Products, Inc. | 2024-05-24 |