| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) (K232252) | Dehai (Shandong) Medical Gloves, Co., Ltd. | 2023-11-28 |
| T-Top 10 & T-Top T-Top 11 (K232658) | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 |
| SteriCap Safety Needle; VitreJect Safety Needle (K233343) | Ocuject, LLC | 2023-11-27 |
| SaviSafe Safety Device (K230287) | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 |
| Medical Nitrile Examination Gloves (K232576) | Jiangsu Complete Sincerity Medical New Materials Co., Ltd. | 2023-11-21 |
| DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL (K232538) | Wrp Asia Pacific Sdn. Bhd. | 2023-11-17 |
| Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis (K232461) | Kossan International Sdn Bhd | 2023-11-14 |
| Flush Syringe (Prefilled 0.9% normal saline solution) (K231724) | Spm Medicare Pvt. , Ltd. | 2023-11-09 |
| LILY Extension Tube and Needleless Connector (K222780) | Lily Medical Corporation | 2023-11-09 |
| Revital Cady (K231519) | Revital Healthcare (Epz) Limited | 2023-11-06 |
| ProSeal™ Closed System Administration Set (K230343) | Epic Medical Pte. , Ltd. | 2023-11-03 |
| Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter (K231918) | Koru Medical Systems | 2023-11-03 |
| Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266) | Better Care Plastic Technology Co., Ltd. | 2023-11-03 |
| EpiZact (K233056) | Guidestar Medical Devices | 2023-11-02 |
| SAFIRA (K230083) | Medovate Limited | 2023-10-31 |
| Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl (K231029) | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-30 |
| GIA™ Stapler with Tri-Staple™ Technology (K231934) | Covidien | 2023-10-27 |
| Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) (K233187) | Steris | 2023-10-27 |
| Shina Syringe; Shina Safety Syringe (K231165) | Shina Med Corporation | 2023-10-27 |
| Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs (K230662) | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-26 |
| Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set (K232205) | Vesco Medical, LLC | 2023-10-23 |
| V-PRO maX 2 Low Temperature Sterilization System (K233065) | Steris | 2023-10-20 |
| Nitrile Examination Gloves, Dual Color Black-Blue (K232550) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-10-20 |
| Terumo Injection Filter Needle (NF-3013RBKE05M) (K230951) | Terumo Europe N.V. | 2023-10-18 |
| Medline Safety Insulin and TB Syringes (K231907) | Medline Industries, LP | 2023-10-18 |
| Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) (K232128) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-10-14 |
| Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (K232070) | Better Care Plastic Technology Co., Ltd. | 2023-10-11 |
| Patient Examination Gloves (K230777) | 3A Glove Sdn. Bhd. | 2023-10-06 |
| Vial Adapter (K232055) | Shanghai Lingfu Technology Co., Ltd. | 2023-10-06 |
| Disposable Sterile Syringe (K221777) | Weihai Shengjie Medical Technology Co., Ltd. | 2023-10-06 |
| 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 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) (K231567) | Better Care Plastic Technology Co., Ltd. | 2023-10-04 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (K232914) | STERIS Corporation | 2023-10-03 |
| Orchid Safety Release ValveTM (K232094) | Linear Health Sciences, LLC | 2023-10-03 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl (K230681) | Central Medicare Sdn Bhd | 2023-10-02 |
| Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (K232064) | Isikel Manufacturing, LLC | 2023-10-02 |
| Chemotherapy Gloves (K230847) | 3A Glove Sdn. Bhd. | 2023-09-29 |
| SafeBreak® Vascular (K231957) | Lineus Medical | 2023-09-29 |
| VeriSafe Safety sterile syringes (K231792) | Promisemed Hangzhou Meditech Co., Ltd. | 2023-09-28 |
| Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (K231363) | Hantech Medical Device Co., Ltd. | 2023-09-27 |
| BD Texium™ Needle-Free Syringe (K231888) | Care Fusion | 2023-09-25 |
| CATHTONG™ II PICC Catheter (K232571) | L&Z Us, Inc. | 2023-09-22 |
| Nexiva™ Closed IV Catheter System with NearPort™ IV Access (K231239) | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-22 |
| CATHTONG™ II PICC Catheter (K232594) | L&Z Us, Inc. | 2023-09-22 |
| Powder-Free Nitrile Examination Gloves (K223214) | Global Protection Corp. | 2023-09-21 |
| Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401) | Poly Medicure Limited | 2023-09-21 |
| Insulin Pen Needle (K230043) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 |
| MA-40, MA-112 (K223835) | Medify Air, LLC | 2023-09-18 |
| The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788) | Medsource International, LLC | 2023-09-15 |
| PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860) | Poonglim Pharmatech, Inc. | 2023-09-15 |
| VitreJect® Needle; OcuSafe® Needle (K230959) | Ocuject, LLC | 2023-09-14 |
| PureWay 1.4 Quart Sharps Collector (K231484) | Pureway Compliance, Inc. | 2023-09-14 |
| AMSCO 600 Steam Sterilizer (K232485) | Steris | 2023-09-13 |
| VERIFY Spore Test Strip for S40 Sterilant Concentrate (K231746) | STERIS Corporation | 2023-09-11 |
| VitreJect Syringe (K230372) | Ocuject, LLC | 2023-09-08 |
| Sterile Hypodermic Needles for Single Use (K231720) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K231643) | Syntex Healthcare Products Co., Ltd. | 2023-09-08 |
| Sterile Auto-Disable Syringes with/without Needle for Single Use (K231727) | 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 |
| Steriking® LT-Blueline Pouches with Tyvek® (K231999) | Wipak OY | 2023-09-07 |
| Steriking® LT-Blueline Pouches with Tyvek® (K231996) | Wipak OY | 2023-09-07 |
| LightStrike+ (MXSUV1-SL and MXSUV1-FT) (DEN230007) | Xenex Disinfection Services, Inc. | 2023-09-01 |
| eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (K223674) | Epic Medical Pte. , Ltd. | 2023-09-01 |
| Powder Free Nitrile Examination Gloves (Black) (K232353) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-08-31 |
| OSPREY Closed IV Catheter System (OspreyV2) (K231626) | Skydance Vascular, Inc. | 2023-08-31 |
| KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K231435) | Kimberly-Clark Corporation | 2023-08-28 |
| Sterilization Wrap (K223600) | Wuhan Zonsen Medical Products Co., Ltd. | 2023-08-25 |
| NovoFine® Plus (K231255) | Novo Nordisk, Inc. | 2023-08-25 |
| OMNI Surgical System (K232214) | Sight Sciences, Inc. | 2023-08-25 |
| Reusable Temperature Probe, Disposable Temperature Probe (K223807) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 |
| Instrument Case (K231604) | Cochlear Americas | 2023-08-24 |
| Nitrile Patient Examination Gloves, Powder Free, Pink Color (K222103) | Shandong Yinghng Medical Products Co., Ltd. | 2023-08-24 |
| Plum Duo™ Infusion System (K223607) | Icu Medical, Inc. | 2023-08-24 |
| LifeShield™ Infusion Safety Software Suite (K223606) | Icu Medical, Inc. | 2023-08-24 |
| Celsi Monitor (K230298) | Hadleigh Health Technologies | 2023-08-16 |
| Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) (K230314) | New Era Medicare Sdn. Bhd. | 2023-08-16 |
| TA™ Stapler and Loading Unit with DST Series™ Technology (K231491) | Covidien | 2023-08-16 |
| EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil (K232126) | Covidien | 2023-08-16 |
| TK Pre-Filled Normal Saline Flush Syringe (K230756) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-12 |
| Pre-Filled Normal Saline Flush Syringe (K223584) | Anhui Tianyang Pharmaceutical Co., Ltd. | 2023-08-12 |
| Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile (K231408) | Shandong Intco Medical Products Co, Ltd. | 2023-08-11 |
| Powder Free White, Black, and Purple Nitrile Examination Glove (K231439) | S&S Glove Corporation | 2023-08-11 |
| Otsuka Digital Feedback Device-RW (K223463) | Otsuka America Pharmaceutical, Inc. | 2023-08-11 |
| Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232039) | Grand Work Plastic Products Co., Ltd. | 2023-08-09 |
| Disposable Medical Examination Nitrile Gloves (K232008) | Raxwell Industrial, LLC | 2023-08-08 |
| Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (K231490) | STERIS Corporation | 2023-08-07 |
| V-PRO maX 2 Low Temperature Sterilization System (K223476) | STERIS Corporation | 2023-08-07 |
| Vis-U-All Low Temperature Sterilization Pouches (K231500) | STERIS Corporation | 2023-08-07 |
| Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223713) | Better Care Plastic Technology Co., Ltd. | 2023-08-07 |
| PRO-LITE Sterilization Tray (K231501) | STERIS Corporation | 2023-08-07 |
| Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (K231488) | Steris | 2023-08-07 |
| iTEMPSHIELD (K232010) | Aion Biosystems, Inc. | 2023-08-04 |
| Chemfort® Catheter Adaptor (K231286) | Simplivia Healthcare , Ltd. | 2023-08-02 |
| Altaviz Needle Kit II (K231261) | Altaviz, LLC | 2023-07-27 |
| EZ-IO Intraosseous Vascular Access System (K231924) | Teleflex Medical | 2023-07-25 |
| A-TAP (previously called Arthrotap) (K231900) | Elcam Medical Acal | 2023-07-25 |
| Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl (K223752) | Central Medicare Sdn Bhd | 2023-07-24 |
| Three Way Stop Cock (K223499) | M/S Romsons International | 2023-07-21 |
| 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (K231161) | Becton, Dickinson and Company | 2023-07-21 |