| Hp Detect™ Stool Antigen ELISA (K232892) | Biomerica, Inc. | 2023-12-15 |
| Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K233042) | Shandong Intco Medical Products Co, Ltd. | 2023-12-06 |
| 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 |
| 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 |
| Aptima® Chlamydia trachomatis Assay (K230451) | Hologic, Inc. | 2023-11-16 |
| 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 |
| Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810) | Micro-Nx Co., Ltd. | 2023-11-09 |
| 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 |
| Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl (K231029) | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-30 |
| BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge (K232393) | Proedge Dental Products, Inc. | 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 |
| GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (K231902) | Ansell Healthcare | 2023-10-20 |
| Nitrile Examination Gloves, Dual Color Black-Blue (K232550) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-10-20 |
| 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 |
| 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 |
| YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) (K232230) | Zhenjiang Assure Medical Equipment Co., Ltd. | 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 |
| PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (K231973) | Ineo Tech Sdn Bhd | 2023-09-29 |
| Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638) | Cepheid | 2023-09-27 |
| High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (K220179) | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 |
| Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 |
| Powder-Free Nitrile Examination Gloves (K223214) | Global Protection Corp. | 2023-09-21 |
| Accuject Refra Injector AR2900 (K231106) | Medicel AG | 2023-09-19 |
| Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) (K232198) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) (K232199) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| ThermPix Thermovisual Camera (K232462) | Usa Therm, Inc. | 2023-09-14 |
| 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 |
| Minuteful-kidney test (K222921) | Healthy.Io, Ltd. | 2023-09-08 |
| Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL (K200583) | Ki Mobility, LLC | 2023-09-05 |
| InnerView LC (K232657) | Perimetrics, Inc. | 2023-09-01 |
| Powder Free Nitrile Examination Gloves (Black) (K232353) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-08-31 |
| Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K230578) | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 |
| Little Wave Arc; Little Wave Flip (K223533) | Ki Mobility, LLC | 2023-08-31 |
| Little Wave Clik, Rogue XP, Little Wave XP, Spark (K223527) | Ki Mobility, LLC | 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 |
| QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (K230221) | Versant Medical Physics and Radiation Safety | 2023-08-28 |
| Nitrile Patient Examination Gloves, Powder Free, Pink Color (K222103) | Shandong Yinghng Medical Products Co., Ltd. | 2023-08-24 |
| EVO 700 series high speed handpiece (K232243) | Ttbio Corp. | 2023-08-23 |
| Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (K230079) | Ansell Healthcare Products, LLC | 2023-08-23 |
| Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs (K222993) | Sentienx Sdn Bhd | 2023-08-18 |
| Powdered Free Sterile Natural Rubber Latex Surgical Gloves (K230832) | The Egyptian Company For Medical & Electronic Industries | 2023-08-16 |
| Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) (K230314) | New Era Medicare Sdn. Bhd. | 2023-08-16 |
| MA012 Aluminum wheelchair, MS019 steel wheelchair (K231750) | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| 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 |
| Polyisoprene Surgical Gloves (K230304) | Puyang Linshi Medical Supplies Co., Ltd. | 2023-08-09 |
| 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 |
| 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 |
| 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 |
| KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K231021) | Kimberly-Clark Corporation | 2023-07-21 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (K230875) | Central Medicare Sdn Bhd | 2023-07-20 |
| AXINON® LDL-p Test System (K210801) | Numares AG | 2023-07-19 |
| MemorialTM Gloves (K231740) | Us Glove Supply | 2023-07-04 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| Manual Wheelchair (A006) (K231110) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2023-06-16 |
| Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) (K230573) | Kossan International Sdn Bhd | 2023-06-13 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K230779) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-06-09 |
| Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349) | Nephron Nitrile, LLC | 2023-06-06 |
| APOLLO ADVANTAGE Nitrile Examination Gloves (K230633) | Dell Corning Corporation | 2023-06-05 |
| Zhenjiang Assure Mechanical Wheelchair,model:K1 (K231320) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 |
| Titanium Turbine (K230888) | Nakanishi, Inc. | 2023-06-02 |
| Disposable Nitrile Gloves (ABC-DG01) (K230542) | Huizhou Anboson Technology Co., Ltd. | 2023-05-31 |
| First Glove Blue Nitrile Examination Gloves Powder Free (K230958) | First Glove Sdn. Bhd. | 2023-05-30 |
| Blue Nitrile Examination Gloves Powder Free (K230601) | Latrile Gloves Private Limited | 2023-05-28 |
| Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (K213289) | Ansell Healthcare Products, LLC | 2023-05-26 |
| BB 8 Sinus Dilation Kit (K230258) | Excelent, Inc. | 2023-05-25 |
| General Cutting Straight (K230106) | Nakanishi, Inc. | 2023-05-24 |
| Green Non Sterile Powder Free Nitrile Examination Gloves (K230564) | Central Medicare Sdn Bhd | 2023-05-23 |
| Endo Motor (K220829) | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 |
| Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437) | Hartalega NGC Sdn. Bhd. | 2023-05-17 |
| Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) (K202993) | Mmj Labs, LLC | 2023-05-15 |
| Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (K230121) | Careglove Global Sdn. Bhd. | 2023-05-15 |
| Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (K230217) | Grand Work Plastic Products Co., Ltd. | 2023-05-13 |
| Disposible Nitrile Gloves (K223280) | Holik Asia Group Co.,Ltd | 2023-05-08 |
| ELEC Master, ELEC Master Dual (K202963) | Mgnewton , Ltd. | 2023-05-05 |
| MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743) | Medschenker, Inc. | 2023-05-03 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color (K221983) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-04-27 |
| Endo Motor (K222548) | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 |
| Curian® Shiga Toxin (K222829) | Meridian Bioscience, Inc. | 2023-04-17 |
| BTL-094 (K221865) | BTL Industries, Inc. | 2023-04-14 |
| Sterile Nitrile Surgical Gloves Powder Free (K222350) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2023-04-13 |
| N2 (K211556) | Megagen Implant Co., Ltd. | 2023-04-05 |
| BioSci™ Disposable Virus Sampling Tubes (K230035) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 |
| G7, Dental Operative Unit and Accessories (K213749) | Shinhung Company, Ltd. | 2023-04-03 |
| Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) | Professional Latex Sdn Bhd | 2023-03-30 |
| CapnoSpot™ Pneumothorax Decompression Indicator (K223625) | Pneumeric, Inc. | 2023-03-28 |
| Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs (K220644) | Yty Industry (Manjung) Sdn Bhd | 2023-03-25 |
| Vinyl examination gloves (K230046) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-03-25 |
| Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (K230002) | Mah Sing Healthcare Sdn. Bhd. | 2023-03-24 |
| BD BACTEC™ Plus Aerobic/F Culture Vials (K222591) | Becton, Dickinson and Company | 2023-03-24 |
| BD BACTEC™ Myco/F Lytic Culture Vials (K222559) | Becton, Dickinson and Company | 2023-03-24 |
| Sterilized Latex Surgical Gloves (K222620) | Suzhou Colour-Way New Material Co., Ltd. | 2023-03-23 |