| Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K183536) | Hartalega NGC Sdn. Bhd. | 2019-08-16 |
| APA Oxy Blade (K191602) | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 |
| Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs (K182089) | Platinum Glove Industries Sdn. Bhd. | 2019-07-30 |
| PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs (K183280) | Smart Glove Corporation Sdn. Bhd. | 2019-07-26 |
| Maxima Electric System (K180845) | Handpiece Headquarters - Hpr, Inc. | 2019-07-25 |
| Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092) | Anhui Intco Medical Products Co., Ltd. | 2019-07-22 |
| Qraypen (K183121) | AIOBIO Co., Ltd. | 2019-07-18 |
| SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994) | Interrad Medical, Inc. | 2019-07-09 |
| Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim (K183149) | Central Medicare Sdn Bhd | 2019-07-04 |
| IKON 40 Manual Wheelchair (K190550) | Broda Seating (Broda Lp) | 2019-07-01 |
| Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove (K183389) | Hartalega NGC Sdn. Bhd. | 2019-06-28 |
| FlexGard Cut-Resistant Glove Liners (K190782) | Ldi Corporation | 2019-06-27 |
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) (K190080) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2019-06-27 |
| Rochal Bioshield Silicone Film (K182733) | Rochal Industries, LLC | 2019-06-27 |
| SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K182851) | O&M Halyard, Inc. | 2019-06-26 |
| Campylobacter Chek (K191442) | Techlab, Inc. | 2019-06-20 |
| Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate (K183354) | Gx Corporation Sdn Bhd | 2019-06-20 |
| Powder-Free Clear Vinyl Patient Examination Gloves (K190095) | Anhui Intco Medical Products Co., Ltd. | 2019-06-20 |
| Campylobacter Quik Chek (K191456) | Techlab, Inc. | 2019-06-20 |
| IDS SHBG (K190121) | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs (K182308) | Sri Trang Gloves (Thailand) Co., Ltd. | 2019-05-30 |
| PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System (K183205) | Emcyte Corporation | 2019-05-30 |
| Manual Wheelchair SIVFH2A102 (K190534) | Jiangsu Horizon Medical Science & Technology Co., Ltd. | 2019-05-29 |
| Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K190606) | Kossan International Sdn Bhd | 2019-05-28 |
| Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K182575) | Jiangxi Jaysun Medcare Co., Ltd. | 2019-05-24 |
| Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (K190077) | Molnlycke Health Care Us, LLC | 2019-05-24 |
| Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K190018) | Ansell Healthcare Products, LLC | 2019-05-23 |
| BACT/ALERT MP Reagent System (K190405) | bioMerieux, Inc. | 2019-05-15 |
| Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) (K182612) | Zibo Yahao Supplies Co., Ltd. | 2019-05-10 |
| Rowheels Revolution 1.0 (K190699) | Rowheels, Inc. | 2019-05-09 |
| Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove (K190159) | Showa Best Glove, Inc. | 2019-05-06 |
| armor LC (K182118) | Mavrik Dental Systems, Ltd. | 2019-05-03 |
| RELIEVA ULTIRRA Sinus Balloon Catheter (K190525) | Acclarent, Inc. | 2019-05-03 |
| Manual Wheelchair W54 (K180309) | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019-05-03 |
| Compex HD (K182017) | Addent, Inc. | 2019-04-29 |
| Element Pediatric Wheelchair (K182840) | Leggero, LLC | 2019-04-29 |
| Relieva Tract Balloon Dilation System (K183090) | Acclarent, Inc. | 2019-04-19 |
| General Cutting Contra Handpiece (K182999) | Nakanishi, Inc. | 2019-04-16 |
| Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) (K182640) | Shandong Hengya Packaging Printing Co.,Ltd | 2019-04-12 |
| PROPHYflex 4 (K181110) | Kaltenbach & Voigt GmbH | 2019-04-10 |
| 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, White 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 (K183287) | Kossan International Sdn Bhd | 2019-04-05 |
| BL-Cart IOL Delivery Cartridge (K182965) | Ast Products, Inc. | 2019-03-29 |
| Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs (K182176) | Pt. Medisafe Technologies | 2019-03-28 |
| VITROS XT Chemistry Products TRIG-CHOL Slides (K190490) | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 |
| Electric Handpiece Motor (K181858) | W&H Dentalwerk Buermoos GmbH | 2019-03-26 |
| InTouch Thermal Camera (K181716) | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019-03-25 |
| Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs (K182554) | He Chuang Plastic & Rubber Co., Ltd. | 2019-03-22 |
| Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (K182948) | Ansell Healthcare Products, LLC | 2019-03-22 |
| Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue (K182383) | Yty Industry (Manjung) Sdn Bhd | 2019-03-19 |
| Vstrip H. pylori Antigen Rapid Test (K183573) | Panion & BF Biotech, Inc. | 2019-03-14 |
| Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs (K182241) | Sri Trang Gloves (Thailand) Co., Ltd. | 2019-03-11 |
| Manual Wheelchair (K180852) | Jiangyin Newrise Medical Equipment Co., Ltd. | 2019-03-01 |
| AeroPro Cordless Prophy System (K180682) | Premier Dental Company Products | 2019-02-27 |
| AnyCheck IMT-100 (K180953) | Dms Co., Ltd. | 2019-02-20 |
| Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (K183375) | Horiba, Ltd. | 2019-02-12 |
| BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166) | bioMerieux, Inc. | 2019-02-11 |
| Ammonia II (K183517) | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K183132) | O&M Halyard, Inc. | 2019-02-05 |
| STRONG Dental Handpieces (K181129) | Saeshin Precision Co., Ltd. | 2019-01-31 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K181106) | Jiangsu Dongxin Medical Technology Co., Ltd. | 2019-01-16 |
| Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs (K181047) | Smart Glove Corporation Sdn. Bhd. | 2019-01-09 |
| OrthoGold 100 (K182682) | Tissue Regeneration Technologies | 2018-12-21 |
| Nitrile Glove Powder Free White (K183068) | Haining Medical Products Co., Ltd. | 2018-12-21 |
| SEM Scanner (Model 200) (DEN170021) | Bruin Biometrics, LLC | 2018-12-20 |
| Sinusway Dilation System (K181838) | 3nt Medical , Ltd. | 2018-12-20 |
| KET-1 Blood Ketone Monitoring System (K182593) | Apex BioTechnology Corp. | 2018-12-18 |
| FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (K181675) | Taidoc Technology Corporation | 2018-12-10 |
| FiXcision (K182664) | Agency For Medical Innovations GmbH | 2018-12-07 |
| Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600) | Better Care Plastic Technology Co., Ltd. | 2018-11-30 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K181857) | Kossan International Sdn Bhd | 2018-11-20 |
| AposTherapy System (K182090) | Apos Medical Assets , Ltd. | 2018-11-16 |
| Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) (K180645) | Hartalega Sdn Bhd | 2018-11-16 |
| SmartBag (SmartPouch) (K181643) | 11 Health Technologies Limited | 2018-11-16 |
| Nitrile Glove Powder Free Black (K182528) | Haining Medical Products Co., Ltd. | 2018-11-15 |
| Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs (K181090) | Invacare Corporation | 2018-11-14 |
| Powder Free Vinyl Patient Examination Gloves (K180381) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018-11-07 |
| Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467) | Diasorin Molecular, LLC | 2018-11-07 |
| PREMIER Platinum HpSA PLUS (K182559) | Meridian Bioscience, Inc. | 2018-11-05 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff (K180786) | Hartalega Sdn Bhd | 2018-11-02 |
| Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (K182096) | Owens & Minor Halyard, Inc. | 2018-11-02 |
| Extended Lipid Panel Assay (K181373) | Laboratory Corporation of America Holdings | 2018-10-18 |
| LS OIL (K173920) | J. Morita USA, Inc. | 2018-10-11 |
| SBG Blue Nitrile Powder Free Medical Examination Glove (K180467) | Showa Best Glove, Inc. | 2018-10-10 |
| SBG Black Nitrile Powder Free Medical Examination Glove (K180468) | Showa Best Glove, Inc. | 2018-10-10 |
| Vinyl Patient Examination Gloves (K182117) | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 2018-10-06 |
| Vinyl Patient Examination Gloves (K182115) | Pingan Medical Products Co., Ltd. | 2018-10-03 |
| Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (K181066) | Eco Medi Glove Sdn. Bhd. | 2018-09-26 |
| PeDIA (K181424) | Pedia, LLC | 2018-09-25 |
| AST Model MA012 and MS019 Rehab Wheelchair (K181795) | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 |
| Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (K182043) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-09-21 |
| Magnesium (K181748) | Abbott Laboratories | 2018-09-12 |
| LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) | DiaSorin, Inc. | 2018-08-31 |
| H. PYLORI QUIK CHEK (K181379) | Techlab, Inc. | 2018-08-21 |
| H. PYLORI CHEK™ (K181400) | Techlab, Inc. | 2018-08-21 |
| Young INFINITY Cordless Handpiece System (K171377) | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 |
| Biodegradable Nitrile Powder Free Examination Glove (Blue) (K173509) | Hartalega Sdn Bhd | 2018-08-17 |
| Forest Dental Unit (K173608) | Forest Dental Products, Inc. | 2018-08-17 |
| Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (K181130) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-08-10 |