| Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs (K201774) | Pt. Medisafe Technologies | 2020-09-16 |
| RGK Daily Range Wheelchairs (K200135) | Rgk Wheelchairs, Ltd. | 2020-09-10 |
| Disposable Vinyl Glove (K202008) | Best Care Trading Co., Ltd. | 2020-09-10 |
| KetoSens BT Blood B-Ketone Monitoring System (K201551) | I-Sens, Inc. | 2020-09-09 |
| SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) (K201829) | Medline Industries, Inc. | 2020-09-09 |
| iCTmotor (WL-1) (K193341) | Dentium Co., Ltd. | 2020-09-04 |
| Biodegradable Nitrile Examination Powder Free Glove, Green (K192111) | Top Glove Sdn. Bhd. | 2020-09-03 |
| Simplant Digital Guide (K193405) | Dentsply Sirona | 2020-09-02 |
| Next Generation Balloon Dilation System (K201115) | Acclarent, Inc. | 2020-08-27 |
| Oral-B iO Test Drive Power Brush Trial Program Kit (K200881) | The Procter & Gamble Company | 2020-08-27 |
| VenSure Balloon Device, VenSure Nav Balloon Device (K201472) | Fiagon GmbH | 2020-08-26 |
| Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201772) | Hartalega NGC Sdn. Bhd. | 2020-08-25 |
| Dental Handpiece (K192809) | Micro-Nx Co., Ltd. | 2020-08-25 |
| Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug (K200093) | Anhui Lntco Medical Products Co., Ltd. | 2020-08-20 |
| Disposable High Speed Air Turbine Handpiece (K193264) | Ningbo Hpdove Dental Instruments Co., Ltd. | 2020-08-11 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) (K201530) | Hartalega NGC Sdn. Bhd. | 2020-08-05 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531) | Hartalega Sdn Bhd | 2020-08-05 |
| Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff (K193666) | Medline Industries, Inc. | 2020-08-04 |
| Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) (K200960) | Medline Industires, Inc. | 2020-07-13 |
| Dental Electrical Motor iRoot Pro (K191276) | Changzhou Bomedent Medical Technology Co.,Ltd | 2020-06-30 |
| Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (K192954) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020-06-19 |
| Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (K200671) | Ansell Healthcare Products, LLC | 2020-06-19 |
| mCare(R) Powder Free Nitrile Orange Examination Gloves (K200967) | Mercator Medical (Thailand), Ltd. | 2020-06-06 |
| VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |
| Latex Examination Powder Free Glove, Aloe Vera (K193150) | Top Glove Sdn. Bhd. | 2020-06-05 |
| bioli lOL Delivery System (K200057) | Ast Products, Inc. | 2020-06-04 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K193555) | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 |
| Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (K200897) | Hartalega Sdn Bhd | 2020-06-01 |
| High-speed air turbine handpiece / Low-speed air turbine handpiece (K181691) | Foshan Wenjian Medical Instrument Co., Ltd. | 2020-05-26 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC (K200453) | Yty Industry (Manjung) Sdn Bhd | 2020-05-01 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581) | Hartalega NGC Sdn. Bhd. | 2020-04-25 |
| Psychemedics Microplate EIA for Cotinine in Hair (K192517) | Psychemedics Corporation | 2020-04-22 |
| Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200181) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020-04-15 |
| KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (K200072) | Kimberly-Clark Corporation | 2020-04-10 |
| Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (K193573) | Molnlycke Health Care Us, LLC | 2020-04-10 |
| Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (K200539) | Sri Trang Gloves (Thailand) Public Company Limited | 2020-04-09 |
| Powder Free Nitrile Examination Glove (Aqua Green) (K200326) | Riverstone Resources Sdn Bhd | 2020-04-09 |
| Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) (K200019) | Hartalega NGC Sdn. Bhd. | 2020-04-06 |
| SensiCare PI and SensiCare PI Micro Surgical Gloves (K193217) | Medline Industries, Inc. | 2020-04-06 |
| Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use (K192988) | Medline Industries, Inc. | 2020-04-01 |
| Manual Wheelchair (K192658) | Jerry Medical Instrument (Shanghai) Co., Ltd. | 2020-04-01 |
| Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential (K191860) | Semperit Technische Produkte Gesellchaft M.B.H. | 2020-03-31 |
| GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K193121) | Eco Medi Glove Sdn. Bhd. | 2020-03-20 |
| Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster (K193581) | Sri Trang Gloves (Thailand) Public Company Limited | 2020-03-20 |
| Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) (K191753) | Medline Industries, Inc. | 2020-03-17 |
| Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192241) | O&M Haylard, Inc. | 2020-03-13 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (K191869) | Molnlycke Health Care Us, LLC | 2020-03-13 |
| JR.MEDIK Latex Surgeon’s Gloves Powder Free (K192328) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020-03-10 |
| SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V (K191915) | Medline Industries, Inc. | 2020-03-06 |
| Lubrina 2 (K190509) | J. Morita USA, Inc. | 2020-03-04 |
| SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) (K192820) | Medline Industries, Inc. | 2020-02-28 |
| Proov Test (K191462) | Mfb Fertility, Inc. | 2020-02-27 |
| EleGARD Patient Positioning System (K191689) | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020-02-13 |
| BreathID Smart System (K193610) | Exalenz Bioscience , Ltd. | 2020-02-06 |
| Infinity / Infinity Cross Flex Dental Systems (K180935) | Olsen Industria E Comercio S.A. | 2020-02-05 |
| Blue Nitrile Examination Gloves Powder Free (K192333) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020-01-24 |
| Medline Glide-On 3G Vinyl Examination Gloves (K192985) | Medline Industries, Inc. | 2020-01-21 |
| Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (K192635) | Wrp Asia Pacific Sdn. Bhd. | 2020-01-17 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| Midwest Rhino XE and Air Motor M (K192409) | Dentsply Sirona | 2020-01-13 |
| Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K192315) | Medline Industries, Inc. | 2020-01-10 |
| Disposable Powder Free Nitrile Examination Glove, Pink/Black Color (K190942) | Ever Growth (Vietnam) Co. , Ltd. | 2020-01-07 |
| SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece (K192412) | Dentalez, Inc. | 2020-01-06 |
| Dillard Nasal Balloon Catheter (K181546) | Intuit Medical Products, LLC | 2020-01-03 |
| mCare® Powder Free Nitrile Black Examination Glove (K192444) | Mercator Medical (Thailand), Ltd. | 2019-12-31 |
| Sterile Latex Surgical Glove, Powder Free (K190241) | Careglove Global Sdn. Bhd. | 2019-12-30 |
| Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs (K190736) | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 |
| Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color (K190860) | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 |
| Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) (K192104) | Medline Industries, Inc. | 2019-12-23 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| SX-One MicroKnife (K192873) | Sonex Health, Inc. | 2019-12-20 |
| Sterile Latex Powder-Free Surgical Gloves (K191898) | Modern Healthcare Corp. | 2019-12-18 |
| Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725) | Riverstone Resources Sdn Bhd | 2019-12-17 |
| EVO 450 series High Speed Handpieces (K190508) | Ttbio Corp. | 2019-12-11 |
| Dental high speed handpiece, Dental low speed handpiece (K181900) | Foshan Cicada Dental Instrument Co, Ltd. | 2019-12-09 |
| mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed (K190876) | Mercator Medical (Thailand), Ltd. | 2019-12-02 |
| TRAUS Dental Handpieces (K182892) | Saeshin Precision Co., Ltd. | 2019-11-26 |
| Blue Latex Examination Powder Free Gloves (K192329) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019-11-25 |
| LZI Cotinine II Enzyme Immunoassay (K192299) | Lin-Zhi International, Inc. | 2019-11-21 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) (K192232) | Hartalega NGC Sdn. Bhd. | 2019-11-08 |
| Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230) | O&M Halyard, Inc. | 2019-11-08 |
| GSP Neonatal Total Galactose kit (K190335) | Perkinelmer, Inc. | 2019-11-06 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K191292) | Anhui Powerguard Technology Co., Ltd. | 2019-11-05 |
| Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein (K190632) | Lenora Glove Pvt , Ltd. | 2019-10-24 |
| Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs (K183562) | Encompass Industries Sdn. Bhd. | 2019-10-23 |
| Mercy babyTAPE (K191174) | Children'S Mercy Hospital | 2019-10-10 |
| Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) | Bausch & Lomb, Inc. | 2019-10-04 |
| Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K183441) | Semperit Investments Asia Pte , Ltd. | 2019-10-04 |
| CEREC Guides (K190059) | Dentsply Sirona | 2019-09-27 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff (K190454) | Hartalega NGC Sdn. Bhd. | 2019-09-26 |
| PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate (K190466) | Shen Wei USA, Inc. | 2019-09-26 |
| Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim (K191800) | Kossan International Sdn Bhd | 2019-09-16 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| Klinly Ultrasonic Tongue Cleaner (K181986) | Kea Products, Ltd. | 2019-09-06 |
| Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (K190403) | Ever Global (Vietnam) Enterprise Corporation | 2019-09-06 |
| K3 (K183347) | Osstem Implant Co., Ltd. | 2019-09-04 |
| Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink (K182382) | Gmp Medicare Sdn Bhd (F25) | 2019-08-29 |
| ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| Osstell Beacon (K181888) | Osstell AB | 2019-08-22 |