| Celerity 20 Steam Biological Indicator for IUSS (K202721) | STERIS Corporation | 2021-01-08 |
| Instylla Delivery Kit (K202544) | Instylla, Inc. | 2021-01-07 |
| Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (K202622) | O&M Halyard, Inc. | 2021-01-07 |
| iHealth Clinical Digital Thermometer (K202791) | Andon Health Co, Ltd. | 2021-01-05 |
| Non-contact Infrared Body Thermometer, model:HTD8823US (K200159) | Hetaida Technology Co., Ltd. | 2021-01-05 |
| NeutrArt (K201872) | Asset Medikal Tasarim As. | 2021-01-05 |
| Insulin Syringe (K193273) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-01-05 |
| Promisemed Covered Safety Pen Needle (K202681) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 |
| CrossRoads Tray System (K202268) | Crossroads Extremity Systems, LLC | 2020-12-30 |
| Remunity Pump for Remodulin (treprostinil) Injection (K202690) | Deka Research and Development | 2020-12-30 |
| Self-Contained Biological Indicator (K200970) | True Indicating, LLC | 2020-12-28 |
| Novaerus NV1050 (K200321) | Novaerus Us, Inc. | 2020-12-28 |
| DeRoyal Temperature Monitoring Probe (K200631) | Deroyal Industries, Inc. | 2020-12-23 |
| NovoFine Plus 32G Tip x 4 mm (K202005) | Novo Nordisk, Inc. | 2020-12-19 |
| Fever Garde (K191978) | Hubdic Co., Ltd. | 2020-12-18 |
| BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter (K201075) | Becton, Dickinson and Company | 2020-12-18 |
| Infrared Thermometer (K201980) | Contec Medical Systems Co.,Ltd | 2020-12-18 |
| S dispensing line (K192770) | Aea Srl | 2020-12-17 |
| NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) | International Medical Industries, Inc. | 2020-12-16 |
| Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use (K201284) | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 2020-12-14 |
| Irrisept Wound Debridement and Cleansing System (K202222) | Irrimax Corporation | 2020-12-14 |
| 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K203458) | 3M Company | 2020-12-11 |
| 3M Attest Rapid Readout Biological Indicator (K200996) | 3M Company | 2020-12-11 |
| 3M Comply Hydrogen Peroxide Indicator Tape 1228 (K203285) | 3M Company | 2020-12-10 |
| Cystoject Syringe Lever (K203321) | Urogen Pharma, Ltd. | 2020-12-09 |
| Infrared Body Thermometer (K200781) | Heitaida Technology Co., Ltd. | 2020-12-09 |
| Mini Spike Plus 6/8R (K201469) | B.Braun Medical, Inc. | 2020-12-09 |
| YUWELL Infrared Thermometer (K201864) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-12-07 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284) | 3M Company | 2020-12-07 |
| TempTraq (K201977) | Blue Spark Technologies, Inc. | 2020-12-03 |
| EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (K202270) | K1 Medical, LLC | 2020-12-02 |
| Palm Care Blue Nitrile Examination Gloves Powder Free (K202384) | Hi-Care Thai Gloves Co. , Ltd. | 2020-12-02 |
| WAVICIDE-OPA MEC Indicator (K202565) | Serim Research Corporation | 2020-12-02 |
| Palm Care Latex Examination Powder Free Gloves (K202377) | Hi-Care Thai Gloves Co. , Ltd. | 2020-12-01 |
| Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (K202416) | Kimberly Clark Corporation | 2020-11-30 |
| Promisemed Triple Safety Pen Needle (K202682) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-11-24 |
| ACENT™ Central Venous Catheter (K193158) | Global Medikit Limited | 2020-11-24 |
| NUVO Implant System – NUVO Instrument Kit Cases (K202515) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-11-24 |
| Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) (K193621) | Dongguan E-Test Technology Co., Ltd. | 2020-11-23 |
| Sapphire Infusion Pump, Sapphire administration sets (K192860) | Q Core Medical , Ltd. | 2020-11-19 |
| Liebel-Flarsheim IBP Transfer Set (K193010) | Liebel-Flarsheim Company, LLC | 2020-11-18 |
| EOGas 4 Ethylene Oxide Gas Sterilizer (K192978) | Andersen Sterilizers, Inc. | 2020-11-12 |
| AN1036 Dosimeter (K200334) | Andersen Sterilizers, Inc. | 2020-11-12 |
| EOGas 4 Endo-SteriTest (K192980) | Andersen Sterilizers, Inc. | 2020-11-12 |
| Tyvek Sterilization Pouches with Chevron Seal (K200336) | Andersen Sterilizers, Inc. | 2020-11-12 |
| Sterisheet Sterilization Wrap (K200335) | Andersen Sterilizers, Inc. | 2020-11-12 |
| Sharps container (K201523) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020-11-12 |
| BD PureHub Disinfecting Cap (K193190) | Becton, Dickinson and Company | 2020-11-09 |
| Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) (K203061) | STERIS Corporation | 2020-11-06 |
| Eclipse DermaFlex Cannula (K200017) | Eclipse Medcorp, LLC | 2020-11-05 |
| OtoSet- Ear Cleaning System (K201877) | Safkan, Inc. | 2020-11-05 |
| Sweden & Martina Surgical Tray (Model ZSHORTY-INT) (K182084) | Sweden & Martina S.P.A. | 2020-11-04 |
| Female Luer Lock Cap (K200425) | Medsafety Solutions, LLC | 2020-10-29 |
| OsteoMed ExtremiFix Mini & Small System Tray (K202105) | Osteomed, LLC | 2020-10-29 |
| Curos Jet Disinfecting Cap (K200299) | 3M Company | 2020-10-29 |
| Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) (K202179) | Medline Industries, Inc. | 2020-10-26 |
| Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) (K200150) | Medline Industries, Inc. | 2020-10-26 |
| SURGIPHOR Wound Irrigation System (K202071) | Orthophor, LLC | 2020-10-23 |
| MaxZero Extension Sets with Needle-Free Connector(s) (K193088) | Carefusion, Inc. | 2020-10-23 |
| Infrared ear and forehead thermometer, model YI-100 (K201843) | Wenzhou Yosun Medical Technology Co.,Ltd | 2020-10-23 |
| Vial2Bag Advanced 20mm Admixture Device (K201415) | West Pharmaceutical Services Az, Inc. | 2020-10-21 |
| S.I.N. Instrument Kits (K201688) | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-10-21 |
| Disposable Vinyl Glove (K202010) | Better Health Medical Products Co., Ltd. | 2020-10-16 |
| ARTHROTAP (K201816) | Accuro Technologies, Inc. | 2020-10-16 |
| Droplet Pen Needle 30G & 33G (K202340) | Htl-Strefa S.A | 2020-10-15 |
| Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633) | 0 & M Halyard, Inc. | 2020-10-11 |
| Steripath Micro Blood Collection System (K200661) | Magnolia Medical Technologies, Inc. | 2020-10-08 |
| Infrared Thermometer (K200802) | Shenzhen Urion Technology Co., Ltd. | 2020-10-07 |
| Neonatal Phototherapy System (K200031) | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 |
| Infrared Thermometer Model E127 (K201161) | Bioland Technology, Ltd. | 2020-10-02 |
| Infrared PT2L Digital No-Touch Thermometer (K200710) | Andon Health Co, Ltd. | 2020-10-01 |
| PUGGLE Enteral Feeding Pump and Feeding Set (K200051) | Amsino International, Inc. | 2020-09-25 |
| Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs (K200843) | O&M Halyard, Inc. | 2020-09-22 |
| BD Cathena Safety IV Catheter (K201717) | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-09-22 |
| Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) (K201390) | Medline Industires, Inc. | 2020-09-18 |
| Intellifuse Administration and Intellifuse Blood Administration Sets (K192375) | Smiths Medical Asd, Inc. | 2020-09-18 |
| TK Insulin Syringe with/without Saftey Retractable Device (K191639) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-09-11 |
| Disposable Vinyl Glove (K202008) | Best Care Trading Co., Ltd. | 2020-09-10 |
| BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) | Becton, Dickinson and Company | 2020-09-04 |
| Biodegradable Nitrile Examination Powder Free Glove, Green (K192111) | Top Glove Sdn. Bhd. | 2020-09-03 |
| 3D GraftRasp System (K201900) | Surgentec | 2020-09-03 |
| TK Intravascular Administration Set (K191640) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-26 |
| Deltaven Fast Flash Closed I.V. Catheter Systems (K200373) | Delta Med Spa | 2020-08-26 |
| Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (K193338) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020-08-25 |
| Injection Pen Needle (K192464) | Gangan Medical Technology Jiangsu Co., Ltd. | 2020-08-25 |
| 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 |
| Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug (K200093) | Anhui Lntco Medical Products Co., Ltd. | 2020-08-20 |
| TidalPort-AP Implantable Apheresis Vascular Access Port (K192291) | Norfolk Medical Products, Inc. | 2020-08-20 |
| BD PhaSeal Optima Closed System Drug Transfer Device (K201099) | Becton, Dickinson and Company | 2020-08-12 |
| OMNI PLUS Surgical System (K201953) | Sight Sciences, Inc. | 2020-08-11 |
| 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (K201286) | Nurse Assist, LLC | 2020-08-11 |
| ProSeal™ Closed System drug Transfer Device (CSTD) (K192075) | Epic Medical Pte. , Ltd. | 2020-08-07 |
| MedSource CathMED IV Catheter (K193278) | Medsource Labs | 2020-08-07 |
| Mini Sterilizable Tray (K200858) | Implant Direct Sybron Manufacturing, LLC | 2020-08-06 |
| Steripack cases and Tray Systems (K193066) | Avalign Technologies, Inc. | 2020-08-06 |
| TK Safety Needle (K191644) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-06 |
| 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 |
| MEDRAD Imaging Bulk Package Transfer Spike (K200280) | Bayer Medical Care, Inc. | 2020-07-30 |