| WYZ Surgical Mask (K211576) | Wyz Medical Supplies, LLC | 2021-08-19 |
| GX Navigation Instrument System (K202836) | Life Spine, Inc. | 2021-08-19 |
| AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set (K211104) | Conmed Corporation | 2021-08-19 |
| Enteral Extension Sets (K203633) | GBUK Group, Ltd. | 2021-08-19 |
| Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask (K211462) | Xiantao S&J Protective Products Co., Ltd. | 2021-08-19 |
| Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) (K211620) | Shen Wei USA, Inc. | 2021-08-19 |
| Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 (K212296) | Fujifilm Corporation | 2021-08-19 |
| Golden Isles Pedicle Screw System (K212185) | Intelivation, LLC | 2021-08-19 |
| Callaly Tampliner (super plus absorbency) (K212304) | Calla Lily Personal Care, Ltd. | 2021-08-19 |
| CiRx (R) Surgical Mask (K210256) | Ningbo Shun YE Medical Company, Ltd. | 2021-08-19 |
| EIDON FA, EIDON, EIDON AF, EIDON UWFL (K211328) | Centervue S.P.A. | 2021-08-19 |
| EnteraLoc Flow (K210971) | Vonco Products | 2021-08-18 |
| Elecsys HCG STAT (K203227) | Roche Diagnostics | 2021-08-18 |
| Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System (K210318) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-18 |
| Hailie Sensor NF0109 (K211233) | Adherium (Nz), Ltd. | 2021-08-18 |
| Surgical Face Mask (K211631) | Macheng Thimble Technology Investment Co., Ltd. | 2021-08-18 |
| Cellvizio I.V.E. system with Confocal Miniprobes (K212322) | Mauna Kea Technologies | 2021-08-18 |
| Surgical mask (K211454) | Jiangsu Xingtong Biotechnology Group Co., Ltd. | 2021-08-18 |
| Disposable medical surgical mask (K212097) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-08-18 |
| QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K211957) | Globus Medical, Inc. | 2021-08-18 |
| sam X1 Long Duration Ultrasound Device (K211513) | ZetrOZ Systems, LLC | 2021-08-18 |
| Triton (K211813) | Inter-Med / Vista Dental | 2021-08-18 |
| ASPIVIX v1.1 Cervical Suction Tenaculum (K203820) | Aspivix SA | 2021-08-17 |
| STARband (K211376) | Orthomerica Products, Inc. | 2021-08-17 |
| ROSA Hip System (K210998) | Orthosoft D/B/A Zimmer Cas | 2021-08-17 |
| Deep Transcranial Magnetic Stimulation (DTMS) System (K210201) | Brainsway , Ltd. | 2021-08-17 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K203089) | Dexcom, Inc. | 2021-08-17 |
| Disposable Medical Nitrile Gloves (K211708) | Jiangsu Health-Peace Medical Technology Co., Ltd. | 2021-08-17 |
| Journey II Mid-Level Tibial Inserts (K211671) | Smith & Nephew, Inc. | 2021-08-17 |
| Brain Perfusion (BP) application (K201573) | Philips Medical Systems Nederland B.V. | 2021-08-17 |
| Disposable Monopolar Laparoscopic Shafts and Reusable Handles (K210569) | Dannik, LLC | 2021-08-16 |
| Multi-Link X2 ECG Cable and Leadwire System (K211294) | Vyaire Medical, Inc. | 2021-08-16 |
| TruSPECT Radiological Image Processing Station (K212230) | Spectrum Dynamics Medical, Ltd. | 2021-08-16 |
| Adena-Zina System (K212066) | Shanghai Sanyou Medical Co, Ltd. | 2021-08-16 |
| Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove (K203236) | Rhino Health, Inc. | 2021-08-16 |
| Insignia Hip Stem (K211703) | Stryker Orthopaedics | 2021-08-16 |
| Metallic Fabric Electrodes (K202636) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-08-16 |
| NuVent Eustachian Tube Dilation Balloon (K210841) | Medtronic Xomed, Inc. | 2021-08-16 |
| Penumbra System (Reperfusion Catheter RED 72) (K211654) | Penumbra, Inc. | 2021-08-16 |
| CPM Medical Consultants Tibial Revision Knee System (K210695) | Cpm Medical Consultants, LLC | 2021-08-16 |
| iMap 3D Mapping & Navigation System (iMap System) (K201094) | Cardionxt, Inc. | 2021-08-16 |
| I.V. Administration Set (K210381) | Bq Plus Medical Co., Ltd. | 2021-08-14 |
| Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575) | Insulet Corporation | 2021-08-13 |
| Clearblue® Early Digital Pregnancy Test (K200913) | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 |
| Tyber Medical Anatomical Plating System (K203817) | Tyber Medical, LLC | 2021-08-13 |
| MEGA-TMS (K192823) | Soterix Medical, Inc. | 2021-08-13 |
| Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 (K210671) | Weony (Shenzhen) Technology Co., Ltd. | 2021-08-13 |
| ARCO FP-S (K211777) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-08-13 |
| Caretaker Platform, VitalStream Platform, CT5 (K211588) | Caretaker Medical | 2021-08-13 |
| Every Cycle Reusable Tampon Applicator (K211519) | Cycle, LLC | 2021-08-13 |
| EMM Ultrasonic Transducer Cover (K211969) | Exact Medical Manufacturing | 2021-08-13 |
| White Endoseal MTA (K212229) | Maruchi | 2021-08-13 |
| WATCHMAN FXD Curve Access System (K212228) | Boston Scientific Corporation | 2021-08-13 |
| Neodent Implant System - Zirconia Implant System (K210336) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-08-13 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K210958) | Abbott Point of Care, Inc. | 2021-08-13 |
| Jot Dx Insertable Cardiac Monitor (K212206) | Abbott (St. Jude Medical) | 2021-08-13 |
| VITROS Chemistry Products PHBR Slides (K210858) | Ortho-Clinical Diagnostics, Inc. | 2021-08-13 |
| Pitch-Patchs (K211563) | Xiros, Ltd. | 2021-08-13 |
| NFLK-2501 Portable X-ray Unit (K211383) | Neuf, Inc. | 2021-08-13 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K211860) | Anhui Powerguard Technology Co., Ltd. | 2021-08-13 |
| Nisus Touch Negative Pressure Wound Therapy Pump (K203693) | Cork Medical Products, LLC | 2021-08-13 |
| Insignis Subcutaneous Needle Sets (K202279) | Innovative Health Sciences, LLC | 2021-08-13 |
| VERTICALE Navigation Instruments (K212007) | Silony Medical GmbH | 2021-08-12 |
| AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630) | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 |
| Crosser iQ CTO Recanalization System (K203363) | C.R. Bard, Inc. | 2021-08-12 |
| First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup (K210327) | W.H.P.M., Inc. | 2021-08-12 |
| eVolve PACS (K211863) | Evolve Pacs, Inc. | 2021-08-12 |
| Prase-C Anterior Cervical Plate System (K211205) | Gbs Commonwealth Co., Ltd. | 2021-08-12 |
| InferRead CT Stroke.AI (K211179) | Infervision Medical Technology Co., Ltd. | 2021-08-12 |
| Excelsius3D (K210912) | Globus Medical, Inc. | 2021-08-12 |
| SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (K210661) | Quanta Dialysis Technologies, Ltd. | 2021-08-12 |
| Disposable Surgical Gown (K210510) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-12 |
| Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (K210946) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 |
| Disposable Face Mask (K203152) | Chaozhou Cecilia Technology Co., Ltd. | 2021-08-11 |
| Solo, Swing Maxi (K210759) | Medela, LLC | 2021-08-11 |
| Sensatronic Reusable Temperature Probes (K203643) | Sensatronic GmbH | 2021-08-11 |
| QUANTUM® Patient Specific Instrumentation (PSI) System (K211883) | In2bones Sas | 2021-08-11 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K211102) | Abbott Diabetes Care, Inc. | 2021-08-11 |
| uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 |
| Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate (K202536) | Yty Industry (Manjung) Sdn Bhd | 2021-08-11 |
| CONTOUR® NEXT ONE Blood Glucose Monitoring System (K210687) | Ascensia Diabetes Care | 2021-08-11 |
| Z-LINKPC System (K211993) | Zavation Medical Products, LLC | 2021-08-11 |
| Surgical mask (K211552) | Shandong Shengquan New Materials Co., Ltd. | 2021-08-11 |
| Medical Face Mask (K211353) | Shenzhen Lyttop Healthcare Limited | 2021-08-11 |
| Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (K212204) | Cd Diagnostics, Inc. | 2021-08-11 |
| KHEIRON Spinal Fixation System (K211414) | S.M.A.I.O | 2021-08-10 |
| Nitrile Patient Examination Glove (K210730) | American Performance Polymers, LLC | 2021-08-10 |
| PSX Interbody System (K211873) | Alphatec Spine, Inc. | 2021-08-10 |
| Ponto 5 Mini (K211640) | Oticon Medical AB | 2021-08-10 |
| Biodentine XP 500, Biodentine XP 200 (K211799) | Septodont | 2021-08-10 |
| sOLVe Tube (K201026) | Hytek Medical, Inc. | 2021-08-10 |
| EAGLE EDGE AXR90 and AXR120 (K210820) | Alliage S/A Industrias Medico Odontológica | 2021-08-10 |
| X-CUBE 90 (K211300) | Alpinion Medical Systems Co., Ltd. | 2021-08-09 |
| X-CUBE 70 (K211299) | Alpinion Medical Systems Co., Ltd. | 2021-08-09 |
| Edma Synthetic Nitrile Examination Gloves (K211540) | Edma Group, LLC | 2021-08-09 |
| EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor (K211030) | Boston Scientific Corporation | 2021-08-09 |
| Disposable Synthetic Vinyl Nitrile Examination Glove (K211354) | Jiangsu Cureguard Glove Co., Ltd. | 2021-08-08 |
| Diazyme PLAC® Test for Lp-PLA2 Activity (K203136) | Diazyme Laboratories, Inc. | 2021-08-06 |
| Kisses Plus Implant System (K200193) | Achimhai Medical Corporation | 2021-08-06 |
| ClearCorrect System (K210320) | Clearcorrect, LLC | 2021-08-06 |