| SwiftMR (K210999) | Airs Medical, Inc. | 2021-10-14 |
| ALGO 7i (K211147) | Path Medical GmbH | 2021-10-14 |
| AFS Medical Sterile Single-Use Access Port System (K202688) | Afs Medical Co. , Ltd. | 2021-10-14 |
| Family of Venus RF Systems - Venus Freedom (K211461) | Venus Concept USA, Inc. | 2021-10-14 |
| Vittra APS Unique (K210231) | Dentscare Ltda | 2021-10-14 |
| SCORPION Portal Vein Access Set (K213002) | Argon Medical Devices | 2021-10-14 |
| Brainance MD (K202808) | Advantis Medical Imaging Single Member P.C. | 2021-10-14 |
| Medical Protective Masks (K212205) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-10-14 |
| Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit (K211121) | Intera Oncology, Inc. | 2021-10-14 |
| StrokeSENS LVO (K212261) | Circle Neurovascular Imaging, Inc. | 2021-10-14 |
| Sapphire NC 24 (K211807) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 |
| Nitrile Patient Examination Gloves (K211914) | Yingxiang Glove Products Co., Ltd. | 2021-10-14 |
| Sterile Syringe With Safety Needle (K211753) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-10-14 |
| Medical Nitrile Examination Gloves (K212014) | Jiangxi Ronglai Medical Technology Co., Ltd. | 2021-10-13 |
| UltraCal XS (K211905) | Ultradent Products, Inc. | 2021-10-13 |
| EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device (K212908) | Neuravi, Ltd. | 2021-10-13 |
| MiniLoad Syringe (K212544) | Ocuject, LLC | 2021-10-13 |
| Video Endoscopy System, 3D Video Endoscopy System (K210116) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 |
| SPRINT PNS System (K211801) | Spr Therapeutics, Inc. | 2021-10-13 |
| Proclean - Nitrile Powder Free Examination Gloves (K211374) | Dr.Boo Company Limited | 2021-10-13 |
| CoreLink Navigation Instruments (K212825) | Corelink, LLC | 2021-10-13 |
| Disposable Surgical Mask (Model: YYKZ-01) (K210845) | Jiaxing Amazing Travel-Ware Co., Ltd. | 2021-10-12 |
| BC Reflex Uni Knee System (K212307) | Bodycad Laboratories, Inc. | 2021-10-12 |
| Signature™ ONE System (K212560) | Orthosoft Inc (D/B/A Zimmer Cas) | 2021-10-12 |
| Correx Software (K212552) | Vilex, LLC | 2021-10-12 |
| Idys-C ZP 3DTi (K212562) | Clariance, SA | 2021-10-12 |
| Nitrile examination gloves (K211927) | Fitone Latex Products Co., Ltd. Guangdong | 2021-10-12 |
| VBrain-OAR (K212116) | Vysioneer, Inc. | 2021-10-12 |
| Child Face Mask (K201514) | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 |
| Straumann CARES P-Series CAD/CAM System (K203750) | Institut Straumann AG | 2021-10-09 |
| STERRAD 100NX Sterilizer with ALLClear Technology (K212174) | Advanced Sterilization Products, Inc. | 2021-10-09 |
| Clear Aligner (K203688) | Wuxi EA Medical Instruments Technologies Limited. | 2021-10-08 |
| B4C System (K201989) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 |
| INTEGRA Wound Matrix (Macro-Channels) (K210128) | Integra LifeSciences Corporation | 2021-10-08 |
| ABCcolla Bone Matrix (K212156) | Acro Biomedical Co., Ltd. | 2021-10-08 |
| Infrared Thermometer (Model K9) (K203497) | Kangzhan Communication Electronics Co., Ltd. | 2021-10-08 |
| Esophageal TTS Stent (K211706) | Taewoong Medical Co., Ltd. | 2021-10-08 |
| Single-Use Medical Face Mask (K210622) | Jiangxi Hongda Medical Equipment Group Co., Ltd. | 2021-10-08 |
| ProLift Micro Expandable Spacer System (K212520) | Life Spine, Inc. | 2021-10-08 |
| Medical Surgical Mask (K210813) | Sichuan Pharmaceutical., Inc. | 2021-10-08 |
| The Micro Screw System, Micro Screw System Basic (K201210) | Hager& Meisinger GmbH | 2021-10-08 |
| Medical Examination Gloves (K212078) | Guangdong Gymda Medical Technology Co.,Ltd | 2021-10-08 |
| Streamline Surgical System (K211680) | New World Medical, Inc. | 2021-10-08 |
| Cohitech Reusable Tampon Applicator (K212479) | Cotton High Tech S.L. | 2021-10-08 |
| PuraStat-OM (K210211) | 3-D Matrix, Inc. | 2021-10-08 |
| Carescape SpO2 - Masimo (K212876) | Masimo Corporation | 2021-10-08 |
| OASIS MRI System (K211406) | Hitachi Healthcare Americas | 2021-10-07 |
| Superior Hair Remover (K210376) | Guangzhou Haoxingwan Technology Co., Ltd. | 2021-10-07 |
| SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (K212860) | STERIS Corporation | 2021-10-07 |
| IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 (K210906) | Philips Medizin Systeme Boeblingen GmbH | 2021-10-07 |
| NeoMatriX Wound Matrix (K210024) | Nextgen Biologics, Inc. | 2021-10-07 |
| Surgical Gown (K211077) | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2021-10-07 |
| Digital Intraoral X-ray Imaging System (K212279) | Iray Technology Taicang , Ltd. | 2021-10-07 |
| Sterile syringes for single use with/without needle (K211211) | Azur Medical Company, Inc. | 2021-10-07 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (K212065) | Remington Medical, Inc. | 2021-10-07 |
| Adhesive Electrodes (K212191) | Voncare Medical Device Co., Ltd. | 2021-10-06 |
| Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) (K211621) | Careplus (M) Sdn Bhd | 2021-10-06 |
| ZinRom Nitrile examination gloves (K211719) | Changzhou Xingrong Medical Technology Co., Ltd. | 2021-10-06 |
| ActiFlip (K212739) | Parcus Medical, LLC | 2021-10-06 |
| Picore (K212082) | Bio-Med USA, Inc. | 2021-10-06 |
| TrusFIL Universal Composite Restorative (K202063) | Rizhao Huge Biomaterials Company, Ltd. | 2021-10-06 |
| AquaBeam Robotic System (K212835) | Procept Biorobotics, Corporation | 2021-10-06 |
| Vital Signs Monitors (K211475) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 |
| SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System (K203002) | Bonebridge AG | 2021-10-05 |
| Scan Monitor (K201456) | Withings SA | 2021-10-05 |
| RTHawk, HeartVista Cardiac Package (K212233) | Heartvista, Inc. | 2021-10-05 |
| Steinmann Pins and Kirschner Wires (K211508) | Stryker GmbH | 2021-10-05 |
| CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System (K201394) | I-Sens, Inc. | 2021-10-05 |
| Bipolar Coagulation Foreceps (K210406) | Hangzhou AGS MedTech Co., Ltd. | 2021-10-05 |
| NAVIPLAN - CT Planning Software for Total Hip Replacement (K211429) | Naviswiss AG | 2021-10-05 |
| Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs (K212036) | Jiangsu Yanfang Medical Technology Co., Ltd. | 2021-10-05 |
| Sterile hypodermic syringes for single use (K211728) | Jiangsu Kangyou Medical Instrument Co., Ltd. | 2021-10-05 |
| ChM 4.5mm Cortical screws (K210490) | Chm Sp. Z O.O. | 2021-10-05 |
| Cala Trio (K203288) | Cala Health, Inc. | 2021-10-05 |
| Prelude Guide Sheath (K211405) | Merit Medical Systems, Inc. | 2021-10-04 |
| RecoveryAir PRO (K211745) | Theragun, Inc. | 2021-10-04 |
| VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (K201312) | Ortho Clinical Diagnostics | 2021-10-04 |
| Private Stock Labs Surgical Face Mask (K211425) | J.K. Private Stock, Inc. | 2021-10-04 |
| Dry DBM- A Putty (K212135) | Seaspine Corporation | 2021-10-04 |
| INNI-CERA (K211308) | Aon Co., Ltd. | 2021-10-04 |
| Surgical Face Mask (K211899) | Hubei Yi-Ya Protective Products Co., Ltd. | 2021-10-04 |
| EzDent-i/ E2/ Prora View/ Smart M Viewer (K211795) | Ewoosoft Co., Ltd. | 2021-10-04 |
| IPL Hair Remover, Model: G993, G996, G998 and G885 (K211368) | Shenzhen Mywin Technology Co., Ltd. | 2021-10-04 |
| Smart Neck Stimulator (K200558) | Guandong Skg Intelligent Technology Co., Ltd. | 2021-10-04 |
| Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931) | Dixi Medical | 2021-10-02 |
| EYE-SYNC (K202927) | Syncthink, Inc. | 2021-10-02 |
| HRSpheres Narrow-Size Embolic Microspheres (K210562) | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 |
| Surgimatix Absorbable Fixation System (K201934) | Surgimatix, Inc. | 2021-10-01 |
| Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (K210139) | Edan Instruments, Inc. | 2021-10-01 |
| Porous Patella and Porous Tibia Baseplate (K211221) | Smith & Nephew, Inc. | 2021-10-01 |
| Anthem Fracture System (K212433) | Globus Medical, Inc. | 2021-10-01 |
| Medical Endoscope Image Processing System (K210270) | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2021-10-01 |
| STELLA BIO (K210002) | Egzotech Sp. Z O. O. | 2021-10-01 |
| OSSDSIGN Cranial PSI (K212414) | Ossdsign AB | 2021-10-01 |
| Elekta Unity (K212114) | Elekta Solutions AB | 2021-10-01 |
| PENTAX Medical Auto Leakage Tester SHA-P6 (K212201) | Pentax of America, Inc. | 2021-10-01 |
| BRIUS Planner Software (K212828) | Brius Technologies, Inc. | 2021-10-01 |
| D Camera Controller (K211332) | Richard Wolf Medical Instruments Corporation | 2021-10-01 |
| Zenition 70 (K212813) | Philips Medical Systems Nederland B.V. | 2021-10-01 |
| E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (K200011) | Microport Orthopedics, Inc. | 2021-10-01 |