| Neocis Guidance System (NGS) with Intraoral Fiducial Array (K211129) | Neocis, Inc. | 2021-07-28 |
| Purism Disposable Surgical Mask (K210856) | Chuzhou Daddy'S Choice Science and Technology Co., Ltd. | 2021-07-28 |
| NIO-I (K211395) | Einstein Works, LLC | 2021-07-28 |
| Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (K201657) | Corin, Ltd. | 2021-07-28 |
| Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211875) | William Cook Europe Aps | 2021-07-28 |
| Broncho Videoscope System (K210379) | Scivita Medical Technology Co., Ltd. | 2021-07-28 |
| Diode Laser Machine, Model Number: BM-100 (K211335) | Zhengzhou Bestview ST Co., Ltd. | 2021-07-28 |
| MIS Ti-base abutment (K211225) | Dentsply Sirona | 2021-07-28 |
| TAIJI Professional Series Level 3 Surgical Face Mask (K211861) | Taiji Medical Supplies, Inc. | 2021-07-28 |
| Pac-Dent Denture Base Resin (K210189) | Pac-Dent, Inc. | 2021-07-28 |
| Electrode Market Disposable Surface Electrodes (K211839) | Electrode Market Co., Ltd. | 2021-07-28 |
| Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors (K211455) | Shen Wei USA, Inc. | 2021-07-28 |
| ELEOS Limb Salvage System (K211677) | Onkos Surgical | 2021-07-28 |
| Braun Silk.expert Mini (K211994) | Cyden Limited | 2021-07-28 |
| Dental Impression Material (K211489) | Nanchang Dental Bright Technology Co., Ltd. | 2021-07-28 |
| Surgical Mask (K211497) | Honeywell Safety Products | 2021-07-28 |
| Disposable Ear Thermometer Probe Cover (K203431) | Huaian Zhongxin Packing Material Co., Ltd. | 2021-07-28 |
| FINE Osteotomy (K211646) | Bodycad Laboratories, Inc. | 2021-07-28 |
| Rist 071 Radial Access Guide Catheter (K211990) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 |
| Us2.v1 (K210791) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2021-07-27 |
| Senhance Surgical System (K211325) | Asensus Surgical, Inc. | 2021-07-27 |
| Volpara Imaging Software (K211279) | Volpara Health Technologies Limited | 2021-07-27 |
| Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (K210016) | Integra LifeSciences Corporation | 2021-07-27 |
| Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair (K201326) | Psychemedics Corporation | 2021-07-27 |
| 1Derful HS, 1Derful HT (K210884) | 1derful, Inc. | 2021-07-27 |
| Aveir Introducer (K211989) | ABBOTT MEDICAL | 2021-07-27 |
| Fixxsure Anterior Lumbar Plate and Screw System (K211932) | Oak Tree Engineering, LLC | 2021-07-27 |
| DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) | Ra Medical Systems,Inc | 2021-07-27 |
| doctorgram Stethoscope DES-I (K210736) | Gv Concepts | 2021-07-27 |
| PET VCAR (K211247) | GE Medical Systems SCS | 2021-07-27 |
| Insight Agile DRF (K210469) | Imaging Engineering, LLC | 2021-07-27 |
| Route 92 Medical Full Length 088 Access System (K210635) | Route 92 Medical, Inc. | 2021-07-27 |
| ClariCT.AI (K212074) | Claripi, Inc. | 2021-07-27 |
| aPROMISE (K211655) | Exini Diagnostics AB | 2021-07-27 |
| AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (K210477) | AtriCure, Inc. | 2021-07-26 |
| Vision Monitor - MonpackONE (K211643) | Metrovision | 2021-07-26 |
| Pac-Dent Ceramic Nanohybrid Resin (K210412) | Pac-Dent, Inc. | 2021-07-26 |
| OncoMate MSI Dx Analysis System (K200129) | Promega Corporation | 2021-07-26 |
| MASC Surgical Mask (K211984) | Mid-America Safety Corp. | 2021-07-25 |
| Disposable Vinyl Nitrile Synthetic Gloves Powder Free (K211262) | Tangshan Hongyun Healthcare Products Co., Ltd. | 2021-07-24 |
| Medical Face Mask (K211363) | Hubei Kangning Protective Products Co., Ltd. | 2021-07-24 |
| IS Multi Unit Abutment System (K210903) | Neobiotech Co., Ltd. | 2021-07-23 |
| Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612) | Thermo Fisher Scientific | 2021-07-23 |
| Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. (K210311) | Shenzhen Mismon Technology Co., Ltd. | 2021-07-23 |
| SC1 Handheld Ultrasound Imaging System (Model: SC1) (K210468) | Fcu Co., Ltd. | 2021-07-23 |
| HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (K201160) | M.I.Tech Co., Ltd. | 2021-07-23 |
| VS Newborn Heart Rate Monitor (K201887) | Surepulse Medical Limited | 2021-07-23 |
| Peregrine Endoscopy System (K202727) | 3nt Medical , Ltd. | 2021-07-23 |
| da Vinci SP Surgical System (SP1098) (K211316) | Intuitive Surgical, Inc. | 2021-07-23 |
| Flex-Thread™ Distal Fibula lntramedullary Nail System (K212030) | Flower Orthopedics Corporation Dba Conventus Flower | 2021-07-23 |
| MySpine WebPlanner & MyBalance (K211386) | Medacta International S.A. | 2021-07-23 |
| Disposable Microwave Therapeutic Antennas (K201265) | Nanjing Eco Microwave System Co., Ltd. | 2021-07-23 |
| CardioCurve Steerable Sheath (K210185) | Talon Surgical | 2021-07-23 |
| Altor Safety 3-Ply Surgical Mask (Model:62222) (K211249) | Altor Safety, LLC | 2021-07-23 |
| GI Genius (K211951) | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-07-23 |
| Klassic Knee System (K211602) | Total Joint Orthopedics, Inc. | 2021-07-23 |
| IntraLock System (K210159) | Fusion Orthopedics, LLC | 2021-07-23 |
| Disposable IV catheter (K202060) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2021-07-23 |
| Nitrile Patient Examination Gloves (K211012) | Huayuan Medical Technology(Shangqiu) Co., Ltd. | 2021-07-23 |
| HMB32 Dialysis Solution (K212052) | Haemopharm Biofluids S.R.L. | 2021-07-23 |
| Blustone Synergy Diamond SA Cervical System (K210382) | Blustone Synergy, LLC | 2021-07-23 |
| Infrared Forehead Thermometer, Model BSX976 (K202296) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2021-07-23 |
| Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (K210143) | Foshan Nanhai Plus Medical Co, Ltd. | 2021-07-22 |
| DemarkQ WOW, DemarkQ POP (K203214) | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-22 |
| NIO+ Adult (K211968) | Waismed, Ltd. | 2021-07-22 |
| Arthrex SynergyID Endoscopic Imaging System (K202582) | Arthrex, Inc. | 2021-07-22 |
| FlowSaver Blood Filter (K210176) | Inari Medical | 2021-07-22 |
| POLARSTEM Cemented Femoral Stem (K203175) | Smith & Nephew, Inc. | 2021-07-22 |
| Reveal LINQ Insertable Cardiac Monitor (K212008) | Medtronic, Inc. | 2021-07-22 |
| Temp Pal (K202603) | Iweecare Co., Ltd. | 2021-07-22 |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633) | Canon Medical Systems Corporation | 2021-07-22 |
| Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (K211220) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-07-22 |
| ExacTrac Dynamic (K211939) | Brainlab AG | 2021-07-22 |
| DELTA XTEND Reverse Shoulder System (K203694) | Depuy Ireland UC | 2021-07-22 |
| DC-Air and Athlos-1 and Athlos-Air (K211688) | Athlos OY | 2021-07-22 |
| Single-use medical face mask (K210391) | Zhuhai Herald Datanetics Limited. | 2021-07-22 |
| QSM software, QSMetric (K210415) | Medimagemetric, LLC | 2021-07-22 |
| syngo.CT Skull Unfolding (K203411) | Siemens Medical Solutions USA, Inc. | 2021-07-22 |
| WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (K210579) | OTU Medical, Inc. | 2021-07-22 |
| Medline UNITE® Digital Fusion Screw System (K211944) | Medline Industries, Inc. | 2021-07-22 |
| Promisemed Insulin Pen Needle (K210059) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-07-21 |
| CHIRAVAC Blood Collection Needles (K201009) | Chirana T. Injecta | 2021-07-21 |
| CD Horizon Spinal System (K211958) | Medtronic Sofamor Danek USA, Inc. | 2021-07-21 |
| MolecuLightDX (K211901) | MolecuLight, Inc. | 2021-07-21 |
| Single-Use Surgical Mask Model FE2311B (K210970) | Byd Precison Manufacturer Co., Ltd. | 2021-07-21 |
| Nitrile Patient Examination Glove (K210686) | Yunnan Huazhiyuan Medical Technology Co., Ltd. | 2021-07-21 |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K211223) | Boston Scientific Corporation | 2021-07-21 |
| AbutmentCAD (K193352) | Exocad GmbH | 2021-07-21 |
| AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown (K210688) | O&M Halyard, Inc. | 2021-07-21 |
| Aduro light therapy Handheld (K203271) | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-21 |
| Surgical face mask (Model: Flat Ear Loop/CN102) (K203534) | Crown Name Disposable Hygiene Products Fty., Ltd. | 2021-07-21 |
| LifeSignals Multi-Parameter Remote Monitoring Platform (K202868) | Lifesignals, Inc. | 2021-07-21 |
| Grivamax Family of Lasers, Models 272 and 148 (K211192) | Leana Orders, Inc. | 2021-07-20 |
| Disposable Nitrile Medical Examination Glove (K210684) | Jiangsu Cureguard Glove Co., Ltd. | 2021-07-20 |
| Change Healthcare Anatomical AI (K210719) | Change Healthcare Canada Company | 2021-07-20 |
| Chest-CAD (K210666) | Imagen Technologies, Inc. | 2021-07-20 |
| The Slide (K203712) | Biotex, Inc. | 2021-07-20 |
| Elecsys Syphilis (K211302) | Roche Diagnostics | 2021-07-20 |
| TKO Composite Bite Turbo Gel (K210349) | Reliance Orthodontic Products, Inc. | 2021-07-20 |
| RF Thermal System (K210129) | Luvo Medical Technologies, Inc. | 2021-07-20 |