| EPIEN Dental Cleanser (K201785) | Epien Medical, Inc. | 2021-09-09 |
| Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes (K211242) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-09 |
| Rocket Platinum Cured Cathter (K210509) | Rocket Medical Plc | 2021-09-09 |
| Curiteva Sacroiliac Joint Fusion System (K210402) | Curiteva, Inc. | 2021-09-09 |
| BlueStar Rx (K203434) | Welldoc, Inc. | 2021-09-08 |
| FEops HEARTguide (DEN200030) | Feops NV | 2021-09-08 |
| Leva Pelvic Health System (K212495) | Renovia, Inc. | 2021-09-08 |
| V8 Diagnostic Ultrasound System (K211945) | Samsung Medison Co., Ltd. | 2021-09-08 |
| Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask (K211832) | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-08 |
| RayStation 11.0 (K211867) | RaySearch Laboratories AB (PUBL) | 2021-09-08 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K211597) | Philips Medical Systems | 2021-09-08 |
| Verifine Mechanical Safety Insulin Syringe (K210712) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-08 |
| Longeviti ClearFit™ OTS Cranial Implants (K212058) | Longeviti Neuro Solutions, LLC | 2021-09-08 |
| Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM (K211127) | Health & Life Co., Ltd. | 2021-09-08 |
| CIRCUL8 Luxe DVT Prevention Device (K211235) | Ortho8, Inc. | 2021-09-08 |
| AmCAD-UT (K203555) | Amcad Biomed Corporation | 2021-09-08 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K211607) | STERIS Corporation | 2021-09-07 |
| Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049) | Applied Medical Resources Corporation | 2021-09-07 |
| OneLIF Intervertebral Body Replacement System (K211769) | Novapproach Spine | 2021-09-07 |
| CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (K211579) | Bolder Surgical, LLC | 2021-09-07 |
| PreferX Delivery System (K210997) | Md3, LLC | 2021-09-07 |
| SANSIN Tubing Sets for Hemodialysis (K202796) | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 |
| Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (K211736) | Shenzhen Osto Technology Company Limited | 2021-09-05 |
| 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 (K212081) | 3M Company | 2021-09-05 |
| Current Health Monitoring System Gen 2 (G2) (K210133) | Current Health | 2021-09-03 |
| Male Latex Condom (K203536) | Global Protection Corp. | 2021-09-03 |
| Infrared Thermometer, Model: HW-1 (K211583) | Dongguan Simzo Electronic Technology Co., Ltd. | 2021-09-03 |
| AROMA GRAND (K211637) | Daeju Meditech Engineering Co., Ltd. | 2021-09-03 |
| C-CURVE Interbody Fusion Device (K210470) | Medicrea International SA | 2021-09-03 |
| Dental Low-speed Handpieces and Accessories (K202786) | Microp Technology (Taiwan), Inc. | 2021-09-03 |
| WoundExpress (K211200) | Huntleigh Healthcare , Ltd. | 2021-09-03 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K210861) | Stryker GmbH | 2021-09-03 |
| KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) | Karl Storz Endoscopy America, Inc. | 2021-09-03 |
| LuxaPrint Ortho Plus (K210940) | Dmg Digital Enterprises SE | 2021-09-03 |
| Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (K201305) | Atrium Medical Corporation | 2021-09-03 |
| ADAS 3D (K212421) | Adas3D Medical S.L. | 2021-09-03 |
| BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (K210342) | STERIS Corporation | 2021-09-03 |
| Dentilube Spray (K202689) | Oxy2plus, LLC | 2021-09-03 |
| Altor Safety 4-Ply Surgical Mask (Model:62232) (K211762) | Altor Safety, LLC | 2021-09-03 |
| Nitrile Examination Gloves Powder Free (Blue) (K210868) | Great Eco Glove Sdn. Bhd. | 2021-09-02 |
| MagnetOs Easypack Putty (K211201) | Kuros Biosciences B.V | 2021-09-02 |
| AI Segmentation (K211881) | Varian Medical Systems, Inc. | 2021-09-02 |
| RayPilot System (K203722) | Micropos Medical AB | 2021-09-02 |
| Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 (K201612) | Viramal Limited | 2021-09-02 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Univers Revers Modular Glenoid System, Standard Augment Baseplates (K211074) | Arthrex, Inc. | 2021-09-02 |
| Nitrile Examination Gloves, Green/ Blue/ Black Color (K211778) | Zhenjiang Suhui Latex Products Co., Ltd. | 2021-09-02 |
| MultiCath, AcQRate Dx Fixed Curve Catheter (K201445) | Biotronik, Inc. | 2021-09-02 |
| Air Relax Pro Model AR-4.0 (K212491) | Diode Art Engineering Doing Business AS Air Relax | 2021-09-02 |
| EASYMAX Tag Self-Monitoring Blood Glucose System (K201258) | Eps Bio Technology Corp. | 2021-09-01 |
| Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) (K210032) | Leadtek Research, Inc. | 2021-09-01 |
| Numen Coil Embolization System; NumenFR Detachment System (K203625) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 |
| Evo sEEG System (K211367) | Neuroone Medical Technologies Corp. | 2021-09-01 |
| Admiral ACP System (K212139) | SeaSpine Orthopedics Corporation | 2021-09-01 |
| EndoLIF Delta-Cage and DoubleWedge-Cage (K203014) | Joimax GmbH | 2021-09-01 |
| Elecsys Vitamin D total III (K210901) | Roche Diagnostics | 2021-09-01 |
| IPL Hair Removal (K211174) | Shenzhen Qiaochengli Technology Co., Ltd. | 2021-09-01 |
| MeMed BV (K210254) | MeMed Diagnostics, Ltd. | 2021-09-01 |
| Tracheal Stent System (K202204) | Micro-Tech (Nanjing) Co., Ltd. | 2021-09-01 |
| Disposable Medical Nitrile Gloves (K211673) | Changzhou Yihua Sanitation Material Co., Ltd. | 2021-09-01 |
| Omeza Collagen Matrix (K211972) | Omeza, LLC | 2021-09-01 |
| Bonine Acupressure Bands (K211823) | Wellspring Pharmaceutical Corporation | 2021-09-01 |
| Leonardo Mini Blue (K210951) | Ceramoptec GmbH | 2021-09-01 |
| Welspun Health Surgical Mask (K211536) | Welspun India Limited | 2021-09-01 |
| SP-1000, SP-2000 (K202395) | Daesung Maref Co., Ltd. | 2021-09-01 |
| Kubtec Mozart (XPERT42) (K210956) | Kub Technologies, Inc. | 2021-08-31 |
| Kubec Xpert 80 Radiography System (K210957) | Kub Technologies, Inc. | 2021-08-31 |
| Ablamap Software (K203084) | Ablacon, Inc. | 2021-08-31 |
| Triton™ Sacroiliac Joint Fixation System (K211449) | Choice Spine, LLC | 2021-08-31 |
| Auto Lung Nodule Detection (K201560) | Samsung Electronics Co., Ltd. | 2021-08-31 |
| DR 800 with DSA, DR 800 (K212145) | Agfa N.V. | 2021-08-31 |
| Adhesive Electrode (K210448) | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021-08-31 |
| Tactoset Injectable Bone Substitute (K212083) | Anika Therapeutics, Inc. | 2021-08-31 |
| PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG (K203636) | Jkh USA, LLC | 2021-08-31 |
| CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (K211704) | Orthofix, Inc. | 2021-08-31 |
| EndoNaut (K212383) | Therenva Sas | 2021-08-31 |
| Ceribell Instant EEG Headband (K210805) | Ceribell, Inc. | 2021-08-30 |
| KMTI S141 Lumbar Interbody Fusion System (K212070) | Kyocera Medical Technologies, Inc. | 2021-08-30 |
| VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (K211630) | bioMerieux, Inc. | 2021-08-30 |
| Paratrooper Plantar Plate Repair System (K211322) | Paragon 28, Inc. | 2021-08-30 |
| Impulse AM Interbody Fusion System (K210090) | Degen Medical | 2021-08-30 |
| StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 (K212103) | Fona S.R.L | 2021-08-30 |
| Senhance Surgical System (K212054) | Asensus Surgical, Inc. | 2021-08-30 |
| Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 (K211041) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2021-08-30 |
| Shoreline Threaded TruProfile® Plate (K211903) | SeaSpine Orthopedics Corporation | 2021-08-30 |
| Nitrile Blue Powder-free Examination Glove (K211390) | Cardinal Health200, LLC | 2021-08-28 |
| AnyOne External Implant System (K203554) | Megagen Implant Co., Ltd. | 2021-08-28 |
| Surgical Mask (K211255) | Tianchang Kanghui Protective Products Co, Ltd. | 2021-08-28 |
| AXS Vecta 46 Intermediate Catheter (K202752) | Stryker Neurovascular | 2021-08-27 |
| Surgical mask (K202746) | Ningbo Jingeao Electronics, Inc. | 2021-08-27 |
| Clear Aligners (K210373) | Shenzhen Yinuo Dental Technology Co.Ltd | 2021-08-27 |
| XSTAT 30 Pouch (K210676) | Revmedx, Inc. | 2021-08-27 |
| Trevo NXT ProVue Retriever (K210502) | Stryker Neurovascular | 2021-08-27 |
| Sonendo Filling Material 5C (K211995) | Sonendo, Inc. | 2021-08-27 |
| LOGIQ E10s, LOGIQ Fortis (K211524) | GE Healthcare | 2021-08-27 |
| ENFit Reusable Enteral Syringe (K203613) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 |
| SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software (K211373) | Siemens Medical Solutions USA, Inc. | 2021-08-27 |
| PrimeTaper EV Dental Implant (K210610) | Dentsply Sirona, Inc. | 2021-08-27 |
| WOLF Thrombectomy System, 6F (K210530) | Devoro Medical, Inc. | 2021-08-27 |
| Virage Navigation System (K212023) | Zimmer Biomet Spine, Inc. | 2021-08-27 |