| K212860 — 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) | STERIS Corporation Oct 7, 2021 |
| K211077 — Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. Oct 7, 2021 |
| K210024 — NeoMatriX Wound Matrix | Nextgen Biologics, Inc. Oct 7, 2021 |
| K210906 — IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 | Philips Medizin Systeme Boeblingen GmbH Oct 7, 2021 |
| K212279 — Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. Oct 7, 2021 |
| K202063 — TrusFIL Universal Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. Oct 6, 2021 |
| K211719 — ZinRom Nitrile examination gloves | Changzhou Xingrong Medical Technology Co., Ltd. Oct 6, 2021 |
| K212191 — Adhesive Electrodes | Voncare Medical Device Co., Ltd. Oct 6, 2021 |
| K212082 — Picore | Bio-Med USA, Inc. Oct 6, 2021 |
| K212739 — ActiFlip | Parcus Medical, LLC Oct 6, 2021 |
| K211621 — Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | Careplus (M) Sdn Bhd Oct 6, 2021 |
| K212835 — AquaBeam Robotic System | Procept Biorobotics, Corporation Oct 6, 2021 |
| K211508 — Steinmann Pins and Kirschner Wires | Stryker GmbH Oct 5, 2021 |
| K203288 — Cala Trio | Cala Health, Inc. Oct 5, 2021 |
| K211728 — Sterile hypodermic syringes for single use | Jiangsu Kangyou Medical Instrument Co., Ltd. Oct 5, 2021 |
| K211475 — Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 5, 2021 |
| K212233 — RTHawk, HeartVista Cardiac Package | Heartvista, Inc. Oct 5, 2021 |
| K201394 — CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | I-Sens, Inc. Oct 5, 2021 |
| K212036 — Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs | Jiangsu Yanfang Medical Technology Co., Ltd. Oct 5, 2021 |
| K203002 — 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 | Bonebridge AG Oct 5, 2021 |
| K201456 — Scan Monitor | Withings SA Oct 5, 2021 |
| K210406 — Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. Oct 5, 2021 |
| K210490 — ChM 4.5mm Cortical screws | Chm Sp. Z O.O. Oct 5, 2021 |
| K211429 — NAVIPLAN - CT Planning Software for Total Hip Replacement | Naviswiss AG Oct 5, 2021 |
| K211795 — EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. Oct 4, 2021 |
| K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics Oct 4, 2021 |
| K212135 — Dry DBM- A Putty | Seaspine Corporation Oct 4, 2021 |
| K211308 — INNI-CERA | Aon Co., Ltd. Oct 4, 2021 |
| K211425 — Private Stock Labs Surgical Face Mask | J.K. Private Stock, Inc. Oct 4, 2021 |
| K211899 — Surgical Face Mask | Hubei Yi-Ya Protective Products Co., Ltd. Oct 4, 2021 |
| K211405 — Prelude Guide Sheath | Merit Medical Systems, Inc. Oct 4, 2021 |
| K200558 — Smart Neck Stimulator | Guandong Skg Intelligent Technology Co., Ltd. Oct 4, 2021 |
| K211745 — RecoveryAir PRO | Theragun, Inc. Oct 4, 2021 |
| K211368 — IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. Oct 4, 2021 |
| K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical Oct 2, 2021 |
| K202927 — EYE-SYNC | Syncthink, Inc. Oct 2, 2021 |
| K211332 — D Camera Controller | Richard Wolf Medical Instruments Corporation Oct 1, 2021 |
| K210140 — electrocardiograph: SE-1202 | Edan Instruments, Inc. Oct 1, 2021 |
| K210002 — STELLA BIO | Egzotech Sp. Z O. O. Oct 1, 2021 |
| K210139 — Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. Oct 1, 2021 |
| K212201 — PENTAX Medical Auto Leakage Tester SHA-P6 | Pentax Of America, Inc. Oct 1, 2021 |
| K212414 — OSSDSIGN Cranial PSI | Ossdsign AB Oct 1, 2021 |
| K210270 — Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. Oct 1, 2021 |
| K201934 — Surgimatix Absorbable Fixation System | Surgimatix, Inc. Oct 1, 2021 |
| K212114 — Elekta Unity | Elekta Solutions AB Oct 1, 2021 |
| DEN190055 — iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. Oct 1, 2021 |
| K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. Oct 1, 2021 |
| K212813 — Zenition 70 | Philips Medical Systems Nederland B.V. Oct 1, 2021 |
| K212433 — Anthem Fracture System | Globus Medical, Inc. Oct 1, 2021 |
| K211221 — Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. Oct 1, 2021 |