| B-Capta (K202154) | Livanova Deutschland, GmbH | 2021-04-01 |
| KOSMO Femoral Stem (K202768) | B-One Ortho, Corp. | 2021-04-01 |
| Idys LLIF 3DTi (K202032) | Clariance, Sas | 2021-04-01 |
| Omron Model BP7900 Blood Pressure Monitor + EKG (K202228) | Omron Healthcare, Inc. | 2021-04-01 |
| AMG PMP Pediatric (K202206) | Eurosets S.R.L | 2021-04-01 |
| Nanox Cart X-ray System (K203782) | Nano-X Imaging , Ltd. | 2021-04-01 |
| Pentax Medical Video Duodenoscope ED32-i10 (K202365) | Pentax of America, Inc. | 2021-04-01 |
| TSolution One Total Knee Application (K210668) | THINK Surgical, Inc. | 2021-04-01 |
| Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo (K202129) | Largan Medical Co., Ltd. | 2021-04-01 |
| Gili Pro BioSensor (also known as “Gili BioSensor System”) (DEN200038) | Continuse Biometrics , Ltd. | 2021-04-01 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K210340) | Canon Medical Systems Corporation | 2021-04-01 |
| Simpleware ScanIP Medical (K203195) | Synopsys (Northern Europe) , Ltd. | 2021-04-01 |
| Digital Thermometer Model T103, T104 (K201879) | Bioland Technology, Ltd. | 2021-03-31 |
| Myriad Particles (K200502) | Aroa Biosurgery , Ltd. | 2021-03-31 |
| Surgical Mask-Models CR02-2, CR02 (K202424) | Foshan Xinbao Technology Co., Ltd. | 2021-03-31 |
| syngo.CT Lung CAD (K203258) | Siemens Healthcare GmbH | 2021-03-31 |
| Longeviti PMMA Static Cranial Implant (K210616) | Longeviti Neuro Solutions, LLC | 2021-03-31 |
| EnCor Breast Biopsy Probe with Rinse Tube (K210654) | Senorx, Inc. | 2021-03-31 |
| SIS System (Version 5.1.0) (K210071) | Surgical Information Sciences, Inc. | 2021-03-31 |
| Blue Nitrile Exam Glove, Powder Free (K210057) | Real Star Medical Technology Co., Ltd. | 2021-03-31 |
| Secure Wear USA Surgical Face Mask (K203101) | Secured Ortho Manufacturing of America, LLC | 2021-03-31 |
| MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea (K203443) | Siemens Medical Solutions USA, Inc. | 2021-03-31 |
| Pulsehaler (K203378) | Respinova, Ltd. | 2021-03-31 |
| Avitus(r) Bone Harvester (K210631) | Avitus Orthopaedics, Inc. | 2021-03-31 |
| Guidion (K210110) | Imds Operations B.V. | 2021-03-31 |
| Blue Nitrile Exam Glove, Powder Free (K210058) | Great Harvest Trading Co., Ltd. | 2021-03-30 |
| PicoSure Workstation (K210226) | Cynosure, LLC | 2021-03-30 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| ivi N3003 Surgical face Mask, ivi N6006 Surgical mask (K201896) | Iob Medical, Inc. | 2021-03-30 |
| Surgical Face Masks (K202708) | Intco Medical(Hk) Co., Ltd. | 2021-03-30 |
| 3M Bair Hugger Temperature Management System (Model 675) (K210603) | 3M Company | 2021-03-30 |
| EMPOWR Porous Femur with HAnano SurfaceTM (K210308) | Encore Medical L.P. | 2021-03-30 |
| E-Denture Pro (K203641) | Envisiontec GmbH | 2021-03-30 |
| BOMEDENT Apex locator, WISMY Apex locator (K203836) | Changzhou Bomedent Medical Technology Co.,Ltd | 2021-03-30 |
| DORO QR3 Headrest System (Aluminum) (K203505) | Pro Med Instruments GmbH | 2021-03-29 |
| REMI (K203827) | Epitel, Inc. | 2021-03-29 |
| StarGuide (K210173) | GE Healthcare | 2021-03-29 |
| LumiCare Caries Diagnostic Rinse (K200601) | GreenMark Biomedical, Inc. | 2021-03-29 |
| LaserCap Family of Lasers 300, 224, 120 & 80 (K203826) | Transdermal Cap, Inc. | 2021-03-29 |
| EMMA Capnograph (K201590) | Masimo Corporation | 2021-03-29 |
| Surgical Mask (K202191) | Wuhan Zonsen Medical Products Co., Ltd. | 2021-03-29 |
| DVT-4000S (K203417) | Daesung Maref Co., Ltd. | 2021-03-28 |
| Toro-L Interbody Fusion System (K203038) | Integrity Implants, Inc. | 2021-03-26 |
| DermaV Laser System (K203788) | Lutronic Corporation | 2021-03-26 |
| Oxehealth Vital Signs (DEN200019) | Oxehealth Limited | 2021-03-26 |
| Lucent 3D Spinal System (K203254) | Spinal Elements, Inc. | 2021-03-26 |
| GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (K210534) | Gramercy Extremity Orthopedics, LLC | 2021-03-26 |
| Surgivisio system (K202547) | Surgivisio | 2021-03-26 |
| Tranberg CLS Laser Applicator (K201466) | Clinical Laserthermia Systems, AB | 2021-03-26 |
| TruAbutment DS, TruBase S (K201197) | Truabutment, Inc. | 2021-03-26 |
| TandemHeart Pump and Escort Controller (K202751) | Cardiacassist, Inc. | 2021-03-26 |
| Disposable Face Mask (K202905) | Jiangsu Excellence Medical Supplies Co., Ltd. | 2021-03-26 |
| ETD4000 (K202725) | Therasigma, LLC | 2021-03-26 |
| i-ED COIL System (K210638) | Kaneka Medical America, LLC | 2021-03-26 |
| RG 3ml Medication Cartridge (K201634) | Chengdu Shifeng Medical Technology Co., Ltd. | 2021-03-26 |
| Spacelabs Lifescreen PRO Analyzer (K201921) | Spacelabs Healthcare, Ltd. | 2021-03-26 |
| AllerBlock Junior (K201734) | Nasaleze International, Ltd. | 2021-03-26 |
| FairFix Adjustable Button System (K203259) | Medacta International S.A. | 2021-03-26 |
| Disposable Surgical Face Mask (K203685) | Xiantao Zhongyi Safety & Protection Products Co., Ltd. | 2021-03-26 |
| DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System (K210205) | Synthes (USA) Products, LLC | 2021-03-26 |
| Portable Neuromodulation Stimulator (PoNS) (DEN200050) | Helius Medical, Inc. | 2021-03-26 |
| MyCRO Band (K201426) | Otto Bock Healthcare LP | 2021-03-26 |
| Humeral Eccentric Reverse Metaphysis (K210207) | Medacta International S.A. | 2021-03-26 |
| A8, A9 Anesthesia System (K201957) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 |
| FIREBIRD SI Fusion System (K210667) | Orthofix, Inc. | 2021-03-25 |
| Air compression therapy system FO-3001; Air compression therapy system FO-3008 (K201982) | Foshan Hongfeng Co., Ltd. | 2021-03-25 |
| Arthrex Patella SuturePlates (K203834) | Arthrex, Inc. | 2021-03-25 |
| Surgical Masks, Model SNN200640 & MN112 (K203776) | Sq Medical Supplies, Inc. | 2021-03-25 |
| Low-frequency Multi-function physiotherapy instrument (K200177) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2021-03-25 |
| LEGION Porous CR Narrow Femoral Components (K210566) | Smith & Nephew, Inc. | 2021-03-25 |
| Disposable Medical Mask (K202133) | Hangzhou Qianzhiya Sanitary Products Co., Ltd. | 2021-03-25 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K202083) | Shen Wei USA, Inc. | 2021-03-25 |
| ANAM Test System (K201376) | Vista Lifesciences, Inc. | 2021-03-25 |
| DiaPaste (K210333) | DiaDent Group International | 2021-03-25 |
| NeedleSmart Professional (NS Pro) (K202073) | Needlesmart Limited | 2021-03-25 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (K203273) | Echosens | 2021-03-25 |
| ST-Z5 (K201878) | Z-Systems AG | 2021-03-25 |
| NEBULAE SRS Laparoscopic Surgical Smoke Removal System (K202944) | Northgate Technologies, Inc. | 2021-03-25 |
| Nalu Neurostimulation System (K203547) | Boston Scientific Neuromodulation | 2021-03-25 |
| BRS Procedure Face Mask (K202824) | Blackbriar Regulatory Services, LLC | 2021-03-25 |
| STERIZONE VP4 Test Pack (K203560) | Tso3 Inc., Now A Part of Stryker | 2021-03-24 |
| Medical disposable face mask non sterile (K202650) | Guangdong Zhong Ling Industrial Group Co., Ltd. | 2021-03-24 |
| ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (K203133) | Envizion Medical , Ltd. | 2021-03-24 |
| White ENDOSEAL MTA (K202015) | Maruchi | 2021-03-24 |
| Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (K203225) | Canon Medical Systems Corporation | 2021-03-24 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K202453) | Safecare Biotech (Hangzhou) Co., Ltd. | 2021-03-24 |
| I-Q View (K203703) | First Source, Inc. | 2021-03-24 |
| Betta Link Knotless Implant System (K210498) | T.A.G. Medical Products Corporation, Ltd. | 2021-03-24 |
| Safety Subcutaneous Infusion Set (K201626) | Epic Medical Pte. , Ltd. | 2021-03-24 |
| Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color (K202080) | Shen Wei USA, Inc. | 2021-03-24 |
| TrueRelief Device (K202186) | Truerelief | 2021-03-23 |
| Viz ICH (K210209) | Viz. Ai, Inc. | 2021-03-23 |
| APOLLO Anterior Cervical Plate (ACP) System (K210325) | Aurora Spine, Inc. | 2021-03-23 |
| ICU Health Surgical Mask (K203064) | Plastikon Industries | 2021-03-23 |
| DIOnavi-Denture02 (K210828) | Dio Corporation | 2021-03-23 |
| Navigated Spine Instruments (K203205) | Stryker Spine | 2021-03-23 |
| LigaSure Exact Dissector, Nano-coated (K202917) | Covidien, LLC | 2021-03-23 |
| Harvester SI: Sacroiliac Fixation System (K203780) | Spinus International, Inc. | 2021-03-23 |
| Aneroid Sphygmomanometer (K203620) | Wuxi Exanovo Medical Instrument Co., Ltd. | 2021-03-23 |
| 7D Surgical System - Drill Guide (K210555) | 7D Surgical, Inc. | 2021-03-23 |