| Omnipod 5 ACE Pump (Pod) (K203768) | Insulet Corporation | 2022-01-27 |
| Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System (K213211) | Carolina Liquid Chemistries Corp. | 2022-01-27 |
| 9Line (K211941) | Energetic Designs, Inc. | 2022-01-27 |
| Omnipod 5 SmartBolus Calculator (K203772) | Insulet Corporation | 2022-01-27 |
| Merlin Aspiration System (K213771) | Mivi Neurovascular, Inc. | 2022-01-27 |
| Sterile Auto-Disable Syringes with/without Needle for Single Use (K211210) | Azur Medical Company, Inc. | 2022-01-27 |
| Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) (K210360) | Osteonic Co., Ltd. | 2022-01-27 |
| Elevo Snoring Intervention Set (K213475) | Zelegent, Inc. | 2022-01-27 |
| Fortilink with TiPlus Technology (K213493) | Paradigm Spine | 2022-01-27 |
| ANTHEM® Fracture System (K213591) | Globus Medical, Inc. | 2022-01-26 |
| LASSOSTAR NAV Circular Mapping Catheter (K211219) | Biosense Webster, Inc. | 2022-01-26 |
| American-Made Surgical Mask (K210101) | Armbrust, Inc. | 2022-01-26 |
| SternaFuse Fixation System (K202914) | Fusion Innovations, LLC | 2022-01-26 |
| LightStim Elipsa (K212771) | Led Intellectual Properties, LLC | 2022-01-26 |
| JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (K212868) | Rocamed Sam | 2022-01-26 |
| Surgical Face Mask (K212610) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-01-26 |
| Vitalograph Model 6000 Alpha (K212938) | Vitalograph Ireland, Ltd. | 2022-01-26 |
| SmoothSkin Pure Mini (K213692) | Cyden Limited | 2022-01-26 |
| INNO SLA Submerged Implant System (K201323) | Cowellmedi Co., Ltd. | 2022-01-25 |
| HDH Treatment Planning System (K212173) | Cdb Corporation | 2022-01-25 |
| ADI Medical Surgical Face Mask (K213347) | Asia Dynamics Inc., D/B/A Adi Medical | 2022-01-25 |
| iCare HOME2 (K211355) | Icare Finland OY | 2022-01-25 |
| Revaclear 500, Revaclear 400, Revaclear 300 (K213639) | Baxter Healthcare Corporation | 2022-01-24 |
| Disposable Syringe with Needle (K211482) | Shandong Qinkai Medical Industry Co., Ltd. | 2022-01-24 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (K212333) | Canon Medical Systems Corporation | 2022-01-24 |
| DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 (K213780) | Canon, Inc. | 2022-01-24 |
| Myflon Surgical Mask Level 3 (K212111) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-01-23 |
| Thermoplastic Elastomer (TPE) Hybrid Examination Glove (K210463) | Xuzhou Full Sun Medical Products , Ltd. | 2022-01-23 |
| Steiking Packaging for Medical Devices (K210810) | Wipak OY | 2022-01-23 |
| D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply (K213970) | Danameco Medical Joint Stock Corporation | 2022-01-23 |
| Abbott Medical Grounding Pad, model RF-DGP-IS (K203293) | ABBOTT MEDICAL | 2022-01-21 |
| PERLA® TL Posterior Osteosynthesis System (K213470) | Spineart | 2022-01-21 |
| Saremco Print CROWNTEC (K213343) | Saremco Dental AG | 2022-01-21 |
| Infrared Thermometer (K211752) | Beijing Choice Electronic Technology Co., Ltd. | 2022-01-21 |
| ParaMotion (K203761) | Powerbasetec GmbH | 2022-01-21 |
| b-ONE MOBIO Total Knee System (K213673) | B-One Ortho, Corp. | 2022-01-21 |
| OSSIOfiber® Staple (K212594) | OSSIO , Ltd. | 2022-01-21 |
| ETHICON Megadyne Electrosurgical Generator (K213696) | Megadyne Medical Products, Inc. | 2022-01-21 |
| POMC/PCSK1/LEPR CDx Panel (DEN200059) | Preventiongenetics, LLC | 2022-01-21 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K211864) | Siyang Jaysun Medtech Co., Ltd. | 2022-01-21 |
| e-Throne Folding Wheelchair, Model: ET-12F22 (K191105) | Golden Motor Technology Co., Ltd. | 2022-01-21 |
| VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM (K213412) | Steris Corparation | 2022-01-21 |
| Universal DR 1748 (K214030) | Konica Minolta Healthcare Americas, Inc. | 2022-01-21 |
| Nitrile Examination Gloves (K213044) | Jiangsu Huayuan Medical Technology Co., Ltd. | 2022-01-21 |
| Osteorevive (K212991) | Bone Solutions, Inc. | 2022-01-21 |
| Electric breast pump (K212884) | Dongguan Rongfeng Medical Co., Ltd. | 2022-01-20 |
| Porous Patella (K212941) | Encore Medical, L.P. Dba Djo Surgical | 2022-01-20 |
| Parkell Self-Adhesive Cement (K210259) | Parkell, Inc. | 2022-01-20 |
| KIDNEY ASSIST-transport (K211333) | Xvivo Perfusion AB | 2022-01-20 |
| Entuit PEG, Entuit PEGJ (K213356) | Wilson-Cook Medical, Inc. | 2022-01-20 |
| SIGNA PET/MR (K213709) | Ge Medical Systems, LLC | 2022-01-20 |
| SIGNA Hero (K213668) | Ge Healthcare (Ge Medical Systems, LLC) | 2022-01-20 |
| syngo.CT Extended Functionality (K214019) | Siemens Medical Solutions USA, Inc. | 2022-01-20 |
| hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K214084) | Cefla S.C. | 2022-01-20 |
| Goody Gloves, Wincare, TBG Gloves (K213075) | Thai Rubber Gloves Co., Ltd. | 2022-01-20 |
| Surgical isolation gown (K212357) | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 |
| Disposable Dual Action Tissue Clip (K212748) | Micro-Tech (Nanjing) Co., Ltd. | 2022-01-20 |
| Surgical Face Mask (K203161) | Wuhan Raytex Protection Co., Ltd. | 2022-01-20 |
| Flexible Video-Uretero-Renoscope SSU System (K212458) | Karl Storz Endoscopy America | 2022-01-20 |
| Gas-Chex Indicator (K212592) | Propper Manufacturing Co., Inc. | 2022-01-20 |
| SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove (K211003) | Showa Best Glove, Inc. | 2022-01-19 |
| 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory (K213438) | Adaptiiv | 2022-01-19 |
| Biotres (K211709) | Biotricity | 2022-01-19 |
| Disposable Medical Mask (K212826) | Jiangsu Nanfang Medical Co., Ltd. | 2022-01-19 |
| GLOBAL ICON Stemless Shoulder System (K212683) | Depuy(Ireland) | 2022-01-19 |
| MDx-Chex for BCID2 (K212576) | Streck, Inc. | 2022-01-19 |
| Celeris, Disposable Sinus Debrider (K212650) | Gyrus Acmi, Inc. | 2022-01-19 |
| VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (K212581) | Stryker GmbH | 2022-01-19 |
| R3 Large Head Liners (K211330) | Smith & Nephew, Inc. | 2022-01-19 |
| Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 (K211532) | Yibin Junxin Electronics Technology Co., Ltd. | 2022-01-19 |
| Franz Zirconia Dental Crown (K203072) | Franz Biotech, Inc. | 2022-01-19 |
| Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) (K213227) | Uweport, LLC | 2022-01-19 |
| Stern Fix Sternal Stabilization System (K211613) | Neos Surgery S.L | 2022-01-19 |
| Caption Interpretation Automated Ejection Fraction Software (K210747) | Caption Health | 2022-01-19 |
| CoreLink Navigation Instruments (K214059) | Corelink, LLC | 2022-01-19 |
| Follicle Clarity (K212012) | Cycle Clarity | 2022-01-19 |
| Jabra Enhance Plus (K213424) | GN Hearing A/S | 2022-01-19 |
| LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. (K213447) | Shenzhen Cosbeauty Technology Co., Ltd. | 2022-01-19 |
| Air compression leg massager HY-1117A (K212713) | Xiamen High Top Electronic Technology Co., Ltd. | 2022-01-18 |
| ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP (K213781) | Depuy Ireland UC | 2022-01-18 |
| Medical Face Mask (K210679) | Wuxi Yushou Medical Appliances Co., Ltd. | 2022-01-18 |
| CHIRANA Insulin Syringes (K201044) | Chirana T. Injecta | 2022-01-18 |
| Microvolume Luer Access Device (K212842) | B.Braun Medical, Inc. | 2022-01-18 |
| JuniOrtho Plating System™ (K213572) | Orthofix Srl | 2022-01-18 |
| HP458E Electrically Powered Wheelchair (K212503) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2022-01-18 |
| Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (K213216) | Unicon Optical Co., Ltd. | 2022-01-18 |
| Medical Face Mask (K212994) | Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. | 2022-01-17 |
| Disposable Medical Face Mask (K211833) | Zhejiang the Purples Protective Products Co.,Ltd | 2022-01-16 |
| Kangbeier Surgical Mask (Model: KBR-1001) (K213920) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2022-01-16 |
| SIGNA Prime (K211980) | Ge Healthcare (Tianjin) Company Limited | 2022-01-16 |
| Precision Align (K212772) | Precision Align, LLC | 2022-01-15 |
| Disposable Nitrile Powder Free Examination Gloves (Non-sterile) (K211360) | Pt. Universal Gloves | 2022-01-15 |
| Respiratory Gating for Scanners v2.0 (K213927) | Varian Medical Systems, Inc. | 2022-01-14 |
| Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing (K202783) | Smith & Nephew Medical Limited | 2022-01-14 |
| Silver Gelling Fiber Dressing (K210466) | Winner Medical Co., Ltd. | 2022-01-14 |
| Wellead Endoscopic Seal (K211814) | Well Lead Medical Co., Ltd. | 2022-01-14 |
| Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (K213602) | Covidien, LLC | 2022-01-14 |
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) | Boston Scientific Corporation | 2022-01-14 |
| ARAI Surgical Navigation System (K211254) | Surgalign Spine Technologies | 2022-01-14 |
| Capsule Surveillance System (K213335) | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 |