| TULSA-PRO System (K211858) | Profound Medical, Inc. | 2022-09-06 |
| LiverMultiScan v5 (LMSv5) (K213960) | Perspectum | 2022-09-06 |
| Spectrum IQ Infusion System with Dose IQ Safety Software (K222048) | Baxter Healthcare Corporation | 2022-09-06 |
| EMPHASYS Acetabular System (K221636) | Depuy Ireland UC | 2022-09-06 |
| Smith+Nephew INTELLIO Tablet (K221929) | Smith+Nephew | 2022-09-06 |
| Ez3D-i/E3 (K222069) | Ewoosoft Co., Ltd. | 2022-09-06 |
| ASAHI Gladius Mongo18 PV ES (K213868) | Asahi Intecc Co., Ltd. | 2022-09-06 |
| Hammertoe Truss System (HTS) (K221283) | 4Web Medical, Inc. | 2022-09-06 |
| ROTAPRO Rotational Atherectomy System (K220962) | Boston Scientific Corporation | 2022-09-06 |
| Neodent Implant System - GM Narrow Implant System (K220251) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2022-09-06 |
| Arrow Pressure Injectable Midline Catheter (K213855) | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022-09-02 |
| DURAMESH Mesh Suture (K211178) | Msi | 2022-09-02 |
| Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K213983) | Yung Sheng Optical Co., Ltd. | 2022-09-02 |
| Visera Hysterovideoscope Olympus HYF Type V (K221557) | Olympus Medical Systems Corporation | 2022-09-02 |
| Camber Sacroiliac (SI) Fixation System (K203503) | Camber Spine Technologies, LLC | 2022-09-02 |
| Soniquence Reusable 3 Button Fingerswitch Wand (K212222) | Soniquence, LLC | 2022-09-02 |
| ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter (K221414) | Silk Road Medical, Inc. | 2022-09-02 |
| Mygen M-3004 RF Generator M-3004 (K221277) | RF Medical Co., Ltd. | 2022-09-02 |
| CellFX System (K222075) | Pulse Biosciences, Inc. | 2022-09-02 |
| Synthetic Bone Putty (K221644) | Ventris Medical | 2022-09-02 |
| Bonebridge Osteosynthesis Plating System (K213864) | Bonebridge AG | 2022-09-02 |
| FibroLux (K212189) | Multi Radiance Medical | 2022-09-02 |
| StageOne Knee Cement Spacer Molds (K213287) | Biomet, Inc. | 2022-09-02 |
| Savewo ClassicMASK (K221957) | Savewo Limited | 2022-09-02 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |
| Perfetta Moderate Medical Face Mask (K222426) | Phu Bao Group Company Limited | 2022-09-02 |
| LiNA OperaScope Needle (K221085) | Lina Medical Aps | 2022-09-02 |
| FOX 810, FOX 980 (K220531) | A.R.C Laser GmbH | 2022-09-01 |
| Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K (K220177) | Magnus Medical, Inc. | 2022-09-01 |
| DrAid for Radiology v1 (K221241) | Vinbrain Joint Stock Company | 2022-09-01 |
| Disposable Medical Masks (K221038) | Hantech Medical Device Co., Ltd. | 2022-09-01 |
| Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System (K220563) | ArthroCare Corporation | 2022-09-01 |
| Soteria Bed Barrier (K201876) | Trinity Guardion | 2022-09-01 |
| Wireless TENS/EMS, Bruno, Aela (K220997) | Zmi Elecronics , Ltd. | 2022-09-01 |
| Knee+ (K220104) | Pixee Medical | 2022-09-01 |
| Erchonia GVL (K221987) | Erchonia Corporation | 2022-09-01 |
| Hybrid C70 (K220579) | Digimed Co., Ltd. | 2022-09-01 |
| Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) (K221040) | Jiangxi Aicare Medical Technology Co., Ltd. | 2022-08-31 |
| SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (K221255) | Kerr Corporation | 2022-08-31 |
| Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (K221955) | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022-08-31 |
| Disposable Blood Lancet (K221507) | SteriLance Medical (Suzhou), Inc. | 2022-08-31 |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K222387) | Canon Medical Systems Corporation | 2022-08-31 |
| MyClearALIGN Dental Aligner System (K221475) | Key Dental Technologies, LLC | 2022-08-31 |
| INHANCETM Reverse Glenoid Peripheral Posts (K221467) | Depuy Ireland UC | 2022-08-31 |
| IPL sapphire ice cooling hair remove device (K221635) | Shenzhen Desida Technology Co., Ltd. | 2022-08-31 |
| LimFlow ARC (K221541) | LimFlow, Inc. | 2022-08-31 |
| I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935) | I.T.S. GmbH | 2022-08-31 |
| Sterile Posterior Spinal Fixation System (K221745) | Shanghai Reach Medical Instrument Co, Ltd. | 2022-08-31 |
| QT Scanner 2000 Model A (K220933) | Qt Imaging, Inc. | 2022-08-31 |
| Vented Vial Adapter 20mm (K213513) | West Pharma. Services IL, Ltd. | 2022-08-31 |
| 8ch Wrist Coil (K222325) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-31 |
| Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx (K221871) | Healstone Biotech, Inc. | 2022-08-30 |
| JR Medic (K221157) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-08-30 |
| Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use (K212846) | Jiangsu Jichun Medical Devices Co., Ltd. | 2022-08-30 |
| Ultrasound Transmission Gels (K221999) | Hony Medical Co., Ltd. | 2022-08-30 |
| Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System (K221618) | Brainlab AG | 2022-08-30 |
| INDEX BPM (K221486) | Ya Horng Electronic Co., Ltd. | 2022-08-30 |
| Dose IQ Safety Software (K211124) | Baxter Healthcare Corporation | 2022-08-30 |
| Lancing device (K221970) | SteriLance Medical (Suzhou), Inc. | 2022-08-30 |
| Medical Surgery Mask, Model:2626-7 (K220067) | Dongguan Missadola Technology Co., Ltd. | 2022-08-30 |
| Riva Cem Automix (K214118) | Sdi Limited | 2022-08-30 |
| Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl (K221164) | Hong Seng Gloves Sdn Bhd | 2022-08-30 |
| Arrow Stiffening Stylet (K220280) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K222558) | Centers for Disease Control and Prevention | 2022-08-30 |
| SOL-GUARD Safety Pull Button Collection Set (K213718) | Sol-Millennium Medical, Inc. | 2022-08-30 |
| SaliPen (K220618) | Saliwell , Ltd. | 2022-08-30 |
| Novum IQ Syringe Pump (K211125) | Baxter Healthcare Corporation | 2022-08-30 |
| Leaderflex Mini and Leaderflex Nano (K212370) | Vygon USA | 2022-08-29 |
| Viz RV/LV (K221100) | Viz. Ai, Inc. | 2022-08-29 |
| GlucoLeader Enhance 2 Blood Glucose Monitoring System (K212248) | Hmd Biomedical, Inc. | 2022-08-29 |
| K-SHIELD Zen (K220799) | Sb-Kawasumi Laboratories, Inc. | 2022-08-29 |
| Blood Pressure Monitor (K220676) | Guangdong Transtek Medical Electronics Co., Ltd. | 2022-08-29 |
| Non-Mydriatic Retinal Camera NW500 (K221111) | Topcon Corporation | 2022-08-29 |
| Salvo® Spine System (K222362) | Spine Wave, Inc. | 2022-08-29 |
| Rusch Intermittent Urethral Catheters (K222279) | Teleflex Medical | 2022-08-29 |
| TCL3 Motion Tracking System (K221785) | Tracinnovations A/S | 2022-08-29 |
| OLIZ LTB-1000A (K221189) | Ltbio Co., Ltd. | 2022-08-29 |
| Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) (K222449) | Better Care Plastic Technology Co., Ltd. | 2022-08-27 |
| MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357) | Medcad | 2022-08-26 |
| Upper Arm Blood Pressure Monitor (K221212) | Shenzhen Yolanda Technology Co., Ltd. | 2022-08-26 |
| HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (K220875) | Innovasis, Inc. | 2022-08-26 |
| LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation (K222278) | Corentec Co., Ltd. | 2022-08-26 |
| NEOVEIL Staple Line Reinforcement (K221487) | Gunze Limited | 2022-08-26 |
| Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer (K214058) | Conmed Corporation | 2022-08-26 |
| Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) (K220159) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 |
| BrainsWay Deep TMS System (K220819) | Brainsway , Ltd. | 2022-08-26 |
| Arthrex Self Punching SwiveLock Suture Anchors (K222263) | Arthrex, Inc. | 2022-08-26 |
| BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256) | Neo Medical SA | 2022-08-26 |
| Vibrant System (DEN210052) | Vibrant, Ltd. | 2022-08-26 |
| Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (K220262) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 |
| StimOnTM Pain Relief System (GM2439) (K213802) | Gimer Medical Co., Ltd. | 2022-08-26 |
| BriefCase (K222277) | Aidoc Medical , Ltd. | 2022-08-26 |
| Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091) | Xiros, Ltd. | 2022-08-26 |
| LapBox Tissue Containment Removal System (K221365) | Ark Surgical, Ltd. | 2022-08-25 |
| GlucoSure Link Blood Glucose Monitoring System (K212140) | Apex BioTechnology Corp. | 2022-08-25 |
| Nitrile Exam Gloves (Blue, Black) (K221143) | Hebei Astro Medical Supply Co., Ltd. | 2022-08-25 |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222543) | Steris | 2022-08-25 |
| Acute QC Strut and Components (K221792) | Smith & Nephew, Inc. | 2022-08-25 |
| WiEMSpro (K211298) | Medical Cables S.L. | 2022-08-25 |
| Disposable, vinyl examination gloves, Yellow (K220055) | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-08-25 |