| WavelinQ™ Generator (K222793) | C.R. Bard, Inc. | 2022-10-17 |
| YUWELL Electronic Blood Pressure Monitor (K221372) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-10-17 |
| Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175) | Arkray, Inc. | 2022-10-17 |
| Standalone ALIF Interbody Fusion System (K221936) | Eminent Spine | 2022-10-17 |
| Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K221308) | Jiangxi Maidikang Medical Devices Co., Ltd. | 2022-10-17 |
| Zimmer Persona Personalized Knee System (K222566) | Zimmer, Inc. | 2022-10-17 |
| Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (K221014) | Effortless Oxygen, LLC | 2022-10-17 |
| Digital Radiography CXDI-Pro, Digital Radiography D1 (K222855) | Canon, Inc. | 2022-10-17 |
| AcQMap High Resolution Imaging and Mapping System (K222209) | Acutus Medical, Inc. | 2022-10-17 |
| Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves (K222074) | Zibo Langu New Material Technology Co., Ltd. | 2022-10-17 |
| ATTUNE Revision Cones (K212746) | Depuy Ireland UC | 2022-10-17 |
| CASSATT™ SIJ Fixation System (K211785) | Ctl Medical Corporation | 2022-10-17 |
| Mobility Scooter, Model: W3331F (K222495) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-10-17 |
| Pulse Oximeter (Model C101A2, C101B1, C101A3) (K221979) | Shenzhen Imdk Medical Technology Co., Ltd. | 2022-10-16 |
| SafeBreak Vascular (K222791) | Lineus Medical, LLC | 2022-10-16 |
| LUDWIG Electrosurgical Device (K221574) | Aesthetics Biomedical | 2022-10-16 |
| STIMPOD NMS450 Nerve Stimulator (K213049) | Xavant Technology (Pty), Ltd. | 2022-10-16 |
| CONDUIT Cages; FIBERGRAFT BG Putty (K222276) | Depuy Spine | 2022-10-15 |
| CoreLevee (K213748) | Lutronic Corporation | 2022-10-14 |
| TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (K214054) | Tp Orthodontics, Inc. | 2022-10-14 |
| X-CUBE 70, X-CUBE 90 (K221093) | Alpinion Medical Systems Co., Ltd. | 2022-10-14 |
| Southern Anterior Screw Fixated Cage (SASCA) (K221447) | Southern Medical (Pty) , Ltd. | 2022-10-14 |
| Tornier Perform Humeral System – Fracture (K220914) | Tornier, Inc. | 2022-10-14 |
| Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (K221840) | Integra Lifesciences Production Corporation | 2022-10-14 |
| Safety Insulin Pen Needles (K213183) | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-10-14 |
| 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil (K222407) | Neocoil, LLC | 2022-10-14 |
| X-Pac Expandable Lumbar Cage System (K222797) | Expanding Innovations, Inc. | 2022-10-14 |
| The Cooral System (DEN210027) | Braincool AB | 2022-10-14 |
| Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) (K222284) | Applied Medical Resources Corporation | 2022-10-14 |
| PAL Infiltration System (K220318) | Microaire Surgical Instruments, LLC | 2022-10-14 |
| IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi (K222537) | Shenzhen Ishine Technology Company Limited | 2022-10-14 |
| AI-Rad Companion Organs RT (K221305) | Siemens Medical Solutions USA, Inc. | 2022-10-14 |
| Shoulder PacemakerTM (K220994) | Ncs Lab Srl | 2022-10-14 |
| BD Surgiphor™ Antimicrobial Irrigation System (K221504) | Bd | 2022-10-14 |
| Vitrea CT Cardiac Analysis (K222662) | Canon Medical Informatics, Inc. | 2022-10-14 |
| HeartFlow Analysis (K213857) | HeartFlow, Inc. | 2022-10-14 |
| FOCUS Interbody System (K221172) | Oc Medical Devices | 2022-10-14 |
| ZSFab Lumbar Interbody System (K221858) | Zsfab, Inc. | 2022-10-14 |
| syngo.via View&GO (K221501) | Siemens Healthcare GmbH | 2022-10-14 |
| Sublime Microcatheter (K221886) | Surmodics,Inc. | 2022-10-14 |
| EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods (K222473) | Medos-International Sarl | 2022-10-13 |
| ID-510 iRestore Elite (K222081) | Freedom Laser Therapy, Inc. | 2022-10-13 |
| The Oligio (K221989) | Wontech Co., Ltd. | 2022-10-13 |
| CREOKORREKT Aligners (K211427) | Creodent Prosthetics, Ltd. | 2022-10-13 |
| Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (K222763) | Responsive Arthroscopy, LLC | 2022-10-13 |
| SPIFE A1AT kit (K213396) | Helena Laboratories, Corp. | 2022-10-13 |
| VITEK 2 AST-Gram Positive Cefoxitin Screen (K220805) | bioMerieux, Inc. | 2022-10-13 |
| PicoWay Laser System (K220853) | Candela Corporation | 2022-10-13 |
| allFlex Ureteral Catheters, Krait Ureteral Catheters (K220730) | Allwin Medical Devices, Inc. | 2022-10-13 |
| UNITY Sacroiliac Joint Fixation System (K222448) | Dio Medical Corporation | 2022-10-13 |
| IM/ST Fixture System (K212702) | Guilin Fiteeth Medical Instrument Co., Ltd. | 2022-10-13 |
| SCIg60 Infusion System (K222087) | Emed Technologies Corporation | 2022-10-13 |
| X-CUBE 50, X-CUBE 60 (K220857) | Alpinion Medical Systems Co., Ltd. | 2022-10-13 |
| Fiber Laser Treatment System (K221770) | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 |
| Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) (K211321) | Guangzhou Sonostar Technologies Co., Ltd. | 2022-10-13 |
| Abiomed 14Fr Low Profile Introducer Set (K222113) | Abiomed, Inc. | 2022-10-13 |
| Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 (K221857) | Zhejiang Lude Technology Development Co., Ltd. | 2022-10-13 |
| AT-Patch ECG Analysis System (K203638) | Atsens Co., Ltd. | 2022-10-12 |
| Ameda Pearl Electric Breast Pump (K221576) | Ameda, Inc. | 2022-10-12 |
| Elecsys CMV IgG (K220911) | Roche Diagnostics | 2022-10-12 |
| PiezoImplant System (K211872) | Rex Implants, Inc. | 2022-10-12 |
| Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (K221712) | Fotona D.O.O. | 2022-10-12 |
| Auto Folding Scooter, S21F (K220227) | Heartway Medical Products Co., Ltd. | 2022-10-12 |
| Durex Penck III Regular (K222068) | Rb Health (Us), LLC | 2022-10-12 |
| Aqua Naina Plus Sterile Saline Solution (K221263) | Chemtex USA, Inc. | 2022-10-12 |
| OW100S (model OW100S-US) (K213120) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022-10-12 |
| Elecsys HSV-2 IgG (08948887160) (K220924) | Roche Diagnostics | 2022-10-12 |
| The Alma Soprano Titanium (K222064) | Alma Lasers, Inc. | 2022-10-12 |
| Arm Blood Pressure Monitor (K221913) | Alicn Medical Shenzhen, Inc. | 2022-10-12 |
| Elecsys HSV-1 IgG (08948844160) (K220923) | Roche Diagnostics | 2022-10-12 |
| MOST-T Autoclave (K220102) | Shinva Medical Instrument Co., Ltd. | 2022-10-12 |
| TrusFIL-Flow Flowable Composite Restorative (K221510) | Rizhao Huge Biomaterials Company, Ltd. | 2022-10-12 |
| Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K222079) | Stryker Endoscopy | 2022-10-11 |
| Branchor Balloon Guide Catheter (K221951) | Asahi Intecc Co., Ltd. | 2022-10-11 |
| Renamel® Microhybrid ;Renamel® Flowable Microhybrid (K222435) | Cosmedent, Inc. | 2022-10-11 |
| Apyx One Console (K221830) | Apyx Medical Corporation | 2022-10-11 |
| IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 (K222432) | Hunan Guangye Biotechnology Co., Ltd. | 2022-10-11 |
| ECHO Photocoagulator (K222157) | Norlase | 2022-10-11 |
| SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (K220169) | Bionet Co., Ltd. | 2022-10-11 |
| Surgical Mask (K222335) | Luoyang Sunmed Devices Co., Ltd. | 2022-10-11 |
| Sol-M Luer Lock Syringe (K222744) | Sol-Millennium Medical, Inc. | 2022-10-11 |
| AAMI4 Isolation Gown (K214116) | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 |
| Disposable Vinyl Examination Gloves (K223008) | Jiangxi Handspro Products Solutions Co., Ltd. | 2022-10-08 |
| Infant Heel WarmerTM; Heel Snuggler® (K221154) | International Biomedical | 2022-10-07 |
| Protect-It Custom Fit Dental Guard (K222424) | Doc Brands, Inc. | 2022-10-07 |
| MIM-Ablation (K220256) | Mim Software, Inc. | 2022-10-07 |
| Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps (K213610) | Katalyst Surgical, LLC | 2022-10-07 |
| YADU Surgical Gowns (K220092) | Henan Yadu Industrial Co., Ltd. | 2022-10-07 |
| Mico One Orthodontic Screw (K202163) | Ze Fang Technology Co., Ltd. | 2022-10-07 |
| InBody Blood pressure monitor, Model BPBIO480KV (K221764) | Inbody Co., Ltd. | 2022-10-07 |
| AMSafe NeuFlo Needleless Connector (K220267) | Amsino International, Inc. | 2022-10-07 |
| SteriTite Container System with MediTray Parts (K221492) | Case Medical, Inc. | 2022-10-07 |
| BriefCase (K220709) | Aidoc Medical , Ltd. | 2022-10-07 |
| Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K222714) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-10-07 |
| Nuvola (K222418) | Gruppo Europeo Ortodonzia Srl | 2022-10-07 |
| IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (K222028) | Alphatec Spine | 2022-10-07 |
| Cold Sore Device (Model: QPZ-01) (K222205) | Light Tree Ventures Europe B.V. | 2022-10-07 |
| VisionAir Patient-Specific Airway Stent (K213969) | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| CUVIS-spine (K222698) | Curexo, Inc. | 2022-10-07 |
| RespiraSense (K220111) | Pmd Solutions | 2022-10-07 |