| Oxyfit Pulse Oximeter (K203812) | Shenzhen Viatom Technology Co., Ltd. | 2022-11-08 |
| Hisense LCD monitor HMD2G21S, HMD3G21S (K222132) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-08 |
| Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (K222734) | Diversatek Healthcare | 2022-11-08 |
| EFAI ChestSuite XR Pneumothorax Assessment System (K221552) | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module (K221833) | Edwards Lifesciences, LLC | 2022-11-07 |
| Smooth Drive contra angle and straight handpieces (K220874) | Lares Research | 2022-11-07 |
| Durex Patronus CloseFit, Durex Patronus Regular (K220489) | Rb Health (Us), LLC | 2022-11-07 |
| WaveForm A Interbody System (K222732) | SeaSpine Orthopedics Corporation | 2022-11-07 |
| Vericor Support Catheter (K222679) | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (K222873) | Medtronic | 2022-11-07 |
| Lotus Prophy Angle (K220346) | Ajk Engineering, Inc. | 2022-11-07 |
| Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) (K222800) | Sanhe Laserconn Tech Co., Ltd. | 2022-11-07 |
| Humeris® 135 Shoulder System (K222936) | Fx Shoulder USA, Inc. | 2022-11-07 |
| Eclipse MINI Model 98900 (K212317) | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (K223127) | Edwards Lifeciences, LLC | 2022-11-07 |
| DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741) | Hdi, Inc. | 2022-11-07 |
| SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (K222898) | Safesource Direct, LLC | 2022-11-07 |
| Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (K202755) | Diasorin Molecular, LLC | 2022-11-05 |
| Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL (K220833) | Acuitive Technologies, Inc. | 2022-11-04 |
| VHA Radiotherapy Bolus (K222639) | Vha Dean | 2022-11-04 |
| Medwell Technology Ltd Syringes, various sizes (K212764) | Medwell Technology, Ltd. | 2022-11-04 |
| CryoRobot Select System (K221086) | Tmrw Life Sciences, Inc. | 2022-11-04 |
| Luminopia One (K221659) | Luminopia, Inc. | 2022-11-04 |
| Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle (K222124) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-11-04 |
| BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (K220421) | Apex BioTechnology Corp. | 2022-11-04 |
| Yomi Robotic System (K222049) | Neocis, Inc. | 2022-11-04 |
| Disposable Medical Face Mask (DF3-001) (K222697) | Wellmed Dental Medical Supply Co., Ltd. | 2022-11-04 |
| cobas HCV (K221007) | Roche Molecular Systems, Inc. | 2022-11-04 |
| Self-adhesive Electrode (K222453) | Guangdong Comytens Medical Technology Co., Ltd. | 2022-11-04 |
| BENCHMARK BMX81 Access System (K221822) | Penumbra, Inc. | 2022-11-04 |
| Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (K201256) | Procise Diagnostics | 2022-11-04 |
| Humerus & Ulna System (K213108) | Auxein Medical Private Limited | 2022-11-04 |
| World Total Knee System (K223062) | Signature Orthopaedics Pty, Ltd. | 2022-11-04 |
| United U2 femoral head, 22mm delta ceramic head (K221675) | United Orthopedic Corporation | 2022-11-04 |
| Nextra CH Cannulated Hammertoe System (K221610) | Nextremity Solutions, Inc. | 2022-11-04 |
| UniVy OsteoVy Cervical IBF System (K221162) | Vy Spine, LLC | 2022-11-04 |
| Aquilo Sports CCT1500 System (K223164) | Aquilo Sports, LLC | 2022-11-04 |
| Led Mask Platinum Md (K222377) | Cellreturn Co., Ltd. | 2022-11-03 |
| ibiomedi Electronic Stethoscope ES-2020 (K220466) | Sound Land Corp. | 2022-11-03 |
| NP Medical nCompass Extension Set with Stabilizing Base (K221518) | Np Medical | 2022-11-03 |
| Insulin Syringes without needle (K221045) | Berpu Medical Technology Co., Ltd. | 2022-11-03 |
| Tera Harz Clear (K223355) | Graphy, Inc. | 2022-11-03 |
| Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers (K220263) | Vortex Surgical, Inc. | 2022-11-03 |
| Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler (K222168) | Owen Mumford, Ltd. | 2022-11-03 |
| ABTross ALIF Expandable Cage System (K221719) | Aegis Spine, Inc. | 2022-11-03 |
| Black Diamond™ POCT Spinal System (K222107) | Osseus Fusion Systems | 2022-11-03 |
| truSculpt iD (K223110) | Cutera, Inc. | 2022-11-03 |
| Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220371) | Summit Glove, Inc. | 2022-11-02 |
| Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K211816) | Brightway Holdings Sdn. Bhd. | 2022-11-02 |
| Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223320) | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2022-11-02 |
| OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie (K222084) | Asahi Polyslider Co., Ltd. | 2022-11-02 |
| ORiGO System (K221184) | Bien-Air Surgery SA | 2022-11-02 |
| Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (K222395) | Ellex Medical Pty, Ltd. | 2022-11-02 |
| Dolphin Blue Imaging (K221478) | Patterson Dental Supply, Inc. | 2022-11-01 |
| Back 3 COLOR (K214090) | Swims America Corp | 2022-11-01 |
| Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle (K221247) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 |
| Combined High Frequency X-ray Source (K222258) | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 |
| Klarity SRS Baseplate, Klarity Promise Baseplate (K220539) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2022-11-01 |
| 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K222508) | 3M Company | 2022-11-01 |
| Current Health System (K222550) | Current Health , Ltd. | 2022-11-01 |
| POSE™ Health Care Surgical Mask (K223270) | America'S Supply Chains | 2022-11-01 |
| IO Needle Safety Sheath (K220890) | Actuated Medical, Inc. | 2022-10-31 |
| CW60N (K222722) | Wide Corporation | 2022-10-31 |
| Fresenius Liberty Select Cycler (K222318) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 |
| LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (K221810) | Bonraybio Co., Ltd. | 2022-10-31 |
| CL24N (K222717) | Wide Corporation | 2022-10-31 |
| Standard Tapered Bougie, 38 Fr. (K222085) | Standard Bariatrics, Inc. | 2022-10-31 |
| Excelsior (K220929) | Merit Cro, Inc. | 2022-10-31 |
| ORiGO System (K213697) | Bien-Air Surgery SA | 2022-10-31 |
| Nuheara IQbuds 2 PRO Hearing Aid (K221064) | Nuheara Limited | 2022-10-30 |
| Stage (K223079) | Spintech, Inc. | 2022-10-28 |
| Stela Capsule System (K222583) | Sdi Limited | 2022-10-28 |
| Welch Allyn Connex Central Station (K212473) | Welch Allyn, Inc. | 2022-10-28 |
| Remi Robotic Navigation System (K223070) | Fusion Robotics, LLC | 2022-10-28 |
| Bakri Essential Postpartum Balloon (K223098) | Cook Incorporated | 2022-10-28 |
| Vapotherm Aerosol Adapter AAA-2 (K220869) | Vapotherm, Inc. | 2022-10-28 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (K214109) | Kontour(Xi’An) Medical Technology Co., Ltd. | 2022-10-28 |
| VS3-Iridium System (VS3-IR) (K223020) | Visionsense, Ltd. | 2022-10-28 |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (K222653) | Smith+Nephew, Inc. | 2022-10-28 |
| Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 (K222191) | Supersonic Imagine | 2022-10-28 |
| Stela Automix System (K222581) | Sdi Limited | 2022-10-28 |
| SUPERTILT PLUS (STP) (K221435) | Power Plus Mobility | 2022-10-28 |
| Disposable Safety Lancet (K221521) | SteriLance Medical (Suzhou), Inc. | 2022-10-28 |
| Disposable Surgical Gown Rk-3011C (K211060) | Xiantao Rhycom Non-Woven Products Co., Ltd. | 2022-10-28 |
| Spinal Inner Fixation System (K222031) | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2022-10-28 |
| Non Sterile Powder Free Latex Examination Glove (K221667) | New Era Medicare Sdn. Bhd. | 2022-10-28 |
| Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305) | Syntheon | 2022-10-28 |
| ALLY II Uterine Positioning System™ (UPS) (K223064) | CooperSurgical, Inc. | 2022-10-28 |
| Architect CMV IgG (K220949) | Abbott Laboratories | 2022-10-27 |
| ORAcollect®•Dx (K212745) | DNA Genotek, Inc. | 2022-10-27 |
| Mobility+ Enteral Feeding System (K222678) | Rockfield Medical | 2022-10-27 |
| S.I.N. Dental Implant System (K222231) | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-10-27 |
| HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System (K222282) | Hospital Equipment Manufacturing Company | 2022-10-27 |
| CUSTMBITE Snoring System (K221322) | Dental Choice Holdings, LLC | 2022-10-27 |
| JR MEDIC (K222348) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-27 |
| DESS Dental Smart Solutions (K222288) | Terrats Medical SL | 2022-10-27 |
| 2008T BlueStar Hemodailysis Machine (K222952) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 |
| uMR Omega with uWS-MR-MRS (K220332) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-27 |
| AlphaID™ At Home Genetic Health Risk Service (K221420) | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 |
| S.I.N. Instrument Kits (K222514) | S.I.N. – Sistema DE Implante Nacional S.A. | 2022-10-27 |