| EL CAPITAN Anterior Lumbar Interbody Fusion System (K214047) | Astura Medical | 2022-03-30 |
| EON (K211681) | Dominion Aesthetic Technologies, Inc. | 2022-03-30 |
| INTAI Surgical Mask (non-sterile) (K210422) | Intai Technology Corp. | 2022-03-30 |
| Empulse R90 (K220213) | Sunrise Medical (Us), LLC | 2022-03-30 |
| VERIQA (K213370) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022-03-30 |
| Aggeris™-C (K220182) | Clariance | 2022-03-30 |
| CareTaker Monitor App (K213699) | Caretaker Medical, LLC | 2022-03-30 |
| Dukal Corporation AAMI Level 4 Open-Back Protective Gown (K212464) | Dukal Corporation | 2022-03-30 |
| VSP Bolus (K214093) | 3D Systems | 2022-03-30 |
| Dukal Corporation Level 1 Pediatric Face Mask (K210321) | Dukal Corporation | 2022-03-29 |
| Reliance Cervical IBF System (K202266) | Reliance Medical Systems, LLC | 2022-03-29 |
| GAL-1A Plus Blood Glucose Monitoring System (K213887) | Apex BioTechnology Corp. | 2022-03-29 |
| REAL INTELLIGENCE CORI (K220255) | Blue Belt Technologies, Inc. | 2022-03-29 |
| Focus HD 43 Detector (K213529) | Iray Technology Taicang , Ltd. | 2022-03-29 |
| Focus HD 35 Detector (K213646) | Iray Technology Taicang , Ltd. | 2022-03-29 |
| Guidewire Locking Device (K220247) | Micro-Tech (Nanjing) Co., Ltd. | 2022-03-29 |
| BrainTemp Neonate System (BTNeo System) (DEN200042) | Brain Temp, Inc. | 2022-03-29 |
| CERABIEN MiLai (K213147) | Kuraray Noritake Dental, Inc. | 2022-03-28 |
| Syngo.CT Dual Energy (K212889) | Siemens Medical Solutions USA, Inc. | 2022-03-28 |
| SancDam Latex Oral Dam (K212037) | Sanctuary Health Sdn. Bhd. | 2022-03-28 |
| OSSIOfiber Suture Anchor (K213415) | OSSIO , Ltd. | 2022-03-28 |
| Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) (K213662) | Taishan Weibang Medical Equipment Co., Ltd. | 2022-03-28 |
| Hand-held IPL device(JOVS Graphene Hair Removal Device) (K214113) | Shenzhen Qianyu Technology Co., Ltd. | 2022-03-28 |
| T3 Pro Implants (K213672) | Biomet 3i, LLC | 2022-03-28 |
| GGM Breathing Circuit Bacterial Filter (K210352) | Great Group Medical Co, Ltd. | 2022-03-27 |
| Clover Glove (K213729) | Clover Glove Company Limited | 2022-03-26 |
| Powder Free Nitrile Examination Gloves, Orange (K220229) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2022-03-26 |
| Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) (K220215) | Ksg Medicare Sdn. Bhd. | 2022-03-26 |
| Toro-L Interbody Fusion System (K213355) | Integrity Implants, Inc. | 2022-03-25 |
| Medical Surgical Mask (Model: JM92, JM92B) (K220187) | Guangdong Jia Mei Biological Technology Co.Ltd | 2022-03-25 |
| C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor (K212231) | Nanjing Jusha Display Technology Co., Ltd. | 2022-03-25 |
| Pluski Safe 1 Safety IV Catheter (K210037) | Mediplus (India) Limited | 2022-03-25 |
| Infusion Sets for Single Use (K202437) | Jiangsu Suyun Medical Materials Co., Ltd. | 2022-03-25 |
| Biobeat Platform, BB-613WP Patch (K212153) | Biobeat Technologies , Ltd. | 2022-03-25 |
| Artix Thrombectomy Device (K220600) | Inari Medical | 2022-03-25 |
| Medical nitrile examination gloves (Model: JL001) (K213848) | Guangdong Jiali Pharmaceutical Co.,Ltd | 2022-03-25 |
| 3 Ply Medical Grade Single Use Procedural Disposable Face Mask (K220637) | Kdi Med Supply | 2022-03-25 |
| LE-12CH (K220362) | Caf Medical Solutions, Inc. | 2022-03-25 |
| Nebulizer (K212395) | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 |
| Luna G3 BPAP System (K212263) | 3B Medical, Inc. | 2022-03-25 |
| DTX Studio Clinic 3.0 (K213562) | Nobel Biocare AB | 2022-03-25 |
| BALTEUM - ONE™ Lumbar Plate System (K213820) | Huvexel Co. , Ltd. | 2022-03-25 |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System (K220242) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-25 |
| Emerge Monorail PTCA Dilatation Catheter (K220629) | Boston Scientific | 2022-03-24 |
| Steth IO Spot (K220196) | Stratoscientific | 2022-03-24 |
| X-Pac Expandable Lumbar Cage System (K220655) | Expanding Innovations, Inc. | 2022-03-24 |
| Surgical Face Mask (K202903) | Rizhao Sanqi Medical & Health Articles Co., Ltd. | 2022-03-24 |
| Disposable Medical Synthetic Nitrile Examination Gloves (K220354) | Niujian Technology Co., Ltd. | 2022-03-24 |
| Mobility Scooter, Model W3468 (K220207) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 |
| FlareHawk Interbody Fusion System (K220453) | Integrity Implants, Inc. | 2022-03-24 |
| Alio Medical Remote Monitoring System (K211365) | Graftworx, Inc. Dba Alio | 2022-03-24 |
| Dib UltraNav Transseptal Catheter System (K213492) | Dib Ultranav Medical, LLC | 2022-03-24 |
| Mobility Scooter (K220206) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 |
| Erchonia Zerona Z-Bed (K220519) | Erchonia Corporation | 2022-03-24 |
| FUBUKI XF Neurovascular Long Sheath (K213589) | Asahi Intecc Co., Ltd. | 2022-03-24 |
| AviClear Laser System (K213461) | Cutera, Inc. | 2022-03-24 |
| Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K212916) | Rimba Glove Sdn Bhd | 2022-03-24 |
| Total Immunoglobulin E (IgE) (K220178) | Beckman Coulter, Inc. | 2022-03-23 |
| DRX-Rise Mobile X-ray System (K213568) | Carestream Health | 2022-03-23 |
| Disposable Medical Surgical Mask (K212726) | Hubei Huaqiang High-Tech Co., Ltd. | 2022-03-23 |
| LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing (K210718) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-03-23 |
| PathBuilder Transseptal Needle (K212625) | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 |
| Project E Beauty LED Light Therapy Mask (Model: PE730) (K214101) | Duplex International Trading Limited | 2022-03-23 |
| ArthroFree Wireless Surgical Camera System (K213860) | Lazurite Holdings, LLC | 2022-03-23 |
| PathBuilder Transseptal Guiding Introducer (K212626) | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 |
| Pounce Thrombectomy System (K220501) | Surmodics,Inc. | 2022-03-23 |
| BD Surgiphor Antimicrobial Irrigation System (K213616) | Becton, Dickinson and Company | 2022-03-23 |
| COPAL exchange G hip spacer (K220492) | Heraeus Medical GmbH | 2022-03-23 |
| Iridex 810 Laser (K213592) | Iridex Corporation | 2022-03-23 |
| LOGIQ P10, LOGIQ P9, LOGIQ P8 (K214039) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-03-22 |
| AMSafe Pre-Filled Normal Saline Flush Syringe (K213522) | Amsino International, Inc. | 2022-03-22 |
| Medline UNITE IM Fibula Implant (K220511) | Medline Industries, LP | 2022-03-22 |
| Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 (K212960) | Canon Medical Systems Corporation | 2022-03-22 |
| Athelas Home (K200828) | Athelas, Inc. | 2022-03-22 |
| Shani Darden LED light therapy mask (K214103) | Harpar Grace International | 2022-03-22 |
| PLEXR PLUS (K210693) | Gmv S.R.L. | 2022-03-22 |
| StealthFix Intraosseous Fixation System (K220181) | Nextremity Solutions, Inc. | 2022-03-22 |
| Powder Free Blue Nitrile Examination Gloves (K213678) | Lienteh Technology Sdn Bhd | 2022-03-22 |
| Creatinine2 (K210452) | Abbott Ireland Diagnostics Division | 2022-03-22 |
| NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246) | Medtronic Xomed, Inc. | 2022-03-21 |
| WatchPAT200U (WP200U) (K203839) | Itamar Medical , Ltd. | 2022-03-21 |
| AFFINITY Proximal Tibia System (K220199) | Techfit Digital Surgery, Inc. | 2022-03-21 |
| Solus Gold Embolization Device (K213200) | Artio Medical, Inc. | 2022-03-21 |
| Multi-Functional Electrosurgical Knife (K212999) | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 |
| BriefCase (K213721) | Aidoc Medical , Ltd. | 2022-03-21 |
| Albumin BCP2 (K203530) | Abbott Ireland Diagnostics Division | 2022-03-18 |
| Stable-L Standalone Lumbar Interbody System (K212498) | Nexus Spine, LLC | 2022-03-18 |
| CELERITY 20 HP Challenge Pack (K220473) | Steris | 2022-03-18 |
| ARISTE AB Mesh (K211132) | Ariste Medical, LLC | 2022-03-18 |
| Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown (K203237) | Dukal Corporation | 2022-03-18 |
| TempSure System (K212891) | Cynosure, LLC | 2022-03-18 |
| LYMA Laser (K210823) | Lyma Life , Ltd. | 2022-03-18 |
| SURGIVISIO Device (K220627) | Ecential Robotics | 2022-03-18 |
| 15L Cycler Drainage Bag (K214016) | Baxter Healthcare Corporation | 2022-03-18 |
| F&P Evora Full Face Mask (K212371) | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 |
| Cardio Flow Peripheral Guide Wire (K213834) | Cardio Flow Inc., | 2022-03-18 |
| DePuy Synthes Radial Head Replacement System (K213563) | DePuy Synthes | 2022-03-18 |
| EMERGE Anterior Cervical Plate System (K220275) | Evolution Spine | 2022-03-18 |
| Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) (K210171) | Sichuan Youkede Medical Equipment Co.,Ltd | 2022-03-18 |
| OPTRELL Mapping Catheter with TRUEref Technology (K211438) | Biosense Webster, Inc. | 2022-03-18 |