| XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (K193319) | Vasoptic Medical, Inc. | 2020-06-01 |
| ProCell Surgical Sponge-Blood Recovery Unit (K193361) | Procell Surgical, Inc. | 2020-06-01 |
| Jimushi Sterile Urethral Catheter for single use (K200134) | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 |
| 3MTM AttestTM Rapid 5 Steam-Plus Test Pack (K200536) | 3M Complany | 2020-06-01 |
| BRAINSTREAM Disposable Deep Cup EEG Electrodes (K200540) | Conmed Corporation | 2020-06-01 |
| SleepRight ProRx Custom Dental Guard (K193577) | Splintek, Inc. | 2020-06-01 |
| Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (K193077) | Covidien | 2020-06-01 |
| UNI*FUSE Infusion System with Cooper Wire (K192864) | AngioDynamics, Inc. | 2020-06-01 |
| uWS-MR (K192601) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-01 |
| Idys ALIF ZP 3DTi (K200920) | Clariance, Sas | 2020-05-29 |
| Dental Zirconia Blocks (K192262) | De Corematrix Co., Ltd. | 2020-05-29 |
| LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602) | Lv Liberty Vision Corporation | 2020-05-29 |
| iLab Polaris Multi-Modality Guidance System (K201178) | Boston Scientific | 2020-05-29 |
| Stealthstation S8 Spine Software v1.3.0 (K201189) | Medtronic Navigation, Inc. | 2020-05-29 |
| ROSA ONE Brain application (K200511) | Medtech S.A | 2020-05-29 |
| KONG-TL VBR System, KONG-C VBR System (K200235) | Icotec AG | 2020-05-29 |
| Aspire Mechanical Aspirator G (K200629) | Control Medical Technology | 2020-05-29 |
| XO Score Percutaneous Transluminal Angioplasty Scoring Catheter (K193495) | Transit Scientific | 2020-05-29 |
| Automatic Digital Blood Pressure Monitor (K190982) | Xiamen Ants Bro Technology Co., Ltd. | 2020-05-29 |
| CFP-3131, CFP-2222 (K201172) | Mx Imaging, Inc. | 2020-05-29 |
| Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) | 4Web, Inc. | 2020-05-29 |
| Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 (K191334) | Matia Robotics (Us), Inc. | 2020-05-29 |
| ADVIA Centaur Vitamin D Total (VitD) (K200509) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 |
| Crownjun Nylon Suture (K192420) | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| REVOLVE ENVI 600 Advanced Adipose System (K193539) | Lifecell Corporation | 2020-05-28 |
| DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System (K200979) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-28 |
| Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 (K192981) | Penumbra, Inc. | 2020-05-28 |
| firefly T-2 (K201131) | Firstkind Limited | 2020-05-28 |
| Meridian Anterior Plate System, Regatta Lateral Plate System (K200885) | SeaSpine Orthopedics Corporation | 2020-05-28 |
| PicoSecond Nd: YAG Laser System (K200116) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-28 |
| Brainomix 360 e-CTA (K192692) | Brainomix Limited | 2020-05-28 |
| Frozen N (K193665) | Yozma Bmtech Co., Ltd. | 2020-05-28 |
| Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (K193336) | Synedgen, Inc. | 2020-05-27 |
| Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector (K200253) | Ethicon Endo-Surgery | 2020-05-27 |
| Stimuplex Onvision System (K192914) | Philips Medical Systems Nederland B.V. | 2020-05-27 |
| AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112) | Arrow International, Inc. | 2020-05-27 |
| Guardian Needle Electrode (K200984) | Rhythmlink International, LLC | 2020-05-27 |
| Joline Kyphoplasty System Allevo (K192449) | Joline GmbH & Co. KG | 2020-05-27 |
| Restoration® Modular Hip System (K193233) | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2020-05-27 |
| TRV (K192652) | Interacoustics A/S | 2020-05-27 |
| Medical Diode Laser Hair Removal System (K200525) | Weifang Mingliang Electronics Co., Ltd. | 2020-05-27 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K201120) | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-05-27 |
| Phacoemulsification Needle (Tip) and Irrigation Sleeve (K192418) | Raico, LLC | 2020-05-27 |
| NPseal (K200305) | Guard Medical, Inc. | 2020-05-26 |
| Aqua Naina Sterile Saline Solution (K193441) | Chemtex USA, Inc. | 2020-05-26 |
| Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118) | Medtronic, Inc. | 2020-05-26 |
| The iNAP One Sleep Therapy System (K193460) | Somnice, Inc. | 2020-05-26 |
| Maximus System (K200988) | Hill-Rom Services Pte, Ltd. | 2020-05-26 |
| ReWalk P6.0 (K200032) | Re Walk Robotics , Ltd. | 2020-05-26 |
| High-speed air turbine handpiece / Low-speed air turbine handpiece (K181691) | Foshan Wenjian Medical Instrument Co., Ltd. | 2020-05-26 |
| GentleMax Pro Plus (K201111) | Candela Corporation | 2020-05-26 |
| UNIEXPERT 2 PLUS (K200944) | Adani | 2020-05-26 |
| DiaPlus (K192392) | DiaDent Group International | 2020-05-26 |
| ACUSON Juniper Diagnostic Ultrasound System (K201130) | Siemens Medical Solutions USA, Inc. | 2020-05-26 |
| Surgical Gown (K192560) | Shandong Kangli Medical Equipment Technology Co., Ltd. | 2020-05-22 |
| VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K193423) | Icotec AG | 2020-05-22 |
| VERIFY Assert Self-Contained Biological Indicator (K200126) | STERIS Corporation | 2020-05-22 |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (DEN190037) | Anx Robotica, Inc. | 2020-05-22 |
| Invictus™ CT Spinal Fixation System (K200936) | Alphatec Spine, Inc. | 2020-05-22 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) | Philips Image Guided Therapy Corporation | 2020-05-22 |
| SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (K190559) | AngioDynamics, Inc. | 2020-05-22 |
| JPS JuniOrtho Plating System (K200246) | Orthofix Srl | 2020-05-22 |
| Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming (K200457) | CC Wellness, LLC | 2020-05-22 |
| Kalera Vacuum Aspiration Catheter (K-VAC) (K200419) | Kalera Medical, Inc. | 2020-05-22 |
| Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps (K191847) | Adeor Medical AG | 2020-05-22 |
| CO2 Sidestream Module (K192488) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 |
| V30 system, V20 system, V10 system, V-FC Handpiece (K200468) | Viora , Ltd. | 2020-05-21 |
| CO2 Mainstream Module (K192446) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 |
| Systane iLux2 (K200400) | Tear Film Innovations, Inc. | 2020-05-21 |
| CariCloud (K200274) | Caristo Diagnostics | 2020-05-21 |
| Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface (K201068) | Medtronic, Inc. | 2020-05-21 |
| SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (K200483) | Boston Scientific Corporation | 2020-05-21 |
| Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) (K192342) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 |
| Advincula Delineator Uterine Manipulator (K201086) | CooperSurgical, Inc. | 2020-05-21 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K200737) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-05-21 |
| LotusCatheter (Lotus No Balloon Catheter) (K191512) | Hakki Medical Technologies, Inc. | 2020-05-21 |
| IntraMarX 3D Radiopaque Marker (K201106) | Anx Robotica Corp | 2020-05-21 |
| NEXXT MATRIXX System (K200969) | Nexxt Spine, LLC | 2020-05-21 |
| Photodynamic Therapy (PDT) Equipment (K200751) | Shangdong Huamei Technology Co., Ltd. | 2020-05-21 |
| Getinge Assured MI Steam Migrating Integrator (K200252) | Steritec Products Mfg Co, Inc. | 2020-05-21 |
| Insignia™ Anterior Cervical Plate System (K200995) | Alphatec Spine, Inc. | 2020-05-21 |
| Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (K192879) | Edan Instruments, Inc. | 2020-05-21 |
| X-Guide® Surgical Navigation System (K200662) | X-Nav Technologies, LLC | 2020-05-21 |
| BeneVision Central Monitoring System (K193391) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 |
| NuVasive Thoracolumbar Plates (K200956) | Nu Vasive, Incorporated | 2020-05-21 |
| gi-4000 Electrosurgical Generator (K192265) | United States Endoscopy Group, Inc. | 2020-05-21 |
| LifeFlow Blood System (K191362) | 410 Medical, Inc. | 2020-05-20 |
| Axis Spine Technologies ALIF (K200352) | Axis Spine Technologies, Ltd. | 2020-05-20 |
| HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (K200860) | M.I.Tech Co., Ltd. | 2020-05-20 |
| K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (K192727) | Kamiya Biomedical Company | 2020-05-20 |
| Infinity Angioplasty Balloon Catheter (K192399) | Infinity Angioplasty Balloon Company, LLC | 2020-05-20 |
| NuVasive® ACP System (K201078) | Nu Vasive, Incorporated | 2020-05-20 |
| Reform Pedicle Screw System (K200303) | Precision Spine | 2020-05-19 |
| TOPAZ Mobile DR System (K201124) | DRGEM Corporation | 2020-05-19 |
| CUBEScan BioCon-900S (K200749) | Mcube Technology Co., Ltd. | 2020-05-19 |
| SMOOV O10 (K192016) | Alber GmbH | 2020-05-19 |
| 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (K200864) | Shenzhen Beacon Display Technology Co., Ltd. | 2020-05-19 |
| MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF (K191906) | MiRus, LLC | 2020-05-18 |
| Natus NeuroWorks (K200878) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 |
| Catalys Precision Laser System (K200056) | Amo Manufacturng USA, LLC | 2020-05-18 |