| IonicRF Generator (K201610) | ABBOTT MEDICAL | 2020-10-21 |
| EVA15 (K202799) | Palliare , Ltd. | 2020-10-21 |
| C4 Fiducial Marker (K192771) | C4 Imaging, LLC | 2020-10-21 |
| PleurX Peritoneal Catheter System (K201155) | Care Fusion | 2020-10-21 |
| Iridex 810 Laser (K202760) | Iridex Corporation | 2020-10-21 |
| Powerpress Recovery Unit (K202044) | Hanuri Distribution, Inc. | 2020-10-21 |
| OASIS MRI System (K202030) | Hitachi Healthcare Americas | 2020-10-21 |
| Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268) | Plexus Optix, Inc. | 2020-10-21 |
| Vial2Bag Advanced 20mm Admixture Device (K201415) | West Pharmaceutical Services Az, Inc. | 2020-10-21 |
| ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (K201438) | Arlington Scientific, Inc. (Asi) | 2020-10-21 |
| InnovaMatrix (K193552) | Triad Life Sciences, Inc. | 2020-10-21 |
| S.I.N. Instrument Kits (K201688) | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-10-21 |
| YSIO X.pree (K201670) | Siemens Medical Solutions USA, Inc. | 2020-10-21 |
| Pentacam AXL Wave (K201724) | Oculus Optikgerate GmbH | 2020-10-21 |
| ACTIS Duofix Hip Prosthesis (K202472) | DePuy Orthopaedics, Inc. | 2020-10-21 |
| Trivergent Spinal Fixation System (K201427) | Benvenue Medical, Inc. | 2020-10-21 |
| SpineJack Expansion Kit (K202393) | Stryker Corporation | 2020-10-20 |
| MS Lide Implant Systems (K181477) | Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. | 2020-10-20 |
| Hexanium® ACIF (K193000) | Spinevision, S.A.S. | 2020-10-20 |
| AccelFix Spinal Fixation System (K200794) | L&K BIOMED Co., Ltd. | 2020-10-20 |
| Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (K202756) | CooperVision, Inc. | 2020-10-20 |
| WEGO-PDO Barbed Suture (K201139) | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 |
| 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ (K202374) | Shenzhen Beacon Display Technology Co., Ltd. | 2020-10-19 |
| anti-bacterial bandage (K200821) | Planet (Suzhou) Medical Products Co., Ltd. | 2020-10-19 |
| Zavation IBF System (K200084) | Zavation Medical Products, LLC | 2020-10-19 |
| Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100) | Neocis, Inc. | 2020-10-19 |
| TAPESTRY Biointegrative Implant (K201572) | Embody, Inc. | 2020-10-19 |
| Transcutaneous Electronic Nerve Stimulator (K200237) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020-10-19 |
| Single Use Rotatable and Repositionable Hemoclip (K201771) | Anrei Medical (Hangzhou) Co., Ltd. | 2020-10-19 |
| CD Horizon Spinal System (K202771) | Medtronic | 2020-10-19 |
| VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (K200408) | Shenzhen Vitavitro Biotech Co., Ltd. | 2020-10-16 |
| MINICONE Implant (K200906) | Medentika GmbH | 2020-10-16 |
| Disposable Vinyl Glove (K202010) | Better Health Medical Products Co., Ltd. | 2020-10-16 |
| A View LCS (K201710) | Coreline Soft Co., Ltd. | 2020-10-16 |
| Selectra 3D Outer Guiding Catheters (K193474) | Biotronik, Inc. | 2020-10-16 |
| Medline Smoke Evacuation Pencil (K201129) | Medline Industires, Inc. | 2020-10-16 |
| ARTHROTAP (K201816) | Accuro Technologies, Inc. | 2020-10-16 |
| Finetest Lite Smart Blood Glucose Monitoring System (K201396) | Osang Healthcare Co. , Ltd. | 2020-10-16 |
| MUTARS Cemented Femoral Stems (K200045) | Implantcast GmbH | 2020-10-16 |
| Quantum Ventilation Module (K202733) | Spectrum Medical , Ltd. | 2020-10-16 |
| OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K201803) | OSSIO , Ltd. | 2020-10-16 |
| Dall-Miles® Cable System (K202016) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 |
| Cerament Bone Void Filler (K201535) | Bonesupport AB | 2020-10-16 |
| PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction (K202193) | S.B.M. Sas (Science & Bio Materials) | 2020-10-16 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System (K202737) | Canon Medical Systems Corporation | 2020-10-16 |
| CellaVision DC-1, CellaVision DC-1 PPA (K200595) | CellaVision AB | 2020-10-16 |
| Foley Catheter with Temperature Sensor (K200757) | Deroyal Industries, Inc. | 2020-10-15 |
| Opera Evo (K202041) | Quanta System Spa | 2020-10-15 |
| SIGNA 7.0T (K201615) | Ge Medical Systems, LLC | 2020-10-15 |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System (K202683) | Siemens Medical Solutions USA, Inc. | 2020-10-15 |
| Arthrosurface WristMotion Total Wrist Arthroplasty System (K200718) | Arthrosurface, Inc. | 2020-10-15 |
| Invictus™ OsseoScrew® System (K202327) | Alphatec Spine, Inc. | 2020-10-15 |
| LIAISON Testosterone xt (K201908) | DiaSorin, Inc. | 2020-10-15 |
| Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm (K202665) | Ethicon Endo-Surgery, LLC | 2020-10-15 |
| icotec Anterior Cervical Plate System (K201587) | Icotec AG | 2020-10-15 |
| SINUSPRIME Dilation System (K201398) | Stryker Ent | 2020-10-15 |
| xPORT S Lens Fragmentation System (K200207) | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-10-15 |
| Cartesion Prime, PCD-1000A, V10.7 (K202349) | Canon Medical Systems Corporation | 2020-10-15 |
| OsteoMed ExtremiFix Mini & Small Cannulated Screw System (K202680) | Osteomed, LLC | 2020-10-15 |
| Droplet Pen Needle 30G & 33G (K202340) | Htl-Strefa S.A | 2020-10-15 |
| STATSTIX (K200764) | Centrix Incorporated | 2020-10-15 |
| Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (K200296) | Pegavision Corporation | 2020-10-15 |
| Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 (K202364) | Canon Medical Systems Corporation | 2020-10-15 |
| Merit Hydrophilic Guide Wire (K201595) | Merit Medical Systems, Inc. | 2020-10-14 |
| Z5-BL (K200386) | Z-Systems AG | 2020-10-14 |
| CONSTRUX Mini PTC Spacer System (K202666) | Orthofix, Inc. | 2020-10-14 |
| Spirotrac (K201562) | Vitalograph Ireland, Ltd. | 2020-10-14 |
| Astroglide Organix Liquid (K200114) | Biofilm, Inc. | 2020-10-13 |
| G21 Cement, VADER® Pedicle System (K200596) | Icotec AG | 2020-10-13 |
| Skeletal Dynamics Ulnar Shortening Plating System (K201962) | Skeletal Dynamics, Inc. | 2020-10-13 |
| Zavation IBF System (K202305) | Zavation Medical Products, LLC | 2020-10-13 |
| Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633) | 0 & M Halyard, Inc. | 2020-10-11 |
| syngo.CT Neuro Perfusion (K202213) | Siemens Medical Solutions USA, Inc. | 2020-10-11 |
| Yushan X-Ray Flat Panel Detector with DROC (K201528) | Innocare Optoelectronics Corp. | 2020-10-11 |
| Quantib Prostate (K202501) | Quantib B.V. | 2020-10-11 |
| Voluson SWIFT, Voluson SWIFT+ (K201828) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-10-11 |
| Medline ENfit OTC Feeding Syringe (K202285) | Medline Industries, Inc. | 2020-10-09 |
| Klassic Knee System Tibial Inserts, PS-Max (K202740) | Total Joint Orthopedics, Inc. | 2020-10-09 |
| BIOTEQ Drainage Catheter Set (One Step Type) (K200103) | Bioteque Corporation | 2020-10-09 |
| Stethee Pro 1, Stethee Pro Software System (K193631) | M3Dicine Pty , Ltd. | 2020-10-09 |
| SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter (K201377) | Cordis Corporation | 2020-10-09 |
| BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (K201983) | Med-El Elektromedizinische Geraete GmbH | 2020-10-09 |
| Zeos Aqua Vision Pump and tube (K192921) | Hemodia Sas | 2020-10-09 |
| Instrument Clamps Electromagnetic (K202609) | Stryker Corporation | 2020-10-09 |
| Multi-LinkTM X2 ECG Adapter and Leadwires (K200510) | Vyaire Medical, Inc. | 2020-10-09 |
| Luce Ceramic Bracket (K201038) | Luce Castle Co., Ltd. | 2020-10-09 |
| V20, V20a, AVSM3 SNF (K200434) | Mediana Co., Ltd. | 2020-10-09 |
| AEON Endoscopic Stapler (K201882) | Lexington Medical, Inc. | 2020-10-09 |
| GAIA Lumbar Interbody Fusion Device (LIFD) Family (K201939) | Printerprezz | 2020-10-08 |
| Steripath Micro Blood Collection System (K200661) | Magnolia Medical Technologies, Inc. | 2020-10-08 |
| LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K200793) | L&K BIOMED Co., Ltd. | 2020-10-08 |
| Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) (K201845) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-10-08 |
| 31HN713D (K201777) | Lg Electronics.Inc | 2020-10-08 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (K201972) | Canon Medical Systems Corporation | 2020-10-08 |
| Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478) | Boston Scientific Corporation | 2020-10-08 |
| Piccolo Composite Proximal Tibia Plate System (K201917) | CarboFix Orthopedics , Ltd. | 2020-10-08 |
| Schoelly Cystoscopes/Hysteroscopes and Accessories (K201970) | Schoelly Fiberoptic GmbH | 2020-10-08 |
| Impression Material (K201483) | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020-10-08 |
| Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 (K193542) | Bellco Srl | 2020-10-08 |
| Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (K202309) | Zimmer Biomet Spine, Inc. | 2020-10-08 |