| T3 Platform software (K202306) | Etiometry, Inc. | 2020-11-25 |
| Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (K193155) | Nipro Renal Solutions USA, Corp. | 2020-11-25 |
| Dermatological Carbon Dioxide Laser Systems (K202250) | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | 2020-11-25 |
| SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (K201193) | SeaSpine Orthopedics Corporation | 2020-11-25 |
| The Multimodality Advanced Vessel Analysis (K203216) | Philips Medical Systems Nederland B.V. | 2020-11-25 |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K202194) | Depuy Ireland UC | 2020-11-25 |
| Night Guard (K202465) | 3D Diagnostix, Inc. | 2020-11-25 |
| CARTO® 3 EP Navigation System with Signal Processing Unit (K200484) | Biosense Webster, Inc. | 2020-11-25 |
| Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (K202470) | Everyway Medical Instruments Co.,Ltd | 2020-11-25 |
| DR-HO'S Electro Therapy Conductive Gel (K200402) | Guangzhou Xinbo Electronic Co., Ltd. | 2020-11-25 |
| Tenax Laser Resistant Endotracheal Tube (K200761) | Bryan Medical, Inc. | 2020-11-25 |
| Anterior Cervical Plate System (K202972) | Nutech Spine and Biologics | 2020-11-24 |
| RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (K203120) | Lsi Solutions, Inc. | 2020-11-24 |
| C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K203024) | Pentax of America, Inc. | 2020-11-24 |
| Monet Curing Laser (K201904) | CAO Group, Inc. | 2020-11-24 |
| Promisemed Triple Safety Pen Needle (K202682) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-11-24 |
| ACENT™ Central Venous Catheter (K193158) | Global Medikit Limited | 2020-11-24 |
| G-CEM ONE (K200798) | GC America, Inc. | 2020-11-24 |
| CADScor System (DEN190047) | Acarix A/S | 2020-11-24 |
| Medical surgical mask (K201622) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-24 |
| NUVO Implant System – NUVO Instrument Kit Cases (K202515) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-11-24 |
| RF Surgical Generator (K200931) | Fulwell, LLC | 2020-11-24 |
| PolyLock Plating System (K202959) | Fusion Orthopedics, LLC | 2020-11-24 |
| RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (K203081) | Lsi Solutions | 2020-11-24 |
| eKuore One Wireless Electronic Interface for stethoscope (K201742) | Chip Ideas Electronics S.L. | 2020-11-24 |
| OptoMonitor 3 (K202943) | Opsens, Inc. | 2020-11-24 |
| Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) (K193621) | Dongguan E-Test Technology Co., Ltd. | 2020-11-23 |
| Somnos Anti-Snoring Mouth Guard (K201484) | Koncept Innovators, LLC | 2020-11-23 |
| PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (K202475) | Heraeus Medical GmbH | 2020-11-23 |
| Invictus™ Spinal Fixation System (K203056) | Alphatec Spine, Inc. | 2020-11-23 |
| Mirus Ligating Clip, Mirus Ligating Clip Applier (K200166) | M/s. Meril Endo Surgery Private Limited. | 2020-11-23 |
| Confirm Rx Insertable Cardiac Monitor (K202888) | Abbott (St. Jude Medical) | 2020-11-23 |
| Medical surgical mask (K201991) | Shenzhen Everwin Precision Technology Co., Ltd. | 2020-11-23 |
| Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (K202090) | Molnlycke Health Care Us, LLC | 2020-11-22 |
| MiniCAT 2D (K201825) | Xoran Technologies, LLC | 2020-11-20 |
| Optimized Positioning System (OPS) Insight (K202805) | Corin USA | 2020-11-20 |
| NeuroStar Advanced Therapy (K201158) | Neuronetics, Inc. | 2020-11-20 |
| V-ONESTEP (K193285) | Vitromed GmbH | 2020-11-20 |
| FilmArray Global Fever Panel (DEN200043) | Biofire Defense, LLC | 2020-11-20 |
| Codman Surgical Patties & Strips (K193346) | Integra LifeSciences Corporation | 2020-11-20 |
| Silatrix Oral Gel (K202000) | Sa3, LLC | 2020-11-20 |
| TIPCAM1 Rubina Video Endoscope System (K201526) | Karl Storz Endoscopy America | 2020-11-20 |
| Dornier MAGELLAN Ureteral Access Sheath (K201815) | Dornier Medtech America, Inc. | 2020-11-20 |
| CorInsights MRI (K193287) | Adm Diagnostics, Inc. | 2020-11-20 |
| Ortho Solutions Plating System (K202764) | Ortho Solutions UK , Ltd. | 2020-11-20 |
| Medical surgical mask (K202139) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-20 |
| Revolution Ascend (K203169) | Ge Healthcare Japan Corporation | 2020-11-20 |
| ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring (K202529) | Prosomnus Sleep Technologies, Inc. | 2020-11-20 |
| Vscan Air (K202035) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 |
| Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft (K202962) | New Deantronics Taiwan , Ltd. | 2020-11-20 |
| Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K202042) | Innovative Health, LLC | 2020-11-20 |
| Arthrex Eclipse Titanium Humeral Head (K203100) | Arthrex, Inc. | 2020-11-20 |
| LC ResinCal PC (K202413) | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 |
| Optomed Smartscope M5 with Optomed Smartscope FA (K201325) | Optomed Oyj | 2020-11-20 |
| Passio Pump Drainage System (K201404) | Bearpac Medical | 2020-11-20 |
| Puritan Bennett 980 Series Ventilator System (K193056) | Covidien, LLC | 2020-11-20 |
| FilmArray Global Fever Panel External Control Kit (K202382) | Biofire Defense, LLC | 2020-11-20 |
| MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191) | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| Fortress Introducer Sheath System (K203179) | Contract Medical International, GmbH | 2020-11-20 |
| HALO (K200873) | Nico-Lab B.V. | 2020-11-20 |
| MPS 3 ND Myocardial Protection System (K201984) | Quest Medical, Inc. | 2020-11-20 |
| Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (K193576) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-11-20 |
| DTX Studio Clinic (K203156) | Nobel Biocare AB | 2020-11-20 |
| SMR TT Augmented Glenoid System (K200171) | Lima Corporate S.P.A. | 2020-11-19 |
| FotoDent denture (K200580) | Dreve Dentamid GmbH | 2020-11-19 |
| Carewear Firefly Wrinkle Reduction (K202442) | Carewear Corp. | 2020-11-19 |
| Air Compression Therapy Device (K201694) | Shenzhen Dongjilian Electronics Co., Ltd. | 2020-11-19 |
| GM501 Wash with Phenol Red and Gentamicin (K192503) | Hamilton Thorne Incorporated | 2020-11-19 |
| Laser Therapy Device (K202980) | Shenzhen Leaflife Technology Co., Ltd. | 2020-11-19 |
| DePuy Corail AMT Hip Prosthesis (K203167) | DePuy Orthopaedics, Inc. | 2020-11-19 |
| K2 MOBILE (K200693) | Hulaser, Inc. | 2020-11-19 |
| StarWalker (K202172) | Fotona D.O.O. | 2020-11-19 |
| DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K203008) | Cardiovascular Systems, Inc. | 2020-11-19 |
| Sapphire Infusion Pump, Sapphire administration sets (K192860) | Q Core Medical , Ltd. | 2020-11-19 |
| Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867) | Baxter Healthcare Corporation | 2020-11-19 |
| Liebel-Flarsheim IBP Transfer Set (K193010) | Liebel-Flarsheim Company, LLC | 2020-11-18 |
| DBSWIN, VISTAEASY (K203287) | Dürr Dental SE | 2020-11-18 |
| GlidePath 7.5F Long-Term Dialysis Catheter (K202150) | C.R. Bard, Inc. | 2020-11-18 |
| Chrome (K202503) | Quanta System Spa | 2020-11-18 |
| Freedom(R) - TiNbN Coated Knee (K200912) | Maxx Orthopedics, Inc. | 2020-11-18 |
| Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein (K202449) | Medline Industries, Inc. | 2020-11-18 |
| syngo.via MI Workflows, syngo MBF (K201195) | Siemens Medical Solutions USA, Inc. | 2020-11-18 |
| HiRise (K203187) | Curvebeam, LLC | 2020-11-18 |
| Viveve System (K200472) | Viveve Medical, Inc. | 2020-11-18 |
| Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K202821) | Penumbra, Inc. | 2020-11-18 |
| Pacific Plus PTA Catheter (K202800) | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020-11-18 |
| Venue Go (K202233) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-18 |
| X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (K201382) | De Gotzen S.R.L. | 2020-11-18 |
| FIREBIRD SI Fusion System (K203138) | Orthofix, Inc. | 2020-11-18 |
| TrueView 100 Pro (K202713) | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 |
| Genius AI Detection (K201019) | Hologic, Inc. | 2020-11-18 |
| Arthrex FastThread Interference Screw (K202535) | Arthrex, Inc. | 2020-11-18 |
| Disposable Trocar (K202931) | Wuxi Shukang Medical Appliance Co., Ltd. | 2020-11-17 |
| R501 aortic root cannula without vent line, R502 aortic root cannula with vent line (K200612) | Sorin Group Italia S.R.L. | 2020-11-17 |
| Knotless TensionTight Button Implant System (K202444) | Arthrex, Inc. | 2020-11-17 |
| Activ Fuse (K202307) | Newclip Technics | 2020-11-17 |
| VeriFixx™ Small Bone Implant (K202777) | Armis Biopharma, Inc. | 2020-11-17 |
| JETi AIO Peripheral Thrombectomy System (K201998) | Walk Vascular, LLC | 2020-11-17 |
| S.I.N. Dental Implant System (K200992) | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-11-17 |
| PROView (K193306) | GE Medical Systems SCS | 2020-11-17 |