| Cavetto-SA Cervical Cage System (K200115) | Neurostructures, Inc. | 2020-09-24 |
| Tangible Boost (DEN200002) | Tangible Science, Inc. | 2020-09-24 |
| Cordera Hip System (K202484) | Conformis, Inc. | 2020-09-24 |
| RayStation (K200569) | RaySearch Laboratories AB (PUBL) | 2020-09-24 |
| GXR-Series Diagnostic X-Ray System (K202572) | DRGEM Corporation | 2020-09-24 |
| DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (K201346) | Synthes (USA) Products, LLC | 2020-09-23 |
| Boston One Step Liquid Enzymatic Cleaner (K200416) | Bausch & Lomb, Incorporated | 2020-09-23 |
| FlareHawk TiHawk9 Interbody Fusion System (K201367) | Integrity Implants, Inc. | 2020-09-23 |
| Nerve and Muscle Stimulator (K193276) | Shenzhen Xft Medical Limited | 2020-09-23 |
| Pulse Oximeter (K200414) | Shenzhen Aeon Technology Co., Ltd. | 2020-09-23 |
| Responsive Arthroscopy Interference Screw System (K202569) | Responsive Arthroscopy, LLC | 2020-09-23 |
| Halo AF Detection System (K201208) | Livmor | 2020-09-23 |
| IBS Implant System (K202479) | Innobiosurg Co., Ltd. | 2020-09-23 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K202210) | Canon Medical Systems Corporation | 2020-09-22 |
| DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448) | Alcon Laboratories, Inc. | 2020-09-22 |
| Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs (K200843) | O&M Halyard, Inc. | 2020-09-22 |
| BD Cathena Safety IV Catheter (K201717) | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-09-22 |
| LTJ Screws and Washer (K200987) | Azurmeds, Inc. | 2020-09-22 |
| Accessories for the SixFix® Hexapod Fixator (K200123) | Arrowhead De, LLC | 2020-09-22 |
| Pounce Thrombus Retrieval System (K192814) | Surmodics,Inc. | 2020-09-21 |
| Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B (K201467) | Bioland Technology, Ltd. | 2020-09-21 |
| Medline DeNovo 4Pro Electrical Stimulation Device (K201290) | Medline Industries, Inc. | 2020-09-21 |
| World Hip Stem, World Cup, World Liner (K201278) | Signature Orthopaedics Pty, Ltd. | 2020-09-21 |
| Optiflux F180NR Dialyzer (K192707) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 |
| AAA Model (K200603) | Philips Ultrasound, Inc. | 2020-09-20 |
| CORVUS (K201350) | Best Nomos | 2020-09-20 |
| B&J DVT Calf/Thigh Garments, Models 801/830 Series (K201532) | B&J Manufacturing , Ltd. | 2020-09-19 |
| Optixon 1-Day (K201013) | Optixon, Inc. | 2020-09-18 |
| LaborView™ LV1000 Wireless Electrode System (K190798) | Obmedical Company | 2020-09-18 |
| Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) (K201390) | Medline Industires, Inc. | 2020-09-18 |
| CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (K201207) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| Seaspine WaveForm C Interbody System (K201073) | SeaSpine Orthopedics Corporation | 2020-09-18 |
| Electrosurgical Generator and Accessories (K201224) | Medrange | 2020-09-18 |
| Paragon Adult Maxi PMP Oxygenator with Tubing Pack (K201642) | Chalice Medical , Ltd. | 2020-09-18 |
| OrthoButton FL (K202399) | Riverpoint Medical | 2020-09-18 |
| EchoPAC Software Only, EchoPAC Plug-In (K200852) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-18 |
| Smart Correction System (K193368) | Wishbone Medical, Inc. | 2020-09-18 |
| Intellifuse Administration and Intellifuse Blood Administration Sets (K192375) | Smiths Medical Asd, Inc. | 2020-09-18 |
| Ran-Flex-B Bone Marrow Aspiration Needle (K202287) | Ranfac Corporation | 2020-09-18 |
| SentEP (K192890) | Sentiar, Inc. | 2020-09-18 |
| Disposable Surgical Mask (K202463) | Unisources Group, LLC | 2020-09-18 |
| DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (K192702) | Synthes (USA) Products, LLC | 2020-09-18 |
| GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) (K202022) | Medacta International S.A. | 2020-09-18 |
| Spineology Interbody Fusion System (DEN200010) | Spineology, Inc. | 2020-09-18 |
| SMS Cementless Stem (K201673) | Medacta International S.A. | 2020-09-18 |
| DIA-ROOT BIO MTA (K200174) | DiaDent Group International | 2020-09-18 |
| Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538) | Life Spine, Inc. | 2020-09-18 |
| B&J DVT Foot Garments, Models 820 Series (K201547) | B&J Manufacturing , Ltd. | 2020-09-18 |
| Caption Guidance (K201992) | Caption Health | 2020-09-18 |
| Tempus Pro Patient Monitor (K201746) | Remote Diagnostic Technologies Limited | 2020-09-18 |
| Portable Electro-Stimulation Therapy Device (K182020) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-09-17 |
| ToothWave™ (DEN190039) | Home Skinovations , Ltd. | 2020-09-17 |
| STRUXXURE®-L and STRUXXURE®-A Plate System (K202192) | Nexxt Spine, LLC | 2020-09-17 |
| ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K201494) | Advin Biotech, Inc. | 2020-09-17 |
| HemosIL Liquid Anti-Xa (DEN190032) | Instrumentation Laboratory CO | 2020-09-17 |
| Single-Use Surgical Mask With Ear Loop (K201691) | Qiqihar Hengxin Medical Supplies, Ltd. | 2020-09-17 |
| LZI Oxycodone III Enzyme Immunoassay (K202007) | Lin-Zhi International, Inc. | 2020-09-17 |
| eNAT molecular collection and preservation medium (K201849) | Copan Italia Spa | 2020-09-17 |
| GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide (K201686) | ETHICON, Inc. | 2020-09-17 |
| EUROIMMUN Anti-BP230-CF ELISA (IgG) (K193115) | Euroimmun Us, Inc. | 2020-09-17 |
| VX1 (K201298) | Volta Medical | 2020-09-16 |
| EOSedge (K202394) | Eos Imaging | 2020-09-16 |
| AVA (Augmented Vascular Analysis) (K201369) | See-Mode Technologies Pte, Ltd. | 2020-09-16 |
| Butterfly iQ Ultrasound System (K202406) | Butterfly Network, Inc. | 2020-09-16 |
| PAPAYA 3D Premium & PAPAYA 3D Premium Plus (K200469) | Genoray Co., Ltd. | 2020-09-16 |
| Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs (K201774) | Pt. Medisafe Technologies | 2020-09-16 |
| Tulsa-Pro System (K202286) | Profound Medical, Inc. | 2020-09-16 |
| Precice® Ankle Salvage System (K200430) | Nuvasive Specialized Orthopedics, Inc. | 2020-09-16 |
| Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (K201661) | Medos International SARL | 2020-09-16 |
| Ziehm Vision RFD 3D (K202360) | Ziehm Imaging GmbH | 2020-09-16 |
| ARIX Elbow System (K201656) | Jeil Medical Corporation | 2020-09-15 |
| UNIFUSE Infusion System with Cooper Wire (K202347) | AngioDynamics, Inc. | 2020-09-15 |
| Massage Compression Boots (K201645) | Jkh USA, LLC | 2020-09-15 |
| FIREBIRD SI Fusion System (K201664) | Orthofix, Inc. | 2020-09-15 |
| Athletis PTA Balloon Dilatation Catheter (K201170) | Boston Scientific Corporation | 2020-09-15 |
| Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665) | Accelerate Diagnostics, Inc. | 2020-09-15 |
| Collaboration Live (K201665) | Philips Ultrasound, Inc. | 2020-09-15 |
| AcQMap 3D Imaging and Mapping Catheter (K201341) | Acutus Medical, Inc. | 2020-09-15 |
| VIVO (K200313) | Catheter Precision, Inc. | 2020-09-14 |
| Artus™ cervical plate system (K202227) | Ulrich GmbH & Co. KG | 2020-09-14 |
| Marathon Flow Directed Micro Catheter (K202318) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 |
| VersaWrap Nerve Protector (K201631) | Alafair Biosciences, Inc. | 2020-09-14 |
| FusionFrame Ring Lock System (K200343) | Glw Medical Innovation | 2020-09-14 |
| Shoreline ACS (Anterior Cervical System) (K201646) | SeaSpine Orthopedics Corporation | 2020-09-14 |
| Feelix Stethoscope (K200862) | Sonavi Labs, Inc. | 2020-09-14 |
| Disposable Enteral Feeding Syringe with Enfit Connector (K193657) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 |
| IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 (K192137) | Philips Medizin Systeme Boeblingen GmbH | 2020-09-11 |
| AMICUS Separator System (K200530) | Fresenius Kabi AG | 2020-09-11 |
| FLEX Vessel Prep System (K202187) | Venturemed Group, Inc. | 2020-09-11 |
| PF4 Enhanced assay (K201570) | Immucor Gti Diagnostics, Inc. | 2020-09-11 |
| Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System (K201506) | Meditech Spine, LLC | 2020-09-11 |
| Porcine Mineral Collagen Composite Moldable (K201859) | Collagen Matrix, Inc. | 2020-09-11 |
| DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959) | DePuy Synthes | 2020-09-11 |
| GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System (K193340) | Microtech Medical, Inc. | 2020-09-11 |
| SABER .035 PTA Dilatation Catheter (K201333) | Cordis Corporation | 2020-09-11 |
| Aline Ablation Intelligence (K202297) | Mirada Medical, Ltd. | 2020-09-11 |
| Dynex Micro (K202143) | Vilex, LLC | 2020-09-11 |
| TK Insulin Syringe with/without Saftey Retractable Device (K191639) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-09-11 |
| Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) (K193449) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2020-09-11 |
| HotDog Temperature Management Controller (K201779) | Augustine Temperature Management | 2020-09-11 |