| Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (K202592) | Stryker | 2020-10-08 |
| ECG App (K201525) | Apple, Inc. | 2020-10-08 |
| Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (K192703) | Brainlab AG | 2020-10-08 |
| SilverStream Gel (K200767) | Enzysurge , Ltd. | 2020-10-08 |
| IPS CaseDesigner (K200810) | Nobel Biocare AB | 2020-10-08 |
| Flower Suture Anchor Set (K192949) | Flower Orthopedics Corporation | 2020-10-07 |
| Radiographic System Challenge X (K202293) | Sedecal., Sa. | 2020-10-07 |
| AcuSee AS-P1000 System (K202119) | Weipeng (Suzhou) Medical Devices Co., Ltd. | 2020-10-07 |
| ScanX Edge (K202633) | Dürr Dental SE | 2020-10-07 |
| URIS OMNI Narrow System & Prosthetic (K200817) | Truabutment, Inc. | 2020-10-07 |
| Fortilink Cages with TiPlus Technology (K201453) | Paradigm Spine GmbH | 2020-10-07 |
| Abutment Design (K200100) | 3Shape A/S | 2020-10-07 |
| Infrared Thermometer (K200802) | Shenzhen Urion Technology Co., Ltd. | 2020-10-07 |
| Livocare Surgical Mask (K201380) | Andon Health Co, Ltd. | 2020-10-07 |
| Citregen Tendon Interference Screw and Citrelock (K200725) | Acuitive Technologies | 2020-10-07 |
| NuVasive® Cohere® Thoracolumbar Interbody System (K200953) | Nu Vasive, Incorporated | 2020-10-06 |
| Pitkar DeftFix System (K200728) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-10-06 |
| R3 HA Coated Acetabular Shells (K201701) | Smith & Nephew, Inc. | 2020-10-06 |
| CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 (K202114) | Bolder Surgical, LLC | 2020-10-06 |
| TruForm Sievers Annuloplasty Ring (K202253) | Genesee Biomedical, Inc. | 2020-10-06 |
| iSleeve Introducer Set (K202584) | Boston Scientific Corporation | 2020-10-06 |
| UDE (K202292) | Ebm Technologies, Inc. | 2020-10-05 |
| KHEIRON® Spinal Fixation System (K201659) | S.M.A.I.O | 2020-10-05 |
| MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (K200792) | Medacta Inernational SA | 2020-10-05 |
| Membrane Screws and Membrane Tacks (K201561) | Neoss Limited | 2020-10-05 |
| Neonatal Phototherapy System (K200031) | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 |
| ClearEndoclip (K200217) | Finemedix Co., Ltd. | 2020-10-05 |
| Affirm Contrast Biopsy (K202294) | Hologic, Inc. | 2020-10-05 |
| Quantum Workstation 12 Elite (K202557) | Spectrum Medical , Ltd. | 2020-10-02 |
| BZF-29 (K200682) | GC America, Inc. | 2020-10-02 |
| LiverMultiScan (K202170) | Perspectum, Ltd. | 2020-10-02 |
| HAL for Medical Use(Lower Limb type) (K201559) | Cyberdyne, Inc. | 2020-10-02 |
| Materialise PKA Guide System (K202207) | Materialise NV | 2020-10-02 |
| ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device (K202218) | Boston Scientific Corporation | 2020-10-02 |
| SOZO Body Fluid Analyzer (K193410) | ImpediMed Limited | 2020-10-02 |
| Cleerly Labs v2.0 (K202280) | Cleerly, Inc. | 2020-10-02 |
| Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs (K201748) | Hartalega Sdn Bhd | 2020-10-02 |
| OssGuide (K200623) | Sk Bioland Co., Ltd. | 2020-10-02 |
| Infrared Thermometer Model E127 (K201161) | Bioland Technology, Ltd. | 2020-10-02 |
| Encore System (K201238) | Siesta Medical, Inc. | 2020-10-02 |
| X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301) | Scopio Labs , Ltd. | 2020-10-02 |
| Slow Wave DS8 (K191320) | Slow Wave, Inc. | 2020-10-02 |
| Arthrex SoftStitch (K190707) | Arthrex, Inc. | 2020-10-02 |
| Oculus-SA Lumbar Cage System (K202190) | Neurostructures | 2020-10-02 |
| OsOpia Synthetic Bone Void Filler (K201546) | Revisios BV | 2020-10-02 |
| ECG Cables and Leadwires (K201359) | Xinkang Medical Instrument Co. , Ltd. | 2020-10-01 |
| Nutricare Clear-ISOSAF Nasogastric Feeding Tube (K202357) | Three Circles Consulting Limited | 2020-10-01 |
| TELEGRAPH® EVOLUTION Humeral Nailing System (K200127) | FH Industrie | 2020-10-01 |
| Philips Avent Single/Double electric breast pump Advanced (K201381) | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-10-01 |
| SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544) | Diamond Diagnostics, Inc. | 2020-10-01 |
| Infrared PT2L Digital No-Touch Thermometer (K200710) | Andon Health Co, Ltd. | 2020-10-01 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) | Edwards Lifesiences, LLC | 2020-10-01 |
| MectaScope System (K200067) | Medacta International S.A. | 2020-10-01 |
| Wiygul Catheter (K202566) | Big Blue Biotech, Inc. | 2020-09-30 |
| Allura Vaginal Stent (K202542) | Pmt Corporation | 2020-09-30 |
| IDS-iSYS Ostase BAP (K200475) | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
| Clear Guide SCENERGY (K201188) | Clear Guide Medical | 2020-09-30 |
| e-Ortho Shoulder Software (K201928) | FH Industrie | 2020-09-30 |
| THINQ (K192051) | Corticometrics, LLC | 2020-09-30 |
| DigitalDiagnost C90 (K202564) | Philips Medical Systems Dmc GmbH | 2020-09-30 |
| EverLift Submucosal Lifting Agent (K202376) | Gi Supply, Inc. | 2020-09-30 |
| Tua Face Fitness / Tua Trend Face (K192077) | Vupiesse S.R.L | 2020-09-30 |
| Cefaly Dual (K201895) | Cefaly Technology | 2020-09-29 |
| LVivo Seamless (K202546) | Dia Imaging Analysis, Ltd. | 2020-09-29 |
| PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (K191738) | Philips Medical Systems | 2020-09-29 |
| Cadwell Apollo System (K201819) | Cadwell Industries, Inc. | 2020-09-29 |
| Dual Cure Resin Cement (K201790) | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-29 |
| BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle (K193131) | Becton, Dickinson and Company | 2020-09-29 |
| Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants (K193401) | Altatec GmbH | 2020-09-29 |
| Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) (K200557) | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 |
| VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) (K193299) | bioMerieux, Inc. | 2020-09-28 |
| Electrosurgical Generator (K201221) | New Deantronics Taiwan , Ltd. | 2020-09-28 |
| BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (K201814) | Becton, Dickinson and Company | 2020-09-28 |
| Transcend (K201795) | Ultradent Product, Inc. | 2020-09-28 |
| OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543) | Volcano Corporation | 2020-09-28 |
| da Vinci SP Surgical System (K192717) | Intuitive Surgical, Inc. | 2020-09-28 |
| RIST Radial Access Catheter (K201682) | Rist Neurovascular, Inc. | 2020-09-28 |
| Eon Aligner (K202685) | Eon Dental Jordan, LLC | 2020-09-28 |
| Portable Mesh Nebulizer (K182906) | Feellife Health, Inc. | 2020-09-27 |
| Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (K191982) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020-09-25 |
| Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent (K201756) | Stryker Sustainability Solutions | 2020-09-25 |
| Ventilator, Non-continuous (Respirator) (K201439) | Respironics, Inc. | 2020-09-25 |
| BD Preset Syringe & BD A-Line Syringe (K202446) | Becton, Dickinson and Company | 2020-09-25 |
| ImageSPECTRUM (K201273) | Canon, Inc. | 2020-09-25 |
| PUGGLE Enteral Feeding Pump and Feeding Set (K200051) | Amsino International, Inc. | 2020-09-25 |
| Xeleris V Processing and Review Systems (K201103) | GE Healthcare | 2020-09-25 |
| Distal Centralizers (K193546) | Biomet, Inc. | 2020-09-25 |
| Light Cure Dental Adhesive (K201787) | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-25 |
| Restrata® (K193583) | Acera Surgical, Inc. | 2020-09-25 |
| Synchro SELECT Guidewire (K202522) | Stryker Neurovascular | 2020-09-25 |
| Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (K202567) | Guangzhou Wondfo Biotech Co., Ltd. | 2020-09-25 |
| Honorst Implant System (K202039) | Medimecca Co., Ltd. | 2020-09-25 |
| Breezing Med (K200076) | Tf Health Co. | 2020-09-25 |
| NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (K201820) | Nu Vasive, Incorporated | 2020-09-25 |
| Surgical Face Mask (K202277) | Jiangxi 3l Medical Products Group Co., Ltd. | 2020-09-25 |
| Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (K201770) | Masimo Corporation | 2020-09-24 |
| Straumann BoneCeramic (K201051) | Institut Straumann AG | 2020-09-24 |
| EndoGI S-Path Biliary Stent System (K202477) | Endo GI Medical | 2020-09-24 |
| A-Silicone for Bite Registration (K201684) | Shandong Huge Dental Material Corporation | 2020-09-24 |
| Dermal Cooling System (K201260) | R2 Technologies, Inc. | 2020-09-24 |