| EyeStat (K191700) | Blinktbi, Inc. | 2019-12-09 |
| Southern Implants MAX Implant System (K191054) | Southern Implants (Pty), Ltd. | 2019-12-09 |
| C.T.M. Mobility Scooter HS-268 (K192885) | Chien TI Enterprise Co., Ltd. | 2019-12-09 |
| JETi Peripheral Thrombectomy System (K192439) | Walk Vascular, LLC | 2019-12-09 |
| TSV BellaTek Express and BellaTek Flex Abutments (K192522) | Biomet 3i, LLC | 2019-12-09 |
| CEDIA Benzodiazepine Assay (K190968) | Microgenics Corporation | 2019-12-09 |
| FFRangio (K192442) | Cathworks, Ltd. | 2019-12-09 |
| Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (K192225) | Vizionfocus, Inc. | 2019-12-09 |
| T3 Platform software (K190273) | Etiometry, Inc. | 2019-12-08 |
| PhantomMSK Trauma (K192279) | OrthoGrid Systems, Inc. | 2019-12-07 |
| JJ Implant System (K190552) | Jj Implants | 2019-12-06 |
| Intense Pulsed Light Treatment System (K192521) | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 |
| ALLIVE (K192773) | Nu Eyne Co., Ltd. | 2019-12-06 |
| Avenir Muller Stem, Avenir Cemented Hip Stem (K193030) | Zimmer GmbH | 2019-12-06 |
| Aurora Surgiscope System (K191861) | Rebound Therapeutics | 2019-12-06 |
| Dextile Anatomical Mesh (K192443) | Sofradim Production | 2019-12-06 |
| Smart Peak Flow Meter (K191239) | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| Intraocular Pressure Tonometer EASYTON (K190382) | Company Elamed | 2019-12-06 |
| Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (K190656) | Zimmer, Inc. | 2019-12-06 |
| Sheridan Spiral-Flex Endotracheal Tubes (K192324) | Teleflexmedical, Inc. | 2019-12-06 |
| Disposable SpO2 Sensor (K191279) | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-12-06 |
| EQUINOX Balloon Dilatation Catheter (K190612) | Dornier Medtech America, Inc. | 2019-12-06 |
| ID-Cap System (K183052) | Etectrx, Inc. | 2019-12-06 |
| 21HK512D (K191864) | Lg Electronics.Inc | 2019-12-05 |
| MCI - CMF System (K182758) | Mci Medical Concept Innovation, Inc. | 2019-12-05 |
| BC Reflex Uni Knee System (K191996) | Bodycad Laboratories, Inc. | 2019-12-05 |
| TOMi Scope (K191804) | Photonicare, Inc. | 2019-12-05 |
| Digital Intraoral Imaging Plate System (K192766) | Fsusen Technology Co., Ltd. | 2019-12-05 |
| BTL-899 (K192224) | Btl | 2019-12-05 |
| Neodent Implant System - Temporary Abutments (K191191) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-05 |
| Southern Implants PEEK Abutments (K191250) | Southern Implants (Pty), Ltd. | 2019-12-05 |
| Vitra 2 (K191962) | Quantel Medical | 2019-12-05 |
| PICO 14 Single Use Negative Pressure Wound Therapy System (K191760) | Smith & Nephew Medical Limited | 2019-12-05 |
| G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene (K190660) | Zimmer, Inc. | 2019-12-05 |
| cobas vivoDx MRSA (DEN190016) | Roche Molecular Systems, Inc. | 2019-12-05 |
| MEDRAD Mark 7 Arterion Injection System (K193028) | Bayer Medical Care, Inc. | 2019-12-05 |
| Elekta Unity (K192482) | Elekta Limited | 2019-12-05 |
| AIROS 6 Sequential Compression Device (K193069) | Airos Medical, Inc. | 2019-12-04 |
| Medline Quick Switch Valve with ENFit Connector (K191759) | Medline Industries, Inc. | 2019-12-04 |
| RELiZORB (K191379) | Alcresta Therapeutics, Inc. | 2019-12-04 |
| MolecuLight i:X (K191371) | MolecuLight, Inc. | 2019-12-04 |
| AIROS 8 Sequential Compression Device (K193068) | Airos Medical, Inc. | 2019-12-04 |
| TRACKER Kyphoplasty System (K192335) | GS Medical Co., Ltd. | 2019-12-04 |
| Epic 980 (K192430) | Biolase, Inc. | 2019-12-04 |
| SICAT Implant V2.0 (K192348) | Sicat GmbH & Co. KG | 2019-12-04 |
| VenaPro Vascular Therapy System (K193020) | Innovamed Health, LLC | 2019-12-04 |
| SeaSpine Beachside System (K192132) | SeaSpine Orthopedics Corporation | 2019-12-03 |
| Deka Tiac 1 (K183371) | El..En. Electroic Engineering Spa | 2019-12-03 |
| Promisemed Heel Blood Lancet (K193009) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-03 |
| M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System (K193083) | Medacta International S.A. | 2019-12-03 |
| CO2 Laser Therapy System (K192528) | Shangdong Huamei Technology Co., Ltd. | 2019-12-03 |
| Exsomed Wrist Plating System (K192473) | Exsomed Corporation | 2019-12-03 |
| Glidesheath Slender Tibial Pedal Kit (K193160) | Terumo Medical Coporation | 2019-12-03 |
| Straumann Modular Cassette (K191522) | Institut Straumann AG | 2019-12-03 |
| TriSalus Infusion System (K193107) | Trisalus Life Sciences | 2019-12-03 |
| Emprint Visualization Application (K192038) | Covidien, LLC | 2019-12-02 |
| Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip (K190659) | Allwin Medical Devices, Inc. | 2019-12-02 |
| Hi-Fatigue Bone Cement (K192394) | Osartis GmbH | 2019-12-02 |
| WOUNDCHEK Bacterial Status (DEN180014) | Alere Scarborough, Inc. | 2019-12-02 |
| Integra TITAN Reverse Shoulder System (K190588) | Integra LifeSciences Corporation | 2019-12-02 |
| Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (K190009) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-12-02 |
| NasalCEASE and BleedCEASE (K183622) | Les Laboratoires Brothier S.A. | 2019-12-02 |
| mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed (K190876) | Mercator Medical (Thailand), Ltd. | 2019-12-02 |
| Uroject12 Syringe Lever (K190987) | Urogen Pharma, Ltd. | 2019-12-02 |
| Vital Navigation System (K191722) | Zimmer Biomet Spine, Inc. | 2019-12-02 |
| Checkme O2 Pulse Oximeter (K191088) | Shenzhen Viatom Technology Co., Ltd. | 2019-12-02 |
| Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374) | Cardinal Health200, LLC | 2019-12-02 |
| Zipbond (K191656) | Sdi Limited | 2019-12-02 |
| Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K192666) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-02 |
| Decanting Device (K182819) | Gcmedica Enterprise Ltd.(Wuxi) | 2019-12-02 |
| Resorbable Mesh Device (K193040) | SeaSpine Orthopedics Corporation | 2019-11-30 |
| ASAHI CROSSWALK Peripheral Support Catheter (K192782) | Asahi Intecc Co., Ltd. | 2019-11-29 |
| EliA SymphonyS Immunoassay (K190710) | Phadia AB | 2019-11-29 |
| Innonix Antiviral Child's Face Mask (K192105) | Innonix Technologies Limited | 2019-11-29 |
| I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (K192186) | Neurolign USA, LLC | 2019-11-29 |
| Shoulder Innovations Total Shoulder System (K192365) | Shoulder Innovations, Inc. | 2019-11-29 |
| AXS Infinity LS Plus Long Sheath (K193034) | Stryker Neurovascular | 2019-11-29 |
| Hi-Fatigue G Bone Cement (K192379) | Osartis GmbH | 2019-11-27 |
| Multi-modality workstation (K192519) | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 |
| EOSedge (K192079) | Eos Imaging | 2019-11-27 |
| Rhythmia HDxTM Mapping System (K192438) | Boston Scientific Corporation | 2019-11-27 |
| Orapeutic (K191987) | Forward Science | 2019-11-27 |
| Upper Arm Blood Pressure Monitor (K191673) | Famidoc Technology Company Limited | 2019-11-27 |
| Optimus NEURO System - Sterile Kit (K190811) | Osteonic Co., Ltd. | 2019-11-27 |
| Hypotension Decision Assist (K190955) | Directed Systems, Ltd. | 2019-11-27 |
| Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter (K192468) | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 |
| World Knee Total Knee Systems (K190577) | Signature Orthopaedics Pty, Ltd. | 2019-11-27 |
| 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (K192945) | 7D Surgical, Inc. | 2019-11-27 |
| fMRI Hardware System (K191032) | Nordicneurolab AS | 2019-11-27 |
| Diagnostic Ultrasound System (K192791) | Edan Instruments, Inc. | 2019-11-27 |
| 3Shape Splint Design (K191911) | 3Shape A/S | 2019-11-27 |
| ECG Cable (K191428) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-11-27 |
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |
| DePuy Synthes Trauma Screws (K192745) | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-11-26 |
| NeuroOne Cortical Electrode (K192764) | Neuroone, Inc. | 2019-11-26 |
| HealthCXR (K192320) | Zebra Medical Vision, Ltd. | 2019-11-26 |
| Peridot Intervertebral body fusion System (K192026) | Gbs Commonwealth Co., Ltd. | 2019-11-26 |
| Advocate PTA Catheter (K192907) | Merit Medical Systems, Inc. | 2019-11-26 |
| TRAUS Dental Handpieces (K182892) | Saeshin Precision Co., Ltd. | 2019-11-26 |
| Streamline MIS Spinal Fixation System (K192396) | Pioneer Surgical Technology, Inc. | 2019-11-26 |