| Advisor VL Circular Mapping Catheter, Sensor Enabled (K192037) | ABBOTT MEDICAL | 2019-09-17 |
| Discovery Pico, Discovery Pico Plus, Discovery Pico Derm (K191842) | Quanta System Spa | 2019-09-17 |
| Sim&Size (K190049) | Sim&Cure | 2019-09-17 |
| Reusable NIBP Cuff (K191253) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-09-17 |
| AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (K191641) | Industrias Medicas Sampedro S.A.S | 2019-09-16 |
| Full Automatic (NIBP) Blood Pressure Monitor (K190507) | Health & Life Co., Ltd. | 2019-09-16 |
| Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim (K191800) | Kossan International Sdn Bhd | 2019-09-16 |
| AccelFix Lumbar Interbody Fusion Cage System (K190708) | L&K BIOMED Co., Ltd. | 2019-09-16 |
| PicoWay Laser System (K191685) | Candela Corporation | 2019-09-16 |
| SubtleMR (K191688) | Subtle Medical, Inc. | 2019-09-16 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K191676) | Vioptix, Inc. | 2019-09-16 |
| Mercury® Spinal System, Overwatch® Spinal System (K191576) | Spinal Elements, Inc. | 2019-09-16 |
| 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe (K191378) | Medline Industries, Inc. | 2019-09-15 |
| TDM Screw Systems (K190830) | Tdm Co., Ltd. | 2019-09-13 |
| CapMedic (K183586) | Cognita Labs, LLC | 2019-09-13 |
| Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens (K183670) | Visco Vision, Inc. | 2019-09-13 |
| Infinix Universal Composite (K182921) | Nobio , Ltd. | 2019-09-13 |
| Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (K191021) | Terragene S.A. | 2019-09-13 |
| SCENARIA View (K190841) | Hitachi Healthcare Americas | 2019-09-13 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| JuggerStitch Meniscal Repair Device (K191459) | Biomet, Inc. | 2019-09-13 |
| PROBEAT-CR (K191801) | Hitachi , Ltd. | 2019-09-13 |
| Bellavista (K183364) | Imtmedical AG | 2019-09-13 |
| NICO Myriad NOVUS (K191599) | Nico Corporation | 2019-09-13 |
| Roosin Xeroform Petrolatum Dressing (K181478) | Roosin Medical Co., Ltd. | 2019-09-13 |
| ARCHITECT STAT High Sensitivity Troponin-I (K191595) | Abbott Laboratories Diagnostics Division | 2019-09-13 |
| NCB Plating System Distal Femur and Proximal Tibia (K192217) | Zimmer GmbH | 2019-09-13 |
| ACIST RXi System and Navvus II Catheter (K190473) | Acist Medical Systems, Inc. | 2019-09-13 |
| RFID Localization System (K190932) | Health Beacons, Inc. | 2019-09-13 |
| Arthrex Tenodesis Button (K190288) | Arthrex, Inc. | 2019-09-13 |
| Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (K190005) | Sterilucent, Inc. | 2019-09-13 |
| SIS Software Version 3.6.0 (K192304) | Surgical Information Sciences, Inc. | 2019-09-13 |
| Multi-Link X2 ECG and SpO2 Adapter (K191273) | Vyaire Medical, Inc. | 2019-09-13 |
| Pulse Oximeter (K190869) | Shenzhen Aeon Technology Co., Ltd. | 2019-09-13 |
| Capillus 112, Capillus 244 (K192012) | Capillus | 2019-09-12 |
| CO2 Laser System (K191518) | Shenzhen Gsd Tech Co., Ltd. | 2019-09-12 |
| OrthoAnalysis Software (K183695) | Inteware Co., Ltd. | 2019-09-12 |
| Republic Spine Restore Intervertebral Body Fusion System (K190398) | Republic Spine, LLC | 2019-09-12 |
| syngo Application Software (K190780) | Siemens Medical Solution USA, Inc. | 2019-09-12 |
| Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (K190002) | Shanghai Kohope Medical Devices Co., Ltd. | 2019-09-12 |
| Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (K191148) | Medtronic Sofamor Danek USA, Inc. | 2019-09-12 |
| mont blanc & mont blanc MIS Spinal Systems (K191726) | Spineway SA | 2019-09-12 |
| Saline Wound Wash, SteriCleanse(TM) (K183662) | Ascent Consumer Products, Inc. | 2019-09-12 |
| faceLITE (K191629) | Ismart Marketing Svcs, Ltd. | 2019-09-12 |
| uDR 592h, uDR 596i (K192293) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-09-12 |
| Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (K191419) | Rex Medical, L.P. | 2019-09-12 |
| ARTIS icono (K190768) | Siemens Medical Solutions USA, Inc. | 2019-09-12 |
| CRC PC Smart Chamber K1 (K192199) | Capintec, Inc. | 2019-09-12 |
| Ali Interbody Fusion System (K191516) | Raed M. Ali, M.D., Inc. | 2019-09-12 |
| MectaLock Ti Suture Anchor (K191300) | Medacta International S.A. | 2019-09-12 |
| L360 Thigh System (K191587) | Bioness, Inc. | 2019-09-12 |
| UPnRIDE (K182257) | Upnride Robotics , Ltd. | 2019-09-12 |
| PeraMobile and PeraWatch (K183370) | Perahealth, Inc. | 2019-09-11 |
| Ceribell Pocket EEG Device (K191301) | Ceribell, Inc. | 2019-09-11 |
| Catalyst OrthoScience CSR Shoulder System (K191811) | Catalyst Orthoscience, Inc. | 2019-09-11 |
| Neocis Guidance System (NGS) (K191605) | Neocis, Inc. | 2019-09-11 |
| CNAP Monitor (K183521) | Cnsystems Medizintechnik GmbH | 2019-09-11 |
| 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (K191355) | 3M Healthcare | 2019-09-11 |
| BrainScope TBI (K190815) | Brainscope Company, Inc. | 2019-09-11 |
| TurboTemp EZ (K191619) | Zest Anchors, LLC | 2019-09-11 |
| Sterling Supreme Diode Laser (K181614) | CAO Group, Inc. | 2019-09-10 |
| BH Medical Dental Barrier Sleeves and Barrier Film (K190484) | Bh Medical Products Co., Ltd. | 2019-09-10 |
| Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (K191013) | Welch Allyn, Inc. | 2019-09-10 |
| AI-Rad Companion (Cardiovascular) (K183268) | Siemens Medical Solutions USA, Inc. | 2019-09-10 |
| External Counterpulsation System (K190683) | Vamed Medical Instrument Co., Ltd. | 2019-09-10 |
| KOWA nonmyd 8 (K191945) | Kowa Company , Ltd. | 2019-09-10 |
| Pioneer Elite Diode Laser (K181602) | CAO Group, Inc. | 2019-09-10 |
| Precise SHP Diode Laser (K181601) | CAO Group, Inc. | 2019-09-09 |
| Ti3Z Cervical Interbody System (K191354) | Zavation Medical Products, LLC | 2019-09-09 |
| Encompass 15 Channel Head Coil, 3T (K190668) | Qfix | 2019-09-09 |
| Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector (K183444) | Cenorin, LLC | 2019-09-09 |
| Connected OR Hub with Device and Voice Control (K192172) | Stryker | 2019-09-09 |
| Sofacia System (K191421) | Sofwave Medical, Ltd. | 2019-09-09 |
| Focus TENS Therapy, Model PM710-M/-L (K183215) | Omron Healthcare, Inc. | 2019-09-07 |
| Sure-Fine Insulin Syringes (K191531) | Shina Med Corporation | 2019-09-06 |
| Reusable Temperature Probe (K182751) | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-09-06 |
| SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (K183574) | Huntleigh Healthcare , Ltd. | 2019-09-06 |
| Microscope Navigation (K190250) | Brainlab AG | 2019-09-06 |
| Willow Wearable Breast Pump 2.0 (K191577) | Exploramed Nc7, Inc. | 2019-09-06 |
| Klinly Ultrasonic Tongue Cleaner (K181986) | Kea Products, Ltd. | 2019-09-06 |
| Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens (K191121) | Lentechs, LLC | 2019-09-06 |
| Precision S 4K Sinuscope (K191102) | Stryker | 2019-09-06 |
| Secret RF Smartcure Applicator with electrodes (K182355) | Ilooda Co,., Ltd. | 2019-09-06 |
| PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K183516) | Pentax of America, Inc. | 2019-09-06 |
| Lumify Diagnostic Ultrasound System (K192226) | Philips Health Care | 2019-09-06 |
| TTC Phantom Intramedullary Nail System (K191782) | Paragon 28, Inc. | 2019-09-06 |
| Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (K190403) | Ever Global (Vietnam) Enterprise Corporation | 2019-09-06 |
| Gem FlowCoupler System (K190499) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
| Cytomics FC 500 Series (MPL or MCL) Flow Cytometer (K182886) | Beckman Coulter | 2019-09-06 |
| IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435) | Nalu Medical, Inc. | 2019-09-06 |
| Rhino-Laryngo Videoscope Olympus ENF-VT3 (K183416) | Olympus Medical Systems Corp. | 2019-09-06 |
| EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (K183525) | Olympus Medical Systems Corp. | 2019-09-06 |
| Yikang Endotracheal Tube (K190213) | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2019-09-06 |
| Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) (K191845) | Barco N.V. | 2019-09-06 |
| Transvaginal Access Platform (K191294) | Applied Medical Resources Corp. | 2019-09-06 |
| Aquilion ONE (TSX-306A/3) V10.0 (K192188) | Canon Medical Systems Corporation | 2019-09-06 |
| EVO Platform (K192160) | Quanta System Spa | 2019-09-06 |
| Venus Legacy Pro Device (K191528) | Venus Concept USA, Inc. | 2019-09-06 |
| Vacutore Air/Water Bottle Tubing (K191366) | Smartdata Suzhou Co., Ltd. | 2019-09-06 |