| Digital Thermometer (K172121) | Fudakang Industrial Co., Ltd. | 2018-06-07 |
| Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (K180612) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2018-06-07 |
| VERASENSE for Zimmer Biomet Persona (K180459) | Orthosensor, Inc. | 2018-06-07 |
| Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (K180188) | Genea Biomedx Pty, Ltd. | 2018-06-07 |
| FOCAL ONE (K172721) | Edap Technomed, Inc. | 2018-06-07 |
| AT 030 (K180839) | Carl Zeiss Meditec, AG | 2018-06-07 |
| Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator (K180956) | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-06-07 |
| Paxman Scalp Cooler (K173032) | Paxman Coolers Limited | 2018-06-07 |
| QLAB Advanced Quantification Software (K181264) | Philips Ultrasound, Inc. | 2018-06-07 |
| Pakter Curved Needle Set (K173155) | Cook Incorporated | 2018-06-07 |
| TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) (K180122) | Medtronic, Inc. | 2018-06-07 |
| Tetric CAD (K173573) | Ivoclar Vivadent, AG | 2018-06-07 |
| Guarded Luer Connector (K173577) | International Medical Industries, Inc. | 2018-06-07 |
| Orthopantomograph OP 3D (K180947) | Palodex Group OY | 2018-06-07 |
| Sentry IVC Filter (K181202) | Novate Medical , Ltd. | 2018-06-06 |
| EchoMark, EchoMark LP (K180621) | Sonavex, Inc. | 2018-06-06 |
| uMR 560 (K180926) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| truSculpt RF Device; truSculpt; truSculpt 3D (K180709) | Cutera, Inc. | 2018-06-06 |
| uMR 570 (K180925) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| Sterilization Pouch/Roll Made with Tyvek (K180672) | Sigma Medical Supplies Corporation | 2018-06-06 |
| Coconut Infused Hybrid Personal Lubricant (K180712) | United Consortium | 2018-06-06 |
| T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K180436) | Stryker Trauma GmbH | 2018-06-06 |
| POWDER FREE LATEX EXAMINATION GLOVE (K173053) | Professional Latex Sdn Bhd | 2018-06-06 |
| SD1 Ultrasonic Pocket Doppler (K172780) | Edan Instruments, Inc. | 2018-06-06 |
| ARK Fentanyl Assay (K180427) | Ark Diagnostics, Inc. | 2018-06-06 |
| SALVATION External Fixation System (K180832) | Wrightmedicaltechnologyinc | 2018-06-06 |
| VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (K172221) | Taidoc Technology Corporation | 2018-06-06 |
| Balego TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) | Everyway Medical Instruments Co., Ldt. | 2018-06-06 |
| LungQ Software (K173821) | Thirona Corporation | 2018-06-05 |
| SuperBall Meniscal Repair System (K180191) | Arcuro Medical , Ltd. | 2018-06-05 |
| Oximeter (K173045) | Shenzhen Greatmade Tech Limited | 2018-06-05 |
| SIGMA Sterilization Pouch and Roll (K180661) | Sigma Medical Supplies Corp. | 2018-06-05 |
| Curve Positive Airway Pressure System (DEN170089) | Fresca Medical | 2018-06-05 |
| Straumann BLX Implant System (K173961) | Institut Straumann AG | 2018-06-05 |
| Vbeam Prima Laser System (K180593) | Syneron-Candela | 2018-06-05 |
| TAMA BEMS device (K173093) | Tama Research Corporation | 2018-06-05 |
| ImmuGlo HEp-2 Elite IFA (K172745) | Immco Diagnostics, Inc. | 2018-06-05 |
| Lunoa System (K180608) | Nightbalance BV | 2018-06-05 |
| BUHLMANN fCAL ELISA (K181012) | Buhlmann Laboratories AG | 2018-06-04 |
| VariAx 2 System (K180500) | Stryker GmbH | 2018-06-04 |
| reVive Light Therapy LED Cleansing System (K180447) | Led Technologies, Inc. | 2018-06-04 |
| Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (K171609) | Cook Incorporated | 2018-06-04 |
| SmartClip Soft Tissue Marker (K180640) | Elucent Medical, Inc. | 2018-06-04 |
| Silicone Foley Catheter for single use (K172807) | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 |
| Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder (K172763) | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-06-04 |
| Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System (K180855) | Kci USA, Inc. | 2018-06-01 |
| Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters (K172410) | Smiths Medical Asd, Inc. | 2018-06-01 |
| Oxygen Concentrator (K172234) | Sysmed (China) Co., Ltd. | 2018-06-01 |
| UF(II) Wide Fixture (K173975) | Dio Corporation | 2018-06-01 |
| Smart Moves Complete (K172765) | Great Lakes Orthodontics, Ltd. | 2018-06-01 |
| CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (K180238) | Biosense Webster, Inc. | 2018-06-01 |
| Omnipod DASH Insulin Management System (K180045) | Insulet Corporation | 2018-06-01 |
| Bowel Management Device, Bowel Management Irrigation Set (K180026) | Applied Medical Technology, Inc. | 2018-06-01 |
| InMode System with Fractora3D/3D-90 Applicators (K180189) | Inmode MD , Ltd. | 2018-06-01 |
| Silverwear Silver Pro Garment Device (K171798) | Media Plus, LLC | 2018-06-01 |
| Kenz Cardico1211 (K172068) | Suzuken Co., Ltd. | 2018-06-01 |
| NEOSHIELD (K172499) | JMS North America Corporation | 2018-06-01 |
| Colonic Plus Regular, Small, and Straight Shape Hydrokit (K180800) | Colonic Plus | 2018-06-01 |
| Hair Up (K180617) | Y & J Bio Co., Ltd. | 2018-06-01 |
| PanNAT STEC Test (K173330) | Micronics, Inc. | 2018-06-01 |
| BioNude Lubricant (K180136) | Good Clean Love, Inc. | 2018-06-01 |
| Single Use MultiClip Device (K180325) | Micro-Tech (Nanjing) Co., Ltd. | 2018-06-01 |
| Interventional Workspot (K181177) | Philips Medical Systems Nederland B.V. | 2018-05-31 |
| Sternal Cable System (K180582) | A & E Medical Corporation | 2018-05-31 |
| ETCO2 Sensor (K171828) | Orantech, Inc. | 2018-05-31 |
| Single Use Arthroscopic Electrode (with Pencil) (K170703) | Modern Medical Equipment Manufacturing Limited | 2018-05-31 |
| ACUSON SC2000 Diagnostic Ultrasound System (K181098) | Siemens Medical Solutions USA, Inc. | 2018-05-31 |
| ATEC Universal Spacer System (K180480) | Alphatec Spine, Inc. | 2018-05-31 |
| AEVUMED PHANTOM Suture Anchors (K180464) | Aevumed, Inc. | 2018-05-31 |
| SOMAVAC Device (K180606) | Somavac Medical Solutions, Inc. | 2018-05-31 |
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906) | Intuitive Surgical, Inc. | 2018-05-31 |
| CARDIOSAVE Intra-Aortic Balloon Pump (K181122) | Datascope Corp. | 2018-05-31 |
| ToFscan (K172690) | Idmed | 2018-05-31 |
| EndoWrist 5mm Thoracic Grasper (K173415) | Intuitive Surgical, Inc. | 2018-05-31 |
| EVEREST Spinal System (K181188) | K2m, Inc. | 2018-05-30 |
| Playtex Stella Tampons (K180167) | Playtex Manufacturing, Inc. | 2018-05-30 |
| Retia 2 (K180293) | Centervue S.P.A. | 2018-05-30 |
| Legend Acetabular Liners (K173951) | Ortho Development Corporation | 2018-05-30 |
| MN-111 (K172825) | W&H Sterilization S.R.L. | 2018-05-30 |
| ANEROID SPHYGMOMANOMETER (K173246) | Wenzhou Bokang Instruments Co., Ltd. | 2018-05-30 |
| ScioCardio ECG Transmitter (K171019) | Synergen Technology Labs, LLC | 2018-05-30 |
| KATOR Suture Anchor (K173269) | Kator, LLC | 2018-05-30 |
| MICRORAPTOR REGENESORB Suture Anchor (K180361) | Smith and Nephew, Inc. | 2018-05-30 |
| Pure Flow External Counter-Pulsation Device (K173483) | Xtreem Pulse, LLC | 2018-05-30 |
| AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (K180572) | Supersonic Imagine | 2018-05-29 |
| Dr's Light2 (K173157) | Good Doctors Co., Ltd. | 2018-05-29 |
| VERIFY Spore Test Strip for S40 Sterilant (K180553) | STERIS Corporation | 2018-05-29 |
| Belun Ring (K180174) | Belun Technology Company Limited | 2018-05-29 |
| SpineKure Kyphoplasty System (K172871) | Hanchang Co., Ltd. | 2018-05-29 |
| Tri-Ad 2.0 Adams Tricuspid Band (K181132) | Medtronic | 2018-05-29 |
| ProtekDuo Mini Veno-Venous Cannula Set (K181150) | Cardiacassist, Inc. | 2018-05-25 |
| DripAssist Plus (K172242) | Shift Labs, Inc. | 2018-05-25 |
| STAR 65 (K172147) | Skanray Technologies Pvt, Ltd. | 2018-05-25 |
| VORTRAN Cuff Inflator (VCI) (K173914) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (K181082) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 |
| Automatic Tissue Processing Unit (K172717) | Bsl Co. | 2018-05-25 |
| FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711) | Fujifilm Corporation | 2018-05-25 |
| SURECELL Gelling Fiber Wound Dressing (K173005) | Jiangsu Newvalue Medical Producst Co.,Ltd | 2018-05-25 |
| ClearGuard HD Antimicrobial Barrier Cap (K180111) | Pursuit Vascular, Inc. | 2018-05-25 |
| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |