| Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K181653) | Ethicon Endo-Surgery, LLC | 2018-09-18 |
| Sypher Spacer System (K181337) | Biogennix, LLC | 2018-09-18 |
| BioSign Flu A+B (K182157) | Princeton BioMeditech Corp. | 2018-09-18 |
| Tandry Locking Plate System (K171904) | Microware Precision Co., Ltd. | 2018-09-18 |
| Endoscopic Linear Cutting Staplers and Loading Units for Single Use (K181620) | Ezisurg (Suzhou) Medical Co., Ltd. | 2018-09-18 |
| Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System (K181390) | OrthoPediatrics Corp. | 2018-09-18 |
| Venacure 1470 Pro (K181632) | Quanta System Spa | 2018-09-17 |
| PALACOS MV (K182260) | Heraeus Medical GmbH | 2018-09-17 |
| DenTek Ultimate Dental Guard (K180933) | Medtech Products, Inc. | 2018-09-17 |
| Ceracell Ortho Foam (K181721) | Curasan AG | 2018-09-17 |
| CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (K173871) | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| ThermaCare Quick Therapy TENS (K181102) | Pfizer, Inc. | 2018-09-15 |
| Impress SFS System (K173910) | Cable Fix Medical, LLC | 2018-09-14 |
| Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A (K182223) | Canon Medical Systems, USA | 2018-09-14 |
| Portable Nebulizer (K180871) | Microbase Technology Corporation | 2018-09-14 |
| LightScalpel (K173827) | Lightscalpel, LLC | 2018-09-14 |
| A-FIT (K173676) | Hironic Co., Ltd. | 2018-09-14 |
| QT Ultrasound Breast Scanner - 1 (K182213) | Qt Ultrasound, LLC | 2018-09-14 |
| DORADOnova MR3T (K173926) | Lap GmbH Laser Applikationen | 2018-09-14 |
| Prime E-CLASS XLPE Liner (K181598) | Microport Orthopedics, Inc. | 2018-09-14 |
| MX40 Mobile Digital X-ray System (K181874) | Huestis Machine Corporation | 2018-09-14 |
| Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182) | Cook Incorporated | 2018-09-14 |
| POLY REJUV (K180875) | Medtek Skincare, LLC | 2018-09-14 |
| DizzyDoctor System 1.0.0 (K182214) | Dizzydoctor Systems, LLC | 2018-09-14 |
| Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (K180369) | Relievant Medsystems | 2018-09-14 |
| DYNA-LINK ELITE Stand-Alone Anterior Lumbar System (K180215) | Life Spine, Inc. | 2018-09-13 |
| MTS Penicillin 0.002- 32 µg/mL (K181889) | Liofilchem s.r.l. | 2018-09-13 |
| Planmeca Viso (K181576) | Planmeca Oy | 2018-09-13 |
| SelectFlex 072 Neurovascular Access System (K181000) | Q'Apel | 2018-09-13 |
| Seal Single Use Biopsy Valve (K182275) | Boston Scientific Corporation | 2018-09-13 |
| RiX70 DC (K182206) | Trident S.R.L | 2018-09-13 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) | KLS-Martin L.P. | 2018-09-13 |
| HySil Impression Materials (K181236) | Osstem Implant Co., Ltd. | 2018-09-13 |
| MOSS VRS Spinal System (K181821) | Biedermann Motech GmbH & Co. KG | 2018-09-13 |
| Sof-Flex Ureteral Stent Set (K180053) | Cook Incorporated | 2018-09-13 |
| TENS device-HeadaTerm, eEspress (K172450) | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 |
| Sorrento Bioglass Bone Graft Substitute (K173933) | Xenco Medical, LLC | 2018-09-13 |
| Spectralis HRA+OCT and variants with OCT Angiography Module (K181594) | Heidelberg Engineering GmbH | 2018-09-13 |
| BioSphere Flex (K173424) | Synergy Biomedical | 2018-09-12 |
| Magnesium (K181748) | Abbott Laboratories | 2018-09-12 |
| PRODENSE Bone Graft Substitute (K181255) | Wrightmedicaltechnologyinc | 2018-09-12 |
| LnK Lumbar Interbody Fusion Cage System (K181380) | L&K BIOMED Co., Ltd. | 2018-09-11 |
| Stryker Pediatric Mandibular Distractor 2 (K181504) | Stryker | 2018-09-11 |
| AirStrip RPM InvisionHeart Adapter (K182226) | Airstrip Technologies, Inc. | 2018-09-11 |
| ECG App (DEN180044) | Apple, Inc. | 2018-09-11 |
| IPL Salon Hair Reduction System (K181568) | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018-09-11 |
| TruBase S (K171532) | Truabutment, Inc. | 2018-09-11 |
| Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (K182196) | Imediplus, Inc. | 2018-09-11 |
| Octane Mechanical Thrombectomy System (K182232) | Vascular Solutions, Inc. | 2018-09-11 |
| Renovis S180 Lateral Lumbar Interbody Fusion System (K181655) | Renovis Surgical Technologies | 2018-09-11 |
| Anchor Tissue Retrieval System by CONMED (K173822) | Conmed Corporation | 2018-09-11 |
| Irregular Rhythm Notification Feature (DEN180042) | Apple, Inc. | 2018-09-11 |
| ProSun sunlamp products, Luxura sunlamp products (K181455) | Prosun International, LLC | 2018-09-10 |
| The Sex Gel (K181078) | Necessaire, Inc. | 2018-09-10 |
| XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415) | Canon Medical Systems Corporation | 2018-09-10 |
| SECULOK™ ACP System (K182055) | U&I Corporation | 2018-09-10 |
| Human Tecar HCR 1002 (K181211) | Unibell S.R.L | 2018-09-10 |
| IntelliSpace Perinatal Rev.K.00 (K173941) | Philips Medizin Systeme Boeblingen GmbH | 2018-09-10 |
| Philips Hemodynamic Application R1.0 (K181311) | Philips Medical Systems Nederlands B.V. | 2018-09-07 |
| Disposable SpO2 Sensors, Reusable SpO2 Sensors (K181270) | Orantech, Inc. | 2018-09-07 |
| Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask (K182079) | Medtec Inc. Dba Civco Medical Solutions | 2018-09-07 |
| R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (K181688) | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-09-07 |
| Exceed Microneedling Device (K180778) | Mt. Derm GmbH | 2018-09-07 |
| syngo.via View&GO (Version VA10A) (K182208) | Siemens Healthcare GmbH | 2018-09-07 |
| ReTrace Ureteral Access Sheath (K181811) | Coloplast A/S | 2018-09-07 |
| INNOVANCE Free PS Ag (K181525) | Siemens Healthcare Diagnostics Products GmbH | 2018-09-07 |
| Bi-Flex Evo (K182144) | Promepla Sam | 2018-09-07 |
| External Fixation System (K173883) | Life Spine, Inc. | 2018-09-07 |
| GLOW800 (K181537) | Leica Microsystems (Schweiz) AG | 2018-09-07 |
| Corin Optimized Positioning System (OPS) Femoral (K181061) | Corin USA | 2018-09-07 |
| CTXX85 (K182147) | Analogic Corporation | 2018-09-07 |
| Multi Modality Viewer (K182230) | Vital Images, Inc. | 2018-09-07 |
| IPL Hair Removal Device Joy Version (K173813) | Shen Zhen Cosbeauty Co., Ltd. | 2018-09-07 |
| RetCam 3 ; RetCam Shuttle ; RetCam Portable (K182263) | Natus Medical Incorporated | 2018-09-07 |
| SILVERBACK Gorilla Plating System (K182148) | Paragon 28, Inc. | 2018-09-07 |
| Ultravision™ Visual Field Clearing System (K182053) | Alesi Surgical, Ltd. | 2018-09-07 |
| mediCAD 4.0 (K170702) | Medicad Hectec GmbH | 2018-09-07 |
| AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (K181423) | Amsino International, Inc. | 2018-09-07 |
| Ultrasound System SONIMAGE HS1 (K182153) | Konica Minolta, Inc. | 2018-09-06 |
| Dual output digital therapy massager (K172834) | Shenzhen Osto Technology Co., Ltd. | 2018-09-06 |
| Optima XR240amx (K182234) | Ge Medical Systems, LLC | 2018-09-06 |
| Trabis (K173893) | Coligne AG | 2018-09-06 |
| Provata Implant System (K180465) | Southern Implants (Pty), Ltd. | 2018-09-06 |
| Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (K181558) | Gelflex Laboratories | 2018-09-06 |
| Spinal Elements Cerclage System (K180728) | Spinal Elements, Inc. | 2018-09-06 |
| Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (K181128) | Contego Medical, LLC | 2018-09-06 |
| Sebacia Microparticles (K181518) | Sebacia, Inc. | 2018-09-06 |
| AMSafe Sure-Lok Needle-Free Connector (K173665) | Amsino International, Inc. | 2018-09-05 |
| HD-500 Video Endoscope System (K173921) | Sonoscape Medical Corp. | 2018-09-05 |
| Iridex TruFocus LIO Premiere (K181662) | Iridex Corporation | 2018-09-05 |
| Masimo Acoustic Respiration Sensors, infant and neonate (K173976) | Masimo Corporation | 2018-09-05 |
| Kiierr 272 Laser, Kiierr 148 Laser (K181878) | Kiierr International, LLC | 2018-09-05 |
| Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD (K182138) | Eleckta Limited | 2018-09-05 |
| AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (K181814) | Amsino International, Inc. | 2018-09-04 |
| IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (K181314) | Philips Medizin Systeme Boeblingen GmbH | 2018-09-04 |
| Surveyor Patient Monitor (K173765) | Mortara Instrument, Inc. | 2018-09-04 |
| Exactech Alteon Monobloc Revision Stem (K181532) | Exactech, Inc. | 2018-09-04 |
| NeoBase 2 Non-derivatized MSMS Kit (K173568) | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 |
| ECHOLASER X4 (K181510) | El.En Electronic Engineering Spa | 2018-09-04 |
| EUSRA RF Electrode (K181249) | Starmed Co., Ltd. | 2018-09-04 |