| SmartPerfusion (K181966) | Philips Medical Systems Nederlands B.V. | 2018-08-17 |
| Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074) | Simple Science, LLC | 2018-08-17 |
| CBit Series Digital Color Doppler Ultrasound System (K180974) | CHISON Medical Technologies Co., Ltd. | 2018-08-17 |
| Cios Select (K181767) | Siemens Medical Solutions USA, Inc. | 2018-08-17 |
| Ultraxx Nephrostomy Balloon Catheter Set (K181713) | Cook Incorporated | 2018-08-17 |
| NuBorne Infant Warmer (K173516) | International Biomedical | 2018-08-17 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K173773) | Bayer Medical Care, Inc. | 2018-08-17 |
| PreXion 3D Excelsior (K181983) | Prexion Corporation | 2018-08-17 |
| VersaPAP Positive Airway Pressure (PAP) Device (K173918) | Trudell Medical International | 2018-08-17 |
| OSCAR (OSCAR Prime, OSCAR Classic) (K181943) | Genoray Co., Ltd. | 2018-08-17 |
| Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (DEN170078) | Brainways , Ltd. | 2018-08-17 |
| Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor (K180574) | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2018-08-17 |
| BioWaveGO (K180943) | Biowave Corporation | 2018-08-17 |
| Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus (K173638) | Bionime Corporation | 2018-08-17 |
| Actifuse Flow (K181306) | Baxter Healthcare Corporation | 2018-08-17 |
| Optical Topography System ETG-4100 (K172492) | Hitachi Healthcare Americas | 2018-08-17 |
| Electronic Stethoscope DS3011A (K173663) | Imediplus, Inc. | 2018-08-17 |
| BTI Dental Implant System UnicCa (K173257) | B.T.I. Biotechnology Institute, Sl. | 2018-08-17 |
| Biodegradable Nitrile Powder Free Examination Glove (Blue) (K173509) | Hartalega Sdn Bhd | 2018-08-17 |
| Watch-PAT300 (K180775) | Itamar Medical , Ltd. | 2018-08-17 |
| Penumbra System Reperfusion Catheter JET 7 (K173761) | Penumbra, Inc. | 2018-08-17 |
| OsteoReady Dental Implant System (K173575) | Osteoready, LLC | 2018-08-17 |
| Forest Dental Unit (K173608) | Forest Dental Products, Inc. | 2018-08-17 |
| Quantum Workstation 12.1 (K181923) | Spectrum Medical , Ltd. | 2018-08-17 |
| GentleCath Glide Intermittent Urinary Catheter (K181206) | Convatec Limited | 2018-08-16 |
| Bongo (K180619) | Innomed Healthscience, Inc. | 2018-08-16 |
| Cytosponge Cell Collection Device (K181020) | Covidien, LLC | 2018-08-16 |
| Multi-parameter Patient Monitor, models C30 (K173454) | Shenzhen Comen Medical Instruments Co.,Ltd | 2018-08-16 |
| Luminelle DTx Hysteroscopy System (K181909) | Uvision360, Inc. | 2018-08-16 |
| NeuroQ 3.8 (K180077) | Syntermed | 2018-08-16 |
| IGTFusion (K180522) | Igi Technologies | 2018-08-16 |
| RAIN Sheath Transradial (K181592) | Cordis Corporation | 2018-08-15 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System (K181289) | Cepheid | 2018-08-15 |
| BRILLIANT Crios (K181500) | Coltene/Whaledent AG | 2018-08-15 |
| SuperGrow 272, Ultimate 272 (K181308) | Super Grow Lasers | 2018-08-15 |
| Stat Profile Prime Plus Analyzer System (K180428) | Nova Biomedical Corporation | 2018-08-15 |
| BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Microbiologics, Inc. | 2018-08-15 |
| Artis zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |
| InterActive SMARTBase Abutments (K181359) | Implant Direct Sybron Manufacturing, LLC | 2018-08-15 |
| Sonata Sonography-Guided Transcervical Fibroid Ablation System (K173703) | Gynesonics, Inc. | 2018-08-15 |
| Aries® Lumbar Interbodies (K181347) | Osseus Fusion Systems, LLC | 2018-08-15 |
| Mini Ridge Filter and auxiliary functions for PROBEAT-V (K181676) | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 |
| WiScope Digital Endoscope System (K181977) | OTU Medical, Inc. | 2018-08-14 |
| Duo™ Lumbar Interbody Fusion Device (K181792) | Spineology, Inc. | 2018-08-14 |
| Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620) | Tonica Elektronik A/S | 2018-08-14 |
| PleuraFlow System with FlowGlide Extra Drainage Length (K182067) | Clearflow, Inc. | 2018-08-14 |
| Vicks RapidRead Digital Thermometer (K180131) | Kaz USA, Inc., A Helen of Troy Company | 2018-08-14 |
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |
| Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (K181978) | Medyssey USA, Inc. | 2018-08-13 |
| TirboLOX-L Lumbar IBFD (K180990) | Captiva Spine, Inc. | 2018-08-13 |
| KLS Martin Individual Patient Solutions (K180962) | KLS-Martin L.P. | 2018-08-13 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) | Diasorin Molecular, LLC | 2018-08-13 |
| BIAFINE (K173549) | Valeant Pharmaceuticals | 2018-08-13 |
| Deformity Analysis and Correction Software (DACS) and Instrumentation (K180539) | Arrowhead Medical Device Technologies, LLC | 2018-08-13 |
| Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593) | Canon Medical Systems Corporation | 2018-08-13 |
| ONIS-PACS (K181318) | Digitalcore Co., Ltd. | 2018-08-13 |
| Pulse Oximeter (K173123) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-08-13 |
| CARDIOSKIN (K173248) | Bioserenity Sas | 2018-08-11 |
| Portable X-ray System (Model: MiniX-V, Mini X-S) (K181891) | Digimed Co., Ltd. | 2018-08-10 |
| Redi-Spine (K181584) | Innovative Surgical Designs, Inc. | 2018-08-10 |
| Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K181627) | Bausch & Lomb, Incorporated | 2018-08-10 |
| GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (K181151) | ETHICON, Inc. | 2018-08-10 |
| Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (K181130) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-08-10 |
| Natural Cycles (DEN170052) | Natural Cycles Nordic AB | 2018-08-10 |
| Altrix Precision Temperature Management System (K180834) | Stryker Medical | 2018-08-10 |
| iStim S2 OTC Pain Relief TENS (K181849) | Everyway Medical Instruments Co., Ldt. | 2018-08-10 |
| Diana Medication Transfer Set (K170110) | Icu Medical, Inc. | 2018-08-10 |
| CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) | Corelink, LLC | 2018-08-10 |
| Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup (K181253) | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2018-08-10 |
| Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (K180644) | Hartalega Sdn Bhd | 2018-08-10 |
| physiQ Heart Rhythm Module (K180234) | Physiq, Inc. | 2018-08-10 |
| INFINITY Total Ankle System (K181557) | Wrightmedicaltechnologyinc | 2018-08-09 |
| MyPlant II Implant System (K173819) | Hager& Meisinger GmbH | 2018-08-09 |
| FORA GTel Blood Glucose Monitoring System (K173505) | Foracare, Inc. | 2018-08-09 |
| MotoCLIP/HiMAX Step Staple Implant System (K181866) | Crossroads Extremity Systems, LLC | 2018-08-09 |
| Kodiak Spinal Fixation System (K181677) | Alphatec Spine, Inc. | 2018-08-09 |
| Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (K180417) | Berpu Medical Technology Co., Ltd. | 2018-08-09 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430) | Lensar, Inc. | 2018-08-09 |
| Anchor Bolt (as an accessory to Depth Electrodes) (K181544) | Ad-Tech Medical Instrument Corporation | 2018-08-09 |
| Presygen/si-1 (K171245) | Christie Medical Holdings, Inc. | 2018-08-09 |
| EVOS Wrist Fracture Plating System (K181533) | Smith & Nephew, Inc. | 2018-08-09 |
| Titan Ag 200 (K173844) | Specialty Fibres and Materials, Ltd. | 2018-08-09 |
| ICONN Answer II Suture Anchor (K181680) | Iconn Orthopedics, LLC | 2018-08-09 |
| SECULOK™ Suture Anchor (K180759) | U&I Corporation | 2018-08-09 |
| VT - 100, VT - 200 (K173407) | Carilex Medical, Inc. | 2018-08-09 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853) | Alere Scarborough, Inc. | 2018-08-08 |
| 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters (K181836) | Cordis, A Cardinal Health Company | 2018-08-08 |
| F&P SleepStyle (K173193) | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 |
| Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL (K181946) | Thermo Fisher Scientific | 2018-08-08 |
| Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs (K180221) | Smart Glove Corporation Sdn. Bhd. | 2018-08-08 |
| Pure EP (K180805) | Biosig Technologies | 2018-08-08 |
| SmartLinx Vitals Plus Patient Monitoring System (K180734) | Capsule Technologie | 2018-08-08 |
| Ageless Health Medical Digital Thermometer (K172508) | Ageless Health Industrial Co., Ltd. | 2018-08-08 |
| UNIQA Dental Implants System (K180598) | Uniqa Dental, Ltd. | 2018-08-08 |
| EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (K180169) | Imperative Care, Inc. | 2018-08-08 |
| 7D Surgical System Cranial Application (K181041) | 7D Surgical, Inc. | 2018-08-08 |
| EndoWrist Mercury Bipolar Grasper (K180351) | Intuitive Surgical, Inc. | 2018-08-07 |
| VascuEase IC-1200-WH (K180248) | Bio Compression Systems, Inc. | 2018-08-07 |
| Surgical Silver Post Operative Dressing (K180634) | Advanced Medical Solutions, Ltd. | 2018-08-07 |
| AlignRT Plus (K181218) | Vision Rt, Ltd. | 2018-08-07 |