| Optilite High Sensitivity C-Reactive Protein Kit (K180099) | The Binding Site Group , Ltd. | 2018-10-12 |
| PENTAX Video Upper G.I. Scope EG34-i10 (K180292) | Pentax Medical of America, Inc. | 2018-10-12 |
| OSSDSIGN Cranioplug (K181539) | Ossdsign AB | 2018-10-12 |
| Life Spine Laminoplasty System (K181717) | Life Spine, Inc. | 2018-10-12 |
| Juell 3D Volo Base (K181220) | Park Dental Research Corporation | 2018-10-12 |
| BKS Revision Sleeves System (K181569) | Ortho Development Corporation | 2018-10-12 |
| EIT Cellular Titanium® Lumbar Cage LLIF (K181644) | Eit Emerging Implant Technologies GmbH | 2018-10-12 |
| Integra TITAN Reverse Shoulder System (K181999) | Integra LifeSciences Corporation | 2018-10-12 |
| Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap (K182536) | Exactech, Inc. | 2018-10-12 |
| Thorecon Rigid Fixation System (K181607) | A & E Medical Corporation | 2018-10-12 |
| Percuvance Percutaneous Surgical System (K181852) | Teleflexmedical, Inc. | 2018-10-12 |
| AG 100s (K180991) | Hospitech Respiration , Ltd. | 2018-10-12 |
| X-BOLT Hip Fracture Fixation System (K181640) | X-Bolt Orthopaedics | 2018-10-12 |
| b-ONE Total Knee System (K180446) | B-One Ortho, Corp. | 2018-10-12 |
| ADAPT for Gamma3, Gamma3 (K181848) | Stryker GmbH | 2018-10-12 |
| uMI 550 PET/CT System (K182237) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-12 |
| Piccolo Composite® Plate System (K182015) | CarboFix Orthopedics , Ltd. | 2018-10-11 |
| OmniPore DUROMAX Surgical Implants (K180249) | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018-10-11 |
| NuFACE Trinity (K181008) | Carol Cole Company Dba Nuface | 2018-10-11 |
| Ormco Spark Aligner System (K182826) | Sybron Dental Specialties | 2018-10-11 |
| LS OIL (K173920) | J. Morita USA, Inc. | 2018-10-11 |
| Sirona Dental CAD/CAM System (K181520) | Dentsply Sirona | 2018-10-11 |
| Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (K180680) | Laclede, Inc. | 2018-10-11 |
| Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) (K181426) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2018-10-11 |
| SCARLET SRF (K180872) | VIOL Co., Ltd. | 2018-10-11 |
| E-CUBE 8 (K181617) | Alpinion Medical Systems Co., Ltd. | 2018-10-11 |
| OnePacs System (K181460) | Onepacs, LLC | 2018-10-11 |
| MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151) | Ctl Medical Corporation | 2018-10-11 |
| AxSOS 3 Ti (K181091) | Stryker GmbH | 2018-10-11 |
| NeoMatriX Wound Matrix (K181330) | Nextgen Biologics, Inc. | 2018-10-11 |
| DemeTECH PTFE Nonabsorbable Surgical Suture (K181578) | Demetech Corporation | 2018-10-11 |
| Fingertip Pulse Oximeter (K181503) | Beijing Choice Electronic Technology Co., Ltd. | 2018-10-11 |
| Voyant Electrosurgical Generator (K182244) | Applied Medical Resources Corp. | 2018-10-11 |
| Ergoline Prestige 1600 Hybrid Performance (K180555) | Jk Holding GmbH | 2018-10-11 |
| Geminus Volar Distal Radius Plate System (K182492) | Skeletal Dynamics, LLC | 2018-10-10 |
| ClotTriever Thrombectomy System (K182531) | Inari Medical | 2018-10-10 |
| SBG Blue Nitrile Powder Free Medical Examination Glove (K180467) | Showa Best Glove, Inc. | 2018-10-10 |
| Temperature Probe (K173194) | Orantech, Inc. | 2018-10-10 |
| Cellent Spinal Systems (K172826) | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2018-10-10 |
| CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (K181038) | Cormatrix Cardiovascular, Inc. | 2018-10-10 |
| BioHorizons Tapered IM Implants (K182070) | BioHorizons Implant Systems, Inc. | 2018-10-10 |
| SBG Black Nitrile Powder Free Medical Examination Glove (K180468) | Showa Best Glove, Inc. | 2018-10-10 |
| Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (K181774) | Teleflex Medical Incorporated | 2018-10-10 |
| Sterile High-pressure Angiographic Syringes for Single-use (K182289) | Shenzhen Baoan Medical Supplies Co., Ltd. | 2018-10-10 |
| Elvie Pump (K181863) | Chiaro Technology Limited | 2018-10-10 |
| Ziostation2 (K181892) | Ziosoft, Inc. | 2018-10-09 |
| Scarlet AL-T (K181818) | Spineart | 2018-10-09 |
| Senhance Surgical System (K181517) | Transenterix, Inc. | 2018-10-09 |
| Swiss LithoClast Trilogy (K182490) | E.M.S Electro Medical Systems S.A | 2018-10-09 |
| Vinyl Patient Examination Gloves (K182117) | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 2018-10-06 |
| Bluetooth blood pressure monitor (K182018) | Shenzhen Kingyield Technology Co., Ltd. | 2018-10-06 |
| NuVasive Cohere Thoracolumbar Interbody System (K181860) | Nu Vasive, Incorporated | 2018-10-05 |
| Sense System with IBT Electrodes (K182112) | Infinite Biomedical Technologies, LLC | 2018-10-05 |
| SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (K181531) | Spineex, Inc. | 2018-10-05 |
| EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (K181603) | K2m, Inc. | 2018-10-05 |
| SHINY RPL System (K181868) | Ids, Ltd. | 2018-10-05 |
| ORTHOLOC SPS Shoulder Plating System (K181587) | Tornier, Inc. | 2018-10-05 |
| Royal Flush Plus High-Flow Catheter (K180054) | Cook Incorporated | 2018-10-05 |
| Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) | Avenu Medical, Inc. | 2018-10-05 |
| GORE Tri-Lumen Catheter (K180919) | W. L. Gore and Associates, Inc. | 2018-10-05 |
| B-Laser Atherectomy System (K181642) | Eximo Medical, Ltd. | 2018-10-05 |
| Bose Hearing Aid (DEN180026) | Bose Corporation | 2018-10-05 |
| Straumann SC Variobase Abutments (K173945) | Institut Straumann AG | 2018-10-05 |
| MAGNETOM Sola (K181322) | Siemens Medical Solutions USA, Inc. | 2018-10-05 |
| Prase MIS Spinal System (K182059) | Gbs Commonwealth Co., Ltd. | 2018-10-04 |
| Ureteric Catheters (K182122) | Coloplast Corp. | 2018-10-04 |
| WishBone Medical Plate and Screw System (K180736) | Wishbone Medical, Inc. | 2018-10-04 |
| Rhino-Laryngo Fiberscope Olympus ENF-GP2 (K181240) | Olympus Medical Systems Corp. | 2018-10-04 |
| POWEREASE System (K182436) | Medtronic Sofamor Danek USA, Inc. | 2018-10-04 |
| Diazyme 1,5-AG Assay (K180209) | Diazyme Laboratories, Inc. | 2018-10-04 |
| HYBRID Guidewire (K182337) | Balt USA, LLC | 2018-10-04 |
| SYMPHONY™ OCT System (K181949) | Medos International SARL | 2018-10-04 |
| PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K182533) | Pixxgen Corporation | 2018-10-04 |
| MAGLUMI 2000 FT4 (K182423) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 |
| CURA 16; ScintCare CT16 (K173076) | Fmi Medical Systems, Inc. | 2018-10-04 |
| Encompass SRS Headframe ; Encompass MR SRS Headframe (K182189) | Qfix | 2018-10-04 |
| uMR 790 (K181371) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| uMR 780 (K181370) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device (K181903) | Varian Medical Systems, Inc. | 2018-10-03 |
| ARIX Clavicle System (K180972) | Jeil Medical Corporation | 2018-10-03 |
| Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (K182050) | Siemens Medical Solutions USA, Inc. | 2018-10-03 |
| Outlet Sacroiliac Joint Fusion System (K181881) | Sij Surgical | 2018-10-03 |
| Caretaker Remote Display App and Caretaker Software Library (K181196) | Caretaker Medical, LLC | 2018-10-03 |
| FIREFLY® Midline Navigation Guide (K181883) | Mighty Oak Medical, Inc. | 2018-10-03 |
| Vinyl Patient Examination Gloves (K182115) | Pingan Medical Products Co., Ltd. | 2018-10-03 |
| 2MP Color LCD Monitor CL-R211 (K182539) | Jvckenwood Corporation | 2018-10-03 |
| On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System (K181527) | ACON Laboratories, Inc. | 2018-10-03 |
| IS-III active System (K181138) | Neobiotech Co., Ltd. | 2018-10-03 |
| Deka Smartxide2 Trio (K181867) | El.En Electronic Engineering Spa | 2018-10-02 |
| Voyant System (K181885) | Viseon, Inc. | 2018-10-02 |
| Infrared Ear Thermometer (K181081) | Joytech Healthcare Co. , Ltd. | 2018-10-02 |
| KLOCKNER SURGICAL BOX (K173642) | SOADCO, S.L. | 2018-10-02 |
| FUJIFILM Duodenoscope Model (K182051) | Fujifilm Corporation | 2018-10-02 |
| NOxBOXi Nitric Oxide Delivery System (K171696) | Praxair Distribution, Inc. | 2018-10-02 |
| StrataMR guider tool (K181622) | Medtronic Neurosurgery | 2018-10-01 |
| MPS2 Myocardial Protection System Console (K173716) | Quest Medical, Inc. | 2018-10-01 |
| AMSure Hydrophilic Intermittent Catheter (K181445) | Amsino International, Inc. | 2018-10-01 |
| BioHorizons CAD/CAM Bars (K180998) | BioHorizons Implant Systems, Inc. | 2018-09-28 |
| Acessa ProVu System (K181124) | Acessa Health, Inc. | 2018-09-28 |
| Orthocaps Twinaligner (K180241) | Ortho Caps GmbH | 2018-09-28 |