| Biomet Bone Cement R (K172408) | Biomet, Inc. | 2017-10-05 |
| Medacta Shoulder System (K170452) | Medacta International S.A. | 2017-10-05 |
| Reprocessed Covidien Trocar (K172093) | Renovo, Inc. | 2017-10-05 |
| PROLENE Soft Polypropylene Mesh (K172089) | ETHICON, Inc. | 2017-10-05 |
| MagVita TMS Therapy w/MagPro R20 (K172667) | Tonica Elektronik A/S | 2017-10-05 |
| Tahoe Uni Knee System (K170344) | Consensus Orthopedics, Inc. | 2017-10-05 |
| R2P Destination Slender Guiding Sheath (K171491) | Terumo Medical Corporation | 2017-10-05 |
| InSure ONE (K170548) | Enterix, Inc. | 2017-10-05 |
| ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K171689) | Medtronic Sofamor Danek USA, Inc. | 2017-10-05 |
| LinkQuest Diagnostic Ultrasound System model SQ860 (K172059) | Linkquest, Inc. | 2017-10-05 |
| Shoocin Introducer Kit (K172099) | Lepu Medical Technology (Beijing) Co., Ltd. | 2017-10-05 |
| Aquarius 8600 1417WC (K171175) | Imaging Dynamics Company , Ltd. | 2017-10-05 |
| iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit (K172558) | Stryker Corporation | 2017-10-05 |
| SyncVision System (K172574) | Volcano Corporation | 2017-10-05 |
| Vitrea Advanced Visualization, Version 7.6 (K172855) | Vital Images, Inc. | 2017-10-05 |
| Reprocessed CristaCath Diagnostic Electrophysiology Catheter (K171503) | Innovative Health, LLC | 2017-10-05 |
| Gold AQ Blood Glucose Monitoring System (K170264) | Changsha Sinocare, Inc. | 2017-10-05 |
| Ultrasonic Generator (K172691) | Olympus Medical Systems Corp. | 2017-10-04 |
| Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K172607) | Philips Health Care | 2017-10-04 |
| CRE RX Biliary Balloon Dilatation Catheter (K172520) | Boston Scientific Corporation | 2017-10-04 |
| pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (K172289) | Q Urological Corporation | 2017-10-04 |
| HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal (K172671) | Conmed Corporation | 2017-10-04 |
| Philips IntelliSite Pathology Solution (K172174) | Philips Medical Systems Nederland B.V. | 2017-10-04 |
| EMPOWR Porous Knee System (K171991) | Encore Medical L.P. | 2017-10-04 |
| Reprocessed Shavers/Burs (K172092) | Renovo, Inc. | 2017-10-04 |
| ri-former Predictive Thermometer (K171182) | Rudolf Riester GmbH | 2017-10-04 |
| CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (K172022) | Codman & Shurtleff, Inc. | 2017-10-03 |
| Ablatherm Fusion (K172285) | Edap Technomed, Inc. | 2017-10-03 |
| Arisure Closed Vial Adapter (K172884) | Yukon Medical | 2017-10-03 |
| Force Fiber Fusion Suture (K172016) | Teleflex Medical Incorporated | 2017-10-03 |
| Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem (K172684) | Smith & Nephew, Inc. | 2017-10-03 |
| HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) (K172621) | Hardy Diagnostics | 2017-10-03 |
| Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (K171978) | Shenzhen Dongdixin Technology Co., Ltd. | 2017-10-02 |
| Nobilplast Denture Resin (K170375) | Cmp Industries, LLC | 2017-10-02 |
| BRIDALVEIL Occipital Cervical Thoracic System (K171250) | Astura Medical | 2017-10-02 |
| iSurg (K170054) | Jaco, LLC Dba Macan Manufacturing and Bna Burz North America | 2017-10-02 |
| Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl (K170873) | Swissmeditec GmbH | 2017-10-02 |
| Yooeehouse Breast Pump (K163183) | Nantong Poly Technology Co., Ltd. | 2017-10-02 |
| ECG Check - Universal, ECG Check - Universal Plus (K170506) | Cardiac Designs, Inc. | 2017-10-02 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K172210) | Stryker Trauma AG | 2017-10-02 |
| Large Screws Range (K172596) | Newclip Technics | 2017-10-02 |
| Trident® II Acetabular System (K171768) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017-10-02 |
| Carbon Monoxide Breath Sensor System (COBSS) (K171408) | Carrot Sense, Inc. | 2017-09-29 |
| Calix Lumbar Spinal Implant System (K170119) | X-Spine Systems, Inc. | 2017-09-29 |
| BR-FHUS Navigation 1.0 (K171309) | Taihao Medical, Inc. | 2017-09-29 |
| Arisure Dry Spike (K172631) | Yukon Medical | 2017-09-29 |
| Berkeley VC-10 Vacuum Curettage System (K171440) | Gyrus Acmi | 2017-09-29 |
| Photoelectric Therapy System (K172080) | Xstrahl, Ltd. | 2017-09-29 |
| SecurePortIV Catheter Securement Adhesive (K170505) | Adhezion Biomedical, LLC | 2017-09-29 |
| SCARLET AC-T (K172065) | Spineart | 2017-09-29 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K172420) | Wear Safe (Malaysia) Sdn. Bhd. | 2017-09-29 |
| Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K171792) | Alere Scarborough, Inc. | 2017-09-29 |
| CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture (K170166) | Cpt Sutures Co., Ltd. | 2017-09-29 |
| SmartEP (K163326) | Intelligent Hearing Systems | 2017-09-29 |
| Sherlock 3CG Tip Positioning System Stylet (K172397) | C.R. Bard, Inc. | 2017-09-29 |
| Endoscopic Ultrasound Aspiration Needle (K172309) | Micro-Tech (Nanjing) Co., Ltd. | 2017-09-29 |
| Voluson E6, Voluson E8, Voluson E10 (K172342) | GE Healthcare | 2017-09-29 |
| ASPIRE Bellus II (K171463) | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 |
| U2 Diagnostic Ultrasound System (K172380) | Edan Instruments, Inc. | 2017-09-29 |
| Med4 Elite (K171685) | Cool Systems, Inc. (Dba Game Ready) | 2017-09-29 |
| Thommen Implant System (K171795) | Thommen Medical AG | 2017-09-29 |
| AirFit N20 (K171212) | Resmed, Ltd. | 2017-09-28 |
| NuVasive TLX Interbody System (K171633) | Nu Vasive, Incorporated | 2017-09-28 |
| Peel-Away Introducer Set (K170020) | Cook Incorporated | 2017-09-28 |
| SurgiCube (K163455) | Surgicube International B.V. | 2017-09-28 |
| MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm (K171728) | Sterngold Dental, LLC | 2017-09-28 |
| Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) (K161434) | Li-Tek Electronics Technologies | 2017-09-28 |
| Resection Electrodes with HF cable (K171965) | Olympus Winter & Ibe GmbH | 2017-09-28 |
| Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) (K163442) | Modern Medical Equipment Manufacturing Limited | 2017-09-28 |
| FiberTak DX (K172612) | Arthex, Inc. | 2017-09-28 |
| Anatotemp Anatomic Dental Implant Healing Abutment (K171922) | Buckeye Medical Technologies, LLC | 2017-09-28 |
| Digital Thermometer (K170262) | K-Jump Health Co., Ltd. | 2017-09-28 |
| TRAUMACEM™ V+ Injectable Bone Cement (K170802) | Synthes (USA) Products, LLC | 2017-09-28 |
| NuVasive® Precept™ Spinal System (K171894) | Nu Vasive, Incorporated | 2017-09-28 |
| Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (K170498) | Genea Biomedx Pty, Ltd. | 2017-09-28 |
| CUSA Excel+ Ultrasonic Surgical Aspirator System (K172595) | Integra LifeSciences Corporation | 2017-09-28 |
| MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture (K172659) | M/s. Meril Endo Surgery Private Limited. | 2017-09-28 |
| Vitality® Spinal Fixation System, Vitality®+ Power Instrument System (K172275) | Zimmer Biomet Spine, Inc. | 2017-09-27 |
| CRYOFOS (K170810) | Cryofos Medical GmbH | 2017-09-27 |
| Spider Frame External Fixation System (K170482) | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S | 2017-09-27 |
| QiF Blood and Fluid Warmer (K171215) | Quality IN Flow , Ltd. | 2017-09-27 |
| Scopis Extended Instrument Set EM (K171661) | Scopis GmbH | 2017-09-27 |
| FreeStyle Precision Neo Blood Glucose Test Strips (K171941) | Abbott Diabetes Care, Inc. | 2017-09-27 |
| Cetus system, Cetus probe (K170183) | A.R.C Laser GmbH | 2017-09-27 |
| Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL (K172109) | Liofilchem s.r.l. | 2017-09-27 |
| OIC External Fixation System (K171211) | Orthopaedic Implant Company | 2017-09-27 |
| Peerbridge Cor(TM) System (K171936) | Peerbridge Health, Inc. | 2017-09-27 |
| CareView 1800Cw X-ray Flat Panel Detectors (K172581) | Careray Digital Medical System Co., Ltd. | 2017-09-26 |
| SculpSure (K171992) | Cynosure, Inc. | 2017-09-26 |
| Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (K170816) | Brainlab AG | 2017-09-26 |
| CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System (K171107) | Medtronic Sofamor Danek USA, Inc. | 2017-09-26 |
| Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes (K171963) | Hologic, Inc. | 2017-09-26 |
| Vesco Medical Nasoenteric Feeding Tubes (K170162) | Vesco Medical, LLC | 2017-09-26 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) (K172015) | Careglove Global Sdn. Bhd. | 2017-09-26 |
| ROMEO® 2 Posterior Osteosynthesis System (K172101) | Spineart | 2017-09-26 |
| Ecofit® Hip System (K163577) | Implantcast GmbH | 2017-09-25 |
| Electrocardiograph (K171943) | Edan Instruments, Inc. | 2017-09-25 |
| ISEN-Goggles with Data Viewer (K163270) | Isent Tech & Trading Company, Ltd. | 2017-09-25 |
| Exofin Fusion Skin Closure System (K171442) | Chemence Medical, Inc. | 2017-09-25 |