| Avail (K172079) | Omron Healthcare, Inc. | 2017-10-19 |
| Discovery Pico, Discovery Pico Plus (K172376) | Quanta System Spa | 2017-10-19 |
| CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System (K170614) | I-Sens, Inc. | 2017-10-19 |
| Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T (K171017) | Convaid Products, LLC | 2017-10-18 |
| ECG SENTINEL System (K172801) | Cardiomedix, Inc. | 2017-10-18 |
| OrthoView 7.2 (K171068) | Meridian Technique, Ltd. | 2017-10-18 |
| Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (K171125) | Tangible Science, LLC | 2017-10-18 |
| Emit II Plus Oxycodone Assay (K172910) | Siemens Healthcare Diagnostics, Inc. | 2017-10-18 |
| Curve Image 2.0 PACS (K173101) | Curve Dental, Ltd. | 2017-10-18 |
| M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System (K171579) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-18 |
| Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap (K172034) | Stryker Corporation | 2017-10-18 |
| Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (K172608) | Surgical Instrument Service and Savings, Inc. | 2017-10-18 |
| CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (K172203) | Nuance Medical, LLC | 2017-10-18 |
| Liberator Beacon Tip Locking Stylet (K170298) | Cook Incorporated | 2017-10-18 |
| NovaCross Microcatheter (K172297) | Nitiloop , Ltd. | 2017-10-18 |
| OTC Combo TENS/EMS System (K172809) | Well-Life Healthcare Limited | 2017-10-18 |
| ANCHOR Tissue Retrieval System (K172940) | Conmed Corporation | 2017-10-18 |
| Bencox Mirabo Cup System (K172806) | Corentec Co., Ltd. | 2017-10-17 |
| Chitogel Endoscopic Sinus Surgery Kit (K172179) | Chitogel, Ltd. | 2017-10-17 |
| RVS-100 Vital Signs Monitor (K170538) | Rudolf Riester GmbH | 2017-10-17 |
| 585 (K172198) | Quanta System Spa | 2017-10-17 |
| Applanation tonometer AT-1 (K172728) | Takagi Seiko Co., Ltd. | 2017-10-17 |
| CERABIEN ZR (K170834) | Kuraray Noritake Dental, Inc. | 2017-10-17 |
| SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (K160282) | Sd Biosensor | 2017-10-17 |
| EnsoETM (K172493) | Attune Medical | 2017-10-17 |
| 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA (K172817) | Olympus Medical Systems Corp. | 2017-10-17 |
| X-SURGE (K171752) | Genicon, Inc. | 2017-10-17 |
| Solana RSV+hMPV Assay (K171974) | Quidel Corporation | 2017-10-16 |
| AcQMap High Resolution Imaging and Mapping System (K170948) | Acutus Medical, Inc. | 2017-10-16 |
| OptiScanner 5000 Glucose Monitoring System (K162042) | Optiscan Biomedical Corp. | 2017-10-16 |
| BioWick X Implant with Driver (K172186) | Cayenne Medical, Inc. | 2017-10-16 |
| Coaxial Dilator Set (Micro-Introducer) (K172487) | Galt Medical Corp. | 2017-10-16 |
| HylaGuard Moisturizing Cream (K171879) | Founders Science Group, LLC | 2017-10-16 |
| Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag (K172537) | Codman & Shurtleff, Inc. | 2017-10-16 |
| AcQMap 3D Imaging and Mapping Catheter (K170819) | Acutus Medical, Inc. | 2017-10-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y (K172498) | Microlife Intellectual Property GmbH | 2017-10-13 |
| Single Use Hot Biopsy Forceps FD-231 (K171916) | Olympus Medical Systems Corp. | 2017-10-13 |
| Freemie Independence, Freemie Liberty (K172772) | Dao Health | 2017-10-13 |
| micro IPL (K172181) | El Global Trade, Ltd. | 2017-10-13 |
| Electronic Blood Pressure Monitor (K170151) | Shenzhen Pango Electronic Co., Ltd. | 2017-10-13 |
| PAL Multi-Use Cannulas and PAL Manual Wand (K171286) | Microaire Surgical Instruments, LLC | 2017-10-13 |
| SuperNO2VA Device (K163277) | Revolutionary Medical Devices, Inc. | 2017-10-13 |
| Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter (K171548) | Wilson-Cook Medical, Inc. | 2017-10-13 |
| SleepImage System (K163696) | Mycardio, LLC Dba Sleepimage. | 2017-10-13 |
| PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator (K162362) | Pms Tibbi Cihazlar Teknolojisi San VE Tic AS | 2017-10-13 |
| Citryte (K171015) | Di-Chem, Inc. | 2017-10-13 |
| DX-D Imaging Package (K172784) | Agfa Healthcare N.V. | 2017-10-13 |
| Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) (K170233) | Zhanjiang Star Enterprise Co., Ltd. | 2017-10-13 |
| Exciplex308nm (K171702) | Clarteis | 2017-10-13 |
| Senhance Surgical Robotic System (K171120) | Transenterix, Inc. | 2017-10-13 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL (K172454) | Thermo Fisher Scientific | 2017-10-13 |
| CELFIRM (K172023) | VIOL Co., Ltd. | 2017-10-13 |
| Galaxy R Digital Radiography Upgrade (K172435) | Medien International Co, Ltd. | 2017-10-13 |
| NOVOS-NAIL Limb Lengthening System (LLS) (K163653) | Smith & Nephew | 2017-10-13 |
| GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System (K170241) | All Medicus Co., Ltd. | 2017-10-13 |
| AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (K170232) | Boditech Med, Inc. | 2017-10-13 |
| SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (K172197) | Origio A/S | 2017-10-13 |
| CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305) | Datascope Corp. | 2017-10-12 |
| Lucica Glycated Albumin-L (K170147) | Asahi Kasei Pharma Corporation | 2017-10-12 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) (K171874) | Hartalega Sdn Bhd | 2017-10-12 |
| Galaxy UNYCO System (K170146) | Orthofix Srl | 2017-10-12 |
| Aquarius 8600 1417TG and Aquarius 8600 1717TG (K171169) | Imaging Dynamics Company , Ltd. | 2017-10-12 |
| MAGNETOM Terra (K170840) | Siemens Medical Solutions USA, Inc. | 2017-10-12 |
| Mikron Spinal Fixation System (K171497) | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| JUD custom fit condom (K172414) | Global Mailer Partners, LLC | 2017-10-12 |
| Creavo Vitalscan Magnetocardiograph (K170154) | Creavo Medical Technologies, Ltd. | 2017-10-12 |
| SONON Ultrasound Imaging System, Model: 300L (K170085) | Healcerion Co., Ltd. | 2017-10-12 |
| Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs (K171782) | Blue Sail Medical Co.,Ltd | 2017-10-12 |
| Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves (K171279) | Top Glove Sdn. Bhd. | 2017-10-12 |
| Vial Adapter 15mm (K171796) | Medimop Medical Project , Ltd. | 2017-10-12 |
| SKR 3000 (K172793) | Konica Minolta, Inc. | 2017-10-12 |
| Stomach Tube (K162340) | Well Lead Medical Co., Ltd. | 2017-10-11 |
| Nihon Kohden CO2 Monitor (K171765) | Nihon Kohden Corporation | 2017-10-11 |
| Clickfine Pen Needle, Penfine Classic Pen Needle (K171984) | Ypsomed AG | 2017-10-11 |
| NuVasive® Modulus XLIF Interbody System (K172123) | Nu Vasive, Incorporated | 2017-10-11 |
| U by Kotex Click Unscented Menstrual Tampons (K172118) | Kimberly-Clark Corporation | 2017-10-11 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) (K172742) | AtriCure, Inc. | 2017-10-11 |
| higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) (K172739) | Higi Sh, LLC | 2017-10-10 |
| InMode RF System (K171593) | Inmode MD , Ltd. | 2017-10-10 |
| 3M Bair Hugger Model 675 Total Temperature Management System (K171373) | 3M Company | 2017-10-10 |
| XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory (K172724) | Stryker Corporation | 2017-10-10 |
| IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (K171801) | Philips Medizin Systeme Boeblingen GmbH | 2017-10-06 |
| Edge Air Digital Flat Panel X-ray Detector (K172681) | Osko, Inc. | 2017-10-06 |
| Digital Eye Anterior Camera (K170470) | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 |
| Sienna Ultimate Wireless Amplifier (K171397) | Ems Handels Gesellschaft M.B.H. | 2017-10-06 |
| Aquilion Prime SP, TSX-303B/1, v8.4 (K172188) | Toshiba Medical Systems Coroporation | 2017-10-06 |
| Ingenuity TF (K172406) | Philips Medical Systems (Cleveland), Inc. | 2017-10-06 |
| Low Profile Non-Balloon Feeding Device (K170319) | Applied Medical Technology, Inc. | 2017-10-06 |
| U-Motion II Acetabular System— Additional sizes (K170089) | United Orthopedic Corporation | 2017-10-06 |
| MicroMatrix (K172399) | Acell, Inc. | 2017-10-06 |
| Kisses Mini (K170394) | Achimhai Medical Corporation | 2017-10-06 |
| Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System (K170079) | Tyson Bioresearch, Inc. | 2017-10-06 |
| Tamper Evident Cap For use with ENFit Syringes (K170672) | International Medical Industries, Inc. | 2017-10-06 |
| Endoscopic Applicator, 41 cm (K172672) | Micromedics, Inc. (D/B/A Nordson Medical) | 2017-10-06 |
| Edge Digital Flat Panel X-ray Detector (K172682) | Osko, Inc. | 2017-10-06 |
| MSA100BT Peak Flow Meter (K170281) | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 |
| Bilicocoon™ Phototherapy System (K163526) | Neomedlight | 2017-10-06 |
| MT ONE (K172413) | M&T S.R.L. | 2017-10-06 |
| Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves (K172097) | Renovo, Inc. | 2017-10-06 |
| Shanghai Sanyou CARMEN Cervical Fusion System (K163366) | Shanghai Sanyou Medical Co, Ltd. | 2017-10-05 |