| FUJIFILM Video Bronchoscopes (K182253) | Fujifilm Corporation | 2019-04-04 |
| DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (K183377) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-04 |
| PYRAMESH™ Implant System (K183197) | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 |
| Dome Electrode (K190416) | Coapt, LLC | 2019-04-04 |
| Erbe APCapplicators (K183445) | Erbe Elektromedizin GmbH | 2019-04-04 |
| Pixx2430 Digital Diagnostic X-Ray Receptor Panel (K190691) | Pixxgen Corporation | 2019-04-04 |
| GMC Upper Arm Automatic Blood Pressure Monitor (K181931) | Gmc, Inc. | 2019-04-04 |
| CleverLock Guidewire Locking Device and Biopsy Cap (K190164) | Olympus Surgical Technologies America | 2019-04-04 |
| Infrared thermometer (K182597) | Shenzhen Pango Electronic Co., Ltd. | 2019-04-03 |
| VITROS XT Chemistry Products GLU-Ca Slides (K190520) | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| HORIZON TMS Therapy System with Navigation (K183376) | Magstim Company, Ltd. | 2019-04-03 |
| Monster® Screw System (K190586) | Paragon 28, Inc. | 2019-04-03 |
| iFuse Implant System® (K190230) | SI-BONE, Inc. | 2019-04-03 |
| Karma® Fixation System (K190289) | Spinal Elements, Inc. | 2019-04-03 |
| Bio-Medicus Insertion Kit (K190557) | Medtronic, Inc. | 2019-04-03 |
| LINK GEMINI SL Total Knee System (K182872) | Waldemar Link GmbH & Co. KG | 2019-04-03 |
| DAEHAN Disposable CUP Electrodes (K180232) | Daehan Medical Systems Co., Ltd. | 2019-04-03 |
| CONCORDE LIFT (K182349) | Medos International SARL | 2019-04-03 |
| FlareHawk Interbody Fusion System (K183184) | Integrity Implants, Inc. | 2019-04-03 |
| Ilumien Optis, Optis Integrated, Optis Mobile (K183320) | St. Jude Medical (Now Abbott Medical) | 2019-04-02 |
| ARIETTA 50 (K190248) | Hitachi Healthcare Americas | 2019-04-02 |
| AcQMap High Resolution Imaging and Mapping System (K190131) | Acutus Medical, Inc. | 2019-04-02 |
| Zimmer Biomet Ceramic Heads (K181171) | Zimmer, Inc. | 2019-04-02 |
| FUJIFILM Endoscope Model EG-740N (K182836) | Fujifilm Corporation | 2019-04-02 |
| Le'Pen (K181597) | Kmihh, Ltd. | 2019-04-01 |
| Bencox Mirabo Cup Multi Hole (K182221) | Corentec Co., Ltd. | 2019-04-01 |
| Vantage Total Ankle Flat Cut Talar Components (K183343) | Exactech, Inc. | 2019-04-01 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K190180) | Integra LifeSciences Corporation | 2019-04-01 |
| 7400 Ultrasound Systems (K190447) | Navigant Consulting - on Behalf of Esaote S.P.A. | 2019-04-01 |
| Microperimeter MP-3, Microperimeter MP-3 Type S (K190198) | Nidek Co., Ltd. | 2019-04-01 |
| DBSWIN and VISTAEASY Imaging Software (K190629) | Durr Dental SE | 2019-04-01 |
| AggreGuide A-100 ADP (K181777) | Aggredyne, Inc. | 2019-03-29 |
| Loop System (K181352) | Spry Health, Inc. | 2019-03-29 |
| Monaco RTP System (K190178) | Elekta, Inc. | 2019-03-29 |
| Thoracic VCAR with GSI Pulmonary Perfusion (K183210) | GE Medical Systems SCS | 2019-03-29 |
| Delphos Implants Rigid Fixation System (K182609) | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019-03-29 |
| Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (K181770) | Cook Incorporated | 2019-03-29 |
| Micro Transgastric-Jejunal Feeding Device (K183508) | Applied Medical Technology, Inc. | 2019-03-29 |
| Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly (K183596) | Total Joint Orthopedics, Inc. | 2019-03-29 |
| Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand (K182164) | Ecolab, Inc. | 2019-03-29 |
| Pusen Eview Medical Video Endoscope Image Processor (K190648) | Zhuhai Pusen Medical Technology Co., Ltd. | 2019-03-29 |
| CS-series-FP with Optional ROI Accessory CA-100S (K182834) | Omega Medical Imaging, LLC | 2019-03-29 |
| Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579) | Boston Scientific Neuromodulation | 2019-03-29 |
| BL-Cart IOL Delivery Cartridge (K182965) | Ast Products, Inc. | 2019-03-29 |
| ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K182123) | Advin Biotech, Inc. | 2019-03-29 |
| 3880 MRI Patient Monitoring System (K180903) | Iradimed Corporation | 2019-03-29 |
| Reflect Implant System (K180924) | Ids - Integrated Dental Systems | 2019-03-29 |
| Confirm Rx Insertable Cardiac Monitor (K182981) | Abbott | 2019-03-29 |
| BTL-084 (K190023) | BTL Industries, Inc. | 2019-03-29 |
| Freedom Spinal Cord Stimulator (SCS) System (K182720) | Stimwave Technologies Incorporated | 2019-03-29 |
| Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs (K182176) | Pt. Medisafe Technologies | 2019-03-28 |
| Leica FL400 (DEN180024) | Leica Microsystems (Schweiz) AG | 2019-03-28 |
| AirSeal (K190303) | Conmed Corporation | 2019-03-28 |
| Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System (K190186) | Edan Instruments, Inc. | 2019-03-28 |
| LOADPRO™ Intraoperative Rod Strain Sensor (DEN180012) | Intellirod Spine, Inc. | 2019-03-28 |
| V.A.C. DERMATAC Drape (K181505) | Kci USA, Inc. | 2019-03-28 |
| FUJIFILM Duodenoscope Model (K181745) | Fujifilm Corporation | 2019-03-28 |
| eKuore One electronic interface for stethoscope (K181882) | Chip Ideas Electronics S.L. | 2019-03-27 |
| WOLF Thrombectomy Device (K182835) | 880 Medical, LLC | 2019-03-27 |
| VITROS XT Chemistry Products TRIG-CHOL Slides (K190490) | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 |
| Mimics Medical (K183105) | Materialise NV | 2019-03-27 |
| Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) (K182738) | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 |
| Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (K190073) | Current Health , Ltd. | 2019-03-27 |
| Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735) | Cook Incorporated | 2019-03-27 |
| AMSCO 600 Steam Sterilizer (K183410) | STERIS Corporation | 2019-03-27 |
| Responsive Arthroscopy Wedge Push-In Suture Anchors (K190446) | Responsive Arthroscopy, LLC | 2019-03-27 |
| Tyto Thermometer (K190242) | Tyto Care , Ltd. | 2019-03-27 |
| MiMo(TM) Negative Pressure Wound Therapy System (K181929) | Baymax Research, Inc. | 2019-03-27 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit (K190302) | Centers for Disease Control and Prevention | 2019-03-27 |
| Accutorr 7/VS-900/VS-900c Vital Signs Monitor (K182821) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-27 |
| Arthrex TensionLoc System (K183628) | Arthrex, Inc. | 2019-03-26 |
| SM Electrodes (K183154) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-03-26 |
| OTIS Optical Coherence Tomography SYstem (K190404) | Perimeter Medical Imaging, Inc. | 2019-03-26 |
| Synapse PACS (K190232) | Fujifilm Corporation | 2019-03-26 |
| WaveLight FS200 Patient Interface (K190392) | Alcon Laboratories, Inc. | 2019-03-26 |
| transGlideXT Expandable Introducer (K181817) | Transaortic Medical, Inc. | 2019-03-26 |
| Electric Handpiece Motor (K181858) | W&H Dentalwerk Buermoos GmbH | 2019-03-26 |
| Velano Vascular Q2 Extension Set (K182897) | Velano Vascular | 2019-03-26 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Dental Pain Eraser (K182947) | Synapse Dental, LLC | 2019-03-26 |
| InTouch Thermal Camera (K181716) | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019-03-25 |
| Rezum Delivery Device, Rezum Generator (K190093) | Nxthera (A Boston Scientific Company) | 2019-03-25 |
| Ballancer Gold, 1212 (K190015) | Mego Afek AC , Ltd. | 2019-03-25 |
| MUTARS Proximal Femur Replacement System (K181778) | Implantcast GmbH | 2019-03-25 |
| AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905) | Boston Scientific Corporation | 2019-03-25 |
| Arm Blood Pressure Monitor (K183491) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2019-03-24 |
| MTS Gentamicin 0.016 - 256 µg/mL (K190252) | Liofilchem s.r.l. | 2019-03-22 |
| Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs (K182554) | He Chuang Plastic & Rubber Co., Ltd. | 2019-03-22 |
| EnVisio Navigation Sytem (K183400) | Elucent Medical, Inc. | 2019-03-22 |
| OsteoCentric Bone Plate and Screw System (K190430) | Osteocentric Trauma | 2019-03-22 |
| Shiley Neonatal/Pediatric Tracheostomy Tube (K182861) | Covidien | 2019-03-22 |
| Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile (K183608) | Scientia Vascular, LLC | 2019-03-22 |
| Nalu Neurostimulation System (K183047) | Boston Scientific Neuromodulation | 2019-03-22 |
| Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors (K181738) | Surgical Instrument Service and Savings Inc (Dba Medline | 2019-03-22 |
| Polyethylene Catheter (K181722) | Cook Incorporated | 2019-03-22 |
| Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line (K181624) | Oridion Medical 1987 , Ltd. | 2019-03-22 |
| OARtrac System (K182395) | Radialdyne, LLC | 2019-03-22 |
| ROSA ONE Spine application (K182848) | Medtech S.A | 2019-03-22 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (K190104) | Steris Corporations | 2019-03-22 |
| Telescope Guide Extension Catheter (K183353) | Medtronic, Inc. | 2019-03-22 |