| K182176 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies Mar 28, 2019 |
| K181505 — V.A.C. DERMATAC Drape | Kci USA, Inc. Mar 28, 2019 |
| K190186 — Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Edan Instruments, Inc. Mar 28, 2019 |
| K190303 — AirSeal | Conmed Corporation Mar 28, 2019 |
| DEN180012 — LOADPRO Intraoperative Rod Strain Sensor | Intellirod Spine, Inc. Mar 28, 2019 |
| DEN180024 — Leica FL400 | Leica Microsystems (Schweiz) AG Mar 28, 2019 |
| K181745 — FUJIFILM Duodenoscope Model | Fujifilm Corporation Mar 28, 2019 |
| K183105 — Mimics Medical | Materialise NV Mar 27, 2019 |
| K182821 — Accutorr 7/VS-900/VS-900c Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 27, 2019 |
| K183410 — AMSCO 600 Steam Sterilizer | STERIS Corporation Mar 27, 2019 |
| K190242 — Tyto Thermometer | Tyto Care , Ltd. Mar 27, 2019 |
| K190302 — 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 | Centers For Disease Control And Prevention Mar 27, 2019 |
| K182835 — WOLF Thrombectomy Device | 880 Medical, LLC Mar 27, 2019 |
| K190446 — Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC Mar 27, 2019 |
| K182738 — 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) | Hangzhou AllTest Biotech Co., Ltd. Mar 27, 2019 |
| K181929 — MiMo(TM) Negative Pressure Wound Therapy System | Baymax Research, Inc. Mar 27, 2019 |
| K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. Mar 27, 2019 |
| K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated Mar 27, 2019 |
| K181882 — eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. Mar 27, 2019 |
| K190073 — Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | Current Health , Ltd. Mar 27, 2019 |
| K190232 — Synapse PACS | Fujifilm Corporation Mar 26, 2019 |
| K181858 — Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH Mar 26, 2019 |
| K183628 — Arthrex TensionLoc System | Arthrex, Inc. Mar 26, 2019 |
| K183154 — SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited Mar 26, 2019 |
| K182897 — Velano Vascular Q2 Extension Set | Velano Vascular Mar 26, 2019 |
| K190392 — WaveLight FS200 Patient Interface | Alcon Laboratories, Inc. Mar 26, 2019 |
| K190404 — OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. Mar 26, 2019 |
| K181817 — transGlideXT Expandable Introducer | Transaortic Medical, Inc. Mar 26, 2019 |
| K182947 — Dental Pain Eraser | Synapse Dental, LLC Mar 26, 2019 |
| K181658 — MobileECG 2 BT | Memtec Corporation Mar 26, 2019 |
| K181716 — InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health Mar 25, 2019 |
| K181905 — AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation Mar 25, 2019 |
| K181778 — MUTARS Proximal Femur Replacement System | Implantcast GmbH Mar 25, 2019 |
| K190015 — Ballancer Gold, 1212 | Mego Afek AC , Ltd. Mar 25, 2019 |
| K190093 — Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) Mar 25, 2019 |
| K183491 — Arm Blood Pressure Monitor | Xuzhou Yongkang Electronic Science Technology Co., Ltd. Mar 24, 2019 |
| K190430 — OsteoCentric Bone Plate and Screw System | Osteocentric Trauma Mar 22, 2019 |
| K183164 — uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. Mar 22, 2019 |
| K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC Mar 22, 2019 |
| K183353 — Telescope Guide Extension Catheter | Medtronic, Inc. Mar 22, 2019 |
| K181959 — HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. Mar 22, 2019 |
| K182887 — Masimo Rad-67 Pulse CO-Oximeter and Accessories | Masimo Corporation Mar 22, 2019 |
| K182395 — OARtrac System | Radialdyne, LLC Mar 22, 2019 |
| K181360 — ON-Q* Pump with Bolus | Halyard Health Mar 22, 2019 |
| K190252 — MTS Gentamicin 0.016 - 256 µg/mL | Liofilchem S.R.L. Mar 22, 2019 |
| K182554 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | He Chuang Plastic & Rubber Co., Ltd. Mar 22, 2019 |
| K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube | Covidien Mar 22, 2019 |
| K182186 — CMOS Video-Rhino-Laryngoscope System | KARL STORZ Endoscopy-America, Inc. Mar 22, 2019 |
| K181173 — ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated Mar 22, 2019 |
| K181722 — Polyethylene Catheter | Cook Incorporated Mar 22, 2019 |