| K183607 — FUJIFILM Bronchoscope | Fujifilm Corporation Aug 23, 2019 |
| K192047 — Rampart One Lumbar Interbody Fusion System | Spineology, Inc. Aug 23, 2019 |
| K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. Aug 23, 2019 |
| K191180 — Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. Aug 23, 2019 |
| K191809 — MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | Liofilchem S.R.L. Aug 23, 2019 |
| K191119 — EkoSonic Endovascular Device | Btg International, Inc. Aug 23, 2019 |
| K190459 — Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC Aug 23, 2019 |
| K190127 — Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC Aug 23, 2019 |
| K191412 — VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH Aug 23, 2019 |
| K191130 — Customized Contour Implant | Implantech Associates, Inc. Aug 23, 2019 |
| K183684 — Libertas Taper Uncemented Femoral Stem | Maxx Orthopedics, Inc. Aug 23, 2019 |
| K182950 — Acare Suction Unit | Acare Technology Co., Ltd. Aug 23, 2019 |
| K191063 — 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. Aug 23, 2019 |
| K183567 — Vyntus/SentrySuite Product Line | Vyaire Medical Aug 23, 2019 |
| K191990 — OSW Aligner System | Osw Manufacturing, LLC Aug 23, 2019 |
| K192021 — NCB Polyaxial Locking Plate System | Zimmer GmbH Aug 22, 2019 |
| K181888 — Osstell Beacon | Osstell AB Aug 22, 2019 |
| K190126 — Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. Aug 22, 2019 |
| K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | Biomerieux S.A. Aug 22, 2019 |
| K190792 — BB-613WP | Biobeat Technologies , Ltd. Aug 22, 2019 |
| K191242 — HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL Aug 22, 2019 |
| K190402 — Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) Aug 22, 2019 |
| K191393 — INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc Aug 22, 2019 |
| K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | STERIS Corporation Aug 21, 2019 |
| K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. Aug 21, 2019 |
| K190026 — Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Teleflex Medical Aug 21, 2019 |
| K190044 — VSP Orthopedics System | 3D Systems, Inc. Aug 21, 2019 |
| K191948 — GlideScope BFlex 5.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc Aug 21, 2019 |
| K191623 — ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. Aug 21, 2019 |
| K183390 — QNext and DG-PT | Diagnostic Grifols, S.A. Aug 21, 2019 |
| K191561 — Exactech Equinoxe Humeral Augmented Trays | Exactech, Inc. Aug 20, 2019 |
| K191936 — iNSitu Total Hip System | Thecken Companies, LLC Aug 20, 2019 |
| K182086 — ARCO FP | A.T.S. Applicazione Tecnologie Speciali S.R.L. Aug 20, 2019 |
| K183356 — Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. Aug 19, 2019 |
| K191985 — Optilite IgA Kit | The Binding Site Group , Ltd. Aug 19, 2019 |
| K191342 — CrossRoads Screw System | Crossroads Extemity Systems, LLC Aug 19, 2019 |
| K190207 — Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. Aug 19, 2019 |
| K191339 — Zavation eZspand Interbody System | Zavation Medical Products, LLC Aug 19, 2019 |
| K190988 — GIM-STIM OTC TENS/EMS System | Gemore Technology Co, Ltd. Aug 16, 2019 |
| K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics Aug 16, 2019 |
| K191609 — Tria Soft Ureteral Stent | Boston Scientific Corporation Aug 16, 2019 |
| K191626 — Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation Aug 16, 2019 |
| K191349 — 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. Aug 16, 2019 |
| K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A Aug 16, 2019 |
| K183536 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega NGC Sdn. Bhd. Aug 16, 2019 |
| K191924 — SAFECARE® THC Urine Strip Test | Safecare Biotech (Hangzhou) Co., Ltd. Aug 16, 2019 |
| K191504 — PowerDR | Radiology Information Systems, Inc. Aug 16, 2019 |
| K191636 — APTUS Foot System | Medartis AG Aug 16, 2019 |
| K190735 — EQ Balance | Upright Science, Inc. Aug 16, 2019 |
| K183108 — Combined Aerobika OPEP and VersaPAP device | Trudell Medical International Aug 16, 2019 |