| VariAx 2 System, VariAx 2 Mini Fragment System (K191412) | Stryker GmbH | 2019-08-23 |
| Hemoflow F3 and F4 Dialyzers (K190459) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| EkoSonic Endovascular Device (K191119) | Btg International, Inc. | 2019-08-23 |
| Customized Contour Implant (K191130) | Implantech Associates, Inc. | 2019-08-23 |
| CrossBay Cervical Dilator Catheter System (K190813) | Crossbay Medical | 2019-08-23 |
| Libertas – Taper Uncemented Femoral Stem (K183684) | Maxx Orthopedics, Inc. | 2019-08-23 |
| REMEDY Acetabular Cup (K191981) | Osteoremedies, LLC | 2019-08-23 |
| Rampart™ One Lumbar Interbody Fusion System (K192047) | Spineology, Inc. | 2019-08-23 |
| Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (K190593) | iRhythm Technologies, Inc. | 2019-08-23 |
| Acare Suction Unit (K182950) | Acare Technology Co., Ltd. | 2019-08-23 |
| MTS Imipenem-relebactam 0.002/4-32/4 µg/mL (K191809) | Liofilchem s.r.l. | 2019-08-23 |
| Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter (K190127) | Innovative Health, LLC | 2019-08-23 |
| Vyntus/SentrySuite Product Line (K183567) | Vyaire Medical | 2019-08-23 |
| Efficient Care 3D Planning (K183544) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-23 |
| Electronic Blood Pressure Monitor (K191180) | Shenzhen AOJ Medical Technology Co., Ltd. | 2019-08-23 |
| BB-613WP (K190792) | Biobeat Technologies , Ltd. | 2019-08-22 |
| INFINITY Total Ankle System, INBONE Total Ankle System (K191393) | Wrightmedicaltechnologyinc | 2019-08-22 |
| HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242) | Medos International SARL | 2019-08-22 |
| Bendit2.7 Steerable Microcatheter (K190126) | Bend IT Technologies, Ltd. | 2019-08-22 |
| Osstell Beacon (K181888) | Osstell AB | 2019-08-22 |
| Triathlon Total Knee System-Additional Components (K190402) | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019-08-22 |
| ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (K191953) | Biomerieux S.A. | 2019-08-22 |
| NCB Polyaxial Locking Plate System (K192021) | Zimmer GmbH | 2019-08-22 |
| RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K190081) | STERIS Corporation | 2019-08-21 |
| ScanX Touch/ScanX Duo Touch (K191623) | Air Techniques, Inc. | 2019-08-21 |
| VSP Orthopedics System (K190044) | 3D Systems, Inc. | 2019-08-21 |
| QNext and DG-PT (K183390) | Diagnostic Grifols, S.A. | 2019-08-21 |
| Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) (K190026) | Teleflex Medical | 2019-08-21 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413) | AtriCure, Inc. | 2019-08-21 |
| GlideScope BFlex 5.8 Single-Use Bronchoscope (K191948) | Verathon Medical (Canada) Ulc | 2019-08-21 |
| ARCO FP (K182086) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2019-08-20 |
| Exactech Equinoxe Humeral Augmented Trays (K191561) | Exactech, Inc. | 2019-08-20 |
| iNSitu Total Hip System (K191936) | Thecken Companies, LLC | 2019-08-20 |
| CrossRoads Screw System (K191342) | Crossroads Extemity Systems, LLC | 2019-08-19 |
| Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K183356) | Weihai Xingtai Packaging Products Co., Ltd. | 2019-08-19 |
| Zavation eZspand Interbody System (K191339) | Zavation Medical Products, LLC | 2019-08-19 |
| Optilite IgA Kit (K191985) | The Binding Site Group , Ltd. | 2019-08-19 |
| Blood Pressure Monitor (K190207) | Shenzhen Viatom Technology Co., Ltd. | 2019-08-19 |
| SAFECARE® THC Urine Strip Test (K191924) | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191626) | Nova Biomedical Corporation | 2019-08-16 |
| Piezon Built-in Kit, Piezon Built-in Kit LED (K191079) | E.M.S Electro Medical Systems S.A | 2019-08-16 |
| APTUS Foot System (K191636) | Medartis AG | 2019-08-16 |
| SKR 4000 (K191645) | Konica Minolta, Inc. | 2019-08-16 |
| Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899) | Roche Diagnostics | 2019-08-16 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |
| EQ Balance (K190735) | Upright Science, Inc. | 2019-08-16 |
| Vyntus BODY (K190853) | Vyaire Medical, Inc. | 2019-08-16 |
| Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (K192018) | Titan Spine, Inc. | 2019-08-16 |
| Combined Aerobika OPEP and VersaPAP device (K183108) | Trudell Medical International | 2019-08-16 |
| Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K183536) | Hartalega NGC Sdn. Bhd. | 2019-08-16 |
| GIM-STIM OTC TENS/EMS System (K190988) | Gemore Technology Co, Ltd. | 2019-08-16 |
| 980nm Diode Laser Therapy Device (K191349) | Shanghai Apolo Medical Technology Co., Ltd. | 2019-08-16 |
| TriMAX Implant System (K190722) | Crossroads Extemity Systems, LLC | 2019-08-16 |
| Tria Soft Ureteral Stent (K191609) | Boston Scientific Corporation | 2019-08-16 |
| PowerDR (K191504) | Radiology Information Systems, Inc. | 2019-08-16 |
| Suprasorb A + Ag “R” (K183208) | Speciality Fibres and Materials, Ltd. | 2019-08-15 |
| TULSA-PRO System (K191200) | Profound Medical, Inc. | 2019-08-15 |
| Stryker CMF MEDPOR Priority Customized Implant Kit (K191916) | Stryker Leibinger GmbH & Co KG | 2019-08-15 |
| ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (K191621) | Choice Spine, LLC | 2019-08-15 |
| ACUSON P200 Diagnostic Ultrasound System (K191922) | Siemens Medical Solutions USA, Inc. | 2019-08-15 |
| Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K190610) | Sterilmed, Inc. | 2019-08-15 |
| Biovitals Analytics Engine (K183282) | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| HeartFlow FFRct Analysis (K190925) | HeartFlow, Inc. | 2019-08-15 |
| HCT Empty EVA Container Pack (K190328) | Health Care Technologies | 2019-08-15 |
| Viola (K190264) | Meditime Co., Ltd. | 2019-08-15 |
| OneDraw A1C Test System (K183230) | Drawbridge Health, Inc. | 2019-08-15 |
| Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment (K190991) | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2019-08-15 |
| SleepImage System (K182618) | Mycardio, LLC Dba Sleepimage. | 2019-08-14 |
| AutoStrut (K191241) | Orthospin | 2019-08-14 |
| IS-III active System_S-narrow Type (K190849) | Neobiotech Co., Ltd. | 2019-08-14 |
| Servator C SALF Solution (K190063) | S.A.L.F. Spa | 2019-08-14 |
| NuVaisve® Reline® Cervical System (K191553) | Nu Vasive, Incorporated | 2019-08-14 |
| BOSS Toe Fixation System (K190261) | Arthrosurface, Inc. | 2019-08-14 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| SignalMark Breast Marker (K190689) | View Point Medical, Inc. | 2019-08-14 |
| Instylla Microcatheter (K191731) | Instylla, Inc. | 2019-08-13 |
| PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970) | Wrightmedicaltechnologyinc | 2019-08-13 |
| Modular Power Standing System (K191376) | Motion Concepts | 2019-08-13 |
| Cartesion Prime (K191582) | Canon Medical Systems Corporation | 2019-08-13 |
| xPORT Lens Fragmentation System (K191024) | Carl Zeiss Meditec Cataract Technology, Inc. | 2019-08-13 |
| Elecsys Anti-HAV II (K190428) | Roche Diagnostics | 2019-08-13 |
| Blue Sky Bio Zygomatic Implant System (K190491) | Blue Sky Bio, LLC | 2019-08-12 |
| Facilis™ Spinal System (K191494) | Baui Biotech Co., Ltd. | 2019-08-12 |
| EVOL® -SI Joint Fusion System (K190025) | Cutting Edge Spine, LLC | 2019-08-12 |
| ATEC Lateral Interbody System (K191311) | Alphatec Spine, Inc. | 2019-08-12 |
| Dr J Spinal and Epidural Needles (K183316) | Dr. Japan Co., Ltd. | 2019-08-12 |
| Arsenal Plating System (K191009) | Trilliant Surgical | 2019-08-12 |
| Critical Care Suite (K183182) | Ge Medical Systems, LLC | 2019-08-12 |
| Cervical Spinal Truss System-Stand Alone (CSTS-SA) (K190870) | 4Web, Inc. | 2019-08-12 |
| Versana Balance (K191792) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 |
| Morpheus-C (K190371) | Biogennix, LLC | 2019-08-09 |
| Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter (K191560) | Vascular Solutions, LLC | 2019-08-09 |
| NxStage Cartridge Express with Speedswap (K183158) | Nxstage Medical, Inc. | 2019-08-09 |
| ELAN 4 Tools (K183203) | Aesculap, Inc. | 2019-08-09 |
| SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (K183647) | Olympus Surgical Technologies America | 2019-08-09 |
| Bone Screw, Bone Tack (K182881) | Osstem Implant Co., Ltd. | 2019-08-09 |
| Versana Active (K191798) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 |
| DR 100s (K191884) | Agfa N.V. | 2019-08-09 |
| ARIETTA 750 (K191233) | Hitachi Healthcare Americas | 2019-08-09 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (K191114) | Avenu Medical | 2019-08-09 |