| GammaTile (K190296) | Gt Medical Technologies | 2019-03-13 |
| FasTouch Absorbable Fixation System (K181668) | Via Surgical , Ltd. | 2019-03-13 |
| Quantra Hemostasis Analyzer, QPlus Cartridge (DEN180017) | Hemosonics, LLC | 2019-03-12 |
| ISS-JAZZ Screw System and JAZZ CAP SP (K182771) | Implanet, S.A. | 2019-03-12 |
| BioPlex 2200 Lyme Total (K183446) | Bio-Rad Laboratories | 2019-03-12 |
| INnate Cannulated Screw System (K183603) | Exsomed Corporation | 2019-03-12 |
| ActivOrtho Nitinol Compression Screw System (K181610) | Activortho, Inc. | 2019-03-12 |
| Endotoxin Activity Assay (EAA) (K183176) | Spectral Medical, Inc. | 2019-03-12 |
| Microlife Digital Blood Pressure Monitor (K183469) | Microlife Intellectual Property GmbH | 2019-03-12 |
| Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces (K183610) | Bovie Medical Corporation | 2019-03-12 |
| CRYOcheck FVIII Inhibitor Kit (K183440) | Precision Biologic, Inc. | 2019-03-12 |
| Caiman 5 Maryland (K183180) | Aesculap, Inc. | 2019-03-12 |
| VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) (K183524) | bioMerieux, Inc. | 2019-03-12 |
| Double ENDOBUTTON Fixation Device (K183232) | Smith and Nephew, Inc. | 2019-03-12 |
| AirRay Subdural Cortical Electrodes (K183437) | Cortec GmbH | 2019-03-12 |
| Safety insulin needle for single use (K181447) | Berpu Medical Technology Co., Ltd. | 2019-03-12 |
| Rotium Bioresorbable Wick (K183236) | Nanofiber Solutions, LLC | 2019-03-11 |
| BoneTrust Implant System (K182313) | Medical Instinct Deutschland GmbH | 2019-03-11 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K182789) | KLS-Martin L.P. | 2019-03-11 |
| EasyInstruments (K182013) | Agency For Medical Innovations GmbH | 2019-03-11 |
| Inno-Pathwire (K182553) | Suzhou Innomed Medical Device Co., Ltd. | 2019-03-11 |
| EVOS Small Fragment Upper Extremity Plates Line Additions (K190253) | Smith & Nephew, Inc. | 2019-03-11 |
| Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs (K182241) | Sri Trang Gloves (Thailand) Co., Ltd. | 2019-03-11 |
| KardiaAI (K181823) | AliveCor, Inc. | 2019-03-11 |
| Kuros TLIF Cage (K183092) | Kuros Biosciences B.V | 2019-03-08 |
| RadiForce MX216 (K190153) | Eizo Corporation | 2019-03-08 |
| NewTom 5G XL (K183448) | Cefla S.C. | 2019-03-08 |
| Bariatric Power Positioning System (BPPS) (K182995) | Motion Concepts | 2019-03-08 |
| EchoSure Diagnostic Ultrasound System (K190039) | Sonavex, Inc. | 2019-03-08 |
| CoreDx™ Pulmonary Mini-Forceps (K183085) | Boston Scientific Corporation | 2019-03-08 |
| Provident II Hip Stem (K190276) | Stelkast, Inc. | 2019-03-08 |
| Nexus DR Digital X-ray Imaging System (K190146) | Varex Imaging Corporation | 2019-03-08 |
| Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads (K182799) | Arthrex, Inc. | 2019-03-08 |
| DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (K190206) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-08 |
| RADMAX Digital Imaging Software (K182537) | DRGEM Corporation | 2019-03-08 |
| Nitinol Thermocouple (TCN) Electrode (K183177) | Boston Scientific Corporation | 2019-03-08 |
| CORUS Spinal System (K190201) | Providence Medical Technology, Inc. | 2019-03-08 |
| ZAPnea Oral Appliance (K173064) | B. Fareid, Dds, PC | 2019-03-08 |
| cmTriage (K183285) | Curemetrix, Inc. | 2019-03-08 |
| Brainsway Deep TMS System (K183303) | Brainsway , Ltd. | 2019-03-08 |
| Medline Burn and Wound Dressing (OTC) (K190224) | Medline Industries, Inc. | 2019-03-08 |
| Rulo Radiofrequency Lesion Probe (K190256) | Epimed International, Inc. | 2019-03-08 |
| Cervella (K182311) | Innovative Neurological Devices, LLC | 2019-03-07 |
| iSLEEVE Introducer Set (K190184) | Boston Scientific | 2019-03-07 |
| HANAROSTENT LowAx Colon/Rectum (NNN) (K190141) | M.I.Tech Co., Ltd. | 2019-03-07 |
| DARI Health (K180880) | Scientific Analytics, Inc. | 2019-03-07 |
| VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) (K183551) | bioMerieux, Inc. | 2019-03-07 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| RhythmAnalytics (K182344) | Biofourmis Singapore Pte., Ltd. | 2019-03-07 |
| Spectrum Spine Expandable Cages (SSEC) (K173518) | Spectrum Spine, LLC | 2019-03-07 |
| Duo Lumbar Interbody Fusion Device (K190055) | Spineology, Inc. | 2019-03-07 |
| Bonebridge (K183373) | Med-El Elektromedizinische Geraete GmbH | 2019-03-07 |
| Endophys Pressure Sensing Sheath (K190098) | Endophys Holdings, LLC | 2019-03-07 |
| Introcan Safety 3 Closed IV Catheter (K182870) | B.Braun Medical, Inc. | 2019-03-07 |
| Electric Breast Pump (K182413) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2019-03-07 |
| VitalConnect Platform, VitalPatch Biosensor (K183078) | Vitalconnect, Inc. | 2019-03-07 |
| Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (K181807) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-03-06 |
| ChoiceSpine Stealth Cervical Spacer System (K183397) | Choicespine, LP | 2019-03-06 |
| Visualase Thermal Therapy System (K181859) | Medtronic Navigation, Inc. | 2019-03-06 |
| Joule System (K182173) | Sciton, Inc | 2019-03-06 |
| Hearing Healthcare Pro (K183201) | Db Diagnostic Systems, Inc. | 2019-03-06 |
| VISULAS green (K181682) | Carl Zeiss Meditec, AG | 2019-03-06 |
| PLANET Onco Dose (K182966) | Dosisoft | 2019-03-06 |
| ClearGrasp Snare (K183289) | Finemedix Co., Ltd. | 2019-03-06 |
| GenePOC Strep A (K183366) | Genepoc, Inc. | 2019-03-06 |
| ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) (K181656) | Eyemed Technologies S.R.L. | 2019-03-05 |
| Embrella Endoscopic Distal Attachment (K190030) | Micro-Tech (Nanjing) Co., Ltd. | 2019-03-05 |
| MAC Medical D-Series Blanket and Solution Warming Cabinets (K180842) | Mac Medical, Inc. | 2019-03-05 |
| Olympus Small Intestinal Capsule Endoscope System (K183053) | Olympus Medical Systems Corp. | 2019-03-05 |
| Imagio Ultrasound Imaging System (K182628) | Seno Medical Instruments, Inc. | 2019-03-05 |
| Stryker SternalPlate System (K183172) | Stryker | 2019-03-05 |
| MLP Special Locking Bone Plate System (K181843) | Maxxion Medical, LLC / Baumer SA | 2019-03-04 |
| SCARLET® AC-T Secured Anterior Cervical Cage (K190322) | Spineart | 2019-03-04 |
| JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (K183384) | United Consortium | 2019-03-04 |
| VS3-IR (K183453) | Medtronic | 2019-03-04 |
| Dimension Vista High-Sensitivity Troponin I (TNIH) Assay (K182225) | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 |
| SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices (K190193) | Spineex, Inc. | 2019-03-04 |
| Medline Reinforced Epidural Catheter (K181782) | Medline Industries, Inc. | 2019-03-04 |
| Electronic Blood Pressure Monitor (K182495) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019-03-03 |
| EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (K181871) | Phadia AB | 2019-03-01 |
| Vydence Laser Family (K190007) | Vydence Medical Industria E Comercio Ltda | 2019-03-01 |
| XactTrace Single Use Respiratory Effort Belt System (K173793) | Embla Systems | 2019-03-01 |
| Lead-free Chemical Indicators for Steam Sterilization (K181788) | Kem Medical Products Corp. | 2019-03-01 |
| Traditional Length GJ Feeding Device (K182804) | Applied Medical Technology, Inc. | 2019-03-01 |
| Polar Care Wave (K183702) | Breg, Inc. | 2019-03-01 |
| DxH 520 Hematology Instrument (K181475) | Beckman Coulter | 2019-03-01 |
| Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (K182822) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 |
| ClearON Mobile (K183478) | Rayence Co., Ltd. | 2019-03-01 |
| Tenodesis Screw System (K183690) | Paragon 28, Inc. | 2019-03-01 |
| Fetal Doppler, Model FD88 (K182710) | Shenzzhen Luckcome Technology Inc., Ltd. | 2019-03-01 |
| CurvaFix Intramedullary Rodscrew System (K180050) | Curvafix, Inc. | 2019-03-01 |
| BD Vacutainer Eclipse UltraFill Blood Collection Needle (K181730) | Becton, Dickinson and Company | 2019-03-01 |
| Early Bird Bleed Monitoring System (DEN180021) | Saranas, Inc. | 2019-03-01 |
| Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183401) | STERIS Corporation | 2019-03-01 |
| Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 |
| Idys™ TLIF TiVac (K183259) | Clariance, Sas | 2019-03-01 |
| ODI HD Dental Sensor (K190234) | Cnd Global Technologies, Inc. | 2019-03-01 |
| Manual Wheelchair (K180852) | Jiangyin Newrise Medical Equipment Co., Ltd. | 2019-03-01 |
| BrackFix (K183147) | Voco GmbH | 2019-03-01 |
| PRO-LITE Sterilization Tray (K183402) | STERIS Corporation | 2019-03-01 |