| DePuy Corail AMT Hip Prosthesis (K192946) | DePuy Orthopaedics, Inc. | 2019-11-26 |
| Pinnacle Duofix HA Acetabular Cup Prosthesis (K192919) | DePuy Orthopaedics, Inc. | 2019-11-26 |
| ETEST Delafloxacin (DFX) (0.002-32 µg/mL) (K192738) | Biomerieux S.A. | 2019-11-26 |
| Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (K192376) | Diasorin Molecular, LLC | 2019-11-26 |
| OrthoGold (K191961) | Tissue Regeneration Technologies | 2019-11-26 |
| Heraeus Peripheral Guidewire (K191502) | Heraeus Medical Components, LLC | 2019-11-26 |
| Ion Endoluminal System (K192367) | Intuitive Surgical, Inc. | 2019-11-26 |
| FiberTak Button (K191426) | Arthrex, Inc. | 2019-11-26 |
| Physica KR Liner and SMR Reverse Humeral Liner (K190911) | Limacorporate | 2019-11-26 |
| ARIX Cannulated Screw System (K192417) | Jeil Medical Corporation | 2019-11-26 |
| SOZO (K190529) | ImpediMed Limited | 2019-11-25 |
| Cortina™ [MAX] Lumbar Cage System (K192248) | Neurostructures, Inc. | 2019-11-25 |
| VS3-IR (K191851) | Medtronic | 2019-11-25 |
| Pivot System Sterilization case (K181845) | Rp Medical, Inc. | 2019-11-25 |
| Infant Incubator (K190494) | Ningbo David Medical Device Co., Ltd. | 2019-11-25 |
| Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) (K190590) | Allwin Medical Devices, Inc. | 2019-11-25 |
| ADVIA Centaur Cortisol (COR) (K192788) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 |
| Blue Latex Examination Powder Free Gloves (K192329) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019-11-25 |
| Cadwell Bolt Software (K190760) | Cadwell Industries, Inc. | 2019-11-23 |
| DEXIS CariVu 3-in-1 by KaVo (K182712) | Kaltenbach & Voigt GmbH | 2019-11-23 |
| 6450 Ultrasound system (K192157) | Esaote, S.p.A. | 2019-11-22 |
| Parkell Desensitizer Gel (K191103) | Parkell, Inc. | 2019-11-22 |
| EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP (K193017) | DRTECH Corporation | 2019-11-22 |
| KLS Martin Individual Patient Solutions (K191028) | KLS-Martin L.P. | 2019-11-22 |
| Color Liquid, Vita Liquid (K190518) | Zirkonzahn Srl | 2019-11-22 |
| Healy (K191075) | Timewaver Production GmbH | 2019-11-22 |
| C2 CryoBalloon EndoGrip (K193036) | Pentax Medical, A Division of Pentax of America, Inc. | 2019-11-22 |
| Trevo Trak 21 Microcatheter (K192122) | Stryker | 2019-11-22 |
| Senhance Surgical System (K192877) | Transenterix, Inc. | 2019-11-22 |
| VariAx Foot (K192675) | Stryker GmbH | 2019-11-22 |
| Navina Smart System, Navina Classic System (K190977) | Dentsply Sirona | 2019-11-22 |
| Hair Growth System (K191754) | Kunshan Bella Optical Technology Co., Ltd. | 2019-11-22 |
| Synergy Platform, Synergy, Infinity, VersaHD (K192242) | Elekta Limited | 2019-11-22 |
| Parcus Synd-EZ SS (K192964) | Parcus Medical, LLC | 2019-11-22 |
| INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream (K192843) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2019-11-22 |
| MatriStem UBM Pericardial Patch (K191734) | Acell, Inc. | 2019-11-22 |
| PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) (K190697) | Kci USA, Inc. | 2019-11-22 |
| Trevo NXT ProVue Retriever (K192207) | Stryker | 2019-11-22 |
| Revitalair 430F (K171899) | Oxavita Srl | 2019-11-22 |
| SMR TT Augmented Glenoid System (K191746) | Lima Corporate S.P.A. | 2019-11-22 |
| SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512) | Intelligent Endoscopy | 2019-11-22 |
| 3M™ Attest™ Steam Chemical Integrators (K191236) | 3M Company | 2019-11-22 |
| BruxZir GT (Gum Tissue) Color (K191903) | Prismatik Dentalcraft, Inc. | 2019-11-22 |
| Applied Medical Laparoscopic Linear Cutter (K190331) | Applied Medical Resources Corporation | 2019-11-22 |
| AMIStem-P Short Neck (K192126) | Medacta International S.A. | 2019-11-22 |
| Medsynapse Ris Pacs & Medsynapse VNA (K192508) | Medsynaptic Private, Ltd. | 2019-11-22 |
| LEva Pelvic Digital Health System (K192270) | Renovia, Inc. | 2019-11-22 |
| Spes Medica Subdermal Needle Electrodes (K192603) | Spes Medica Srl | 2019-11-22 |
| everX Flow (K192260) | GC America, Inc. | 2019-11-22 |
| Navigated Anterolateral Disc Prep Instruments (K192336) | Medtronic Sofamor Danek USA, Inc. | 2019-11-22 |
| ADVIA Centaur CA 15-3 assay (K192777) | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 |
| Hemochron Signature Elite (K193041) | Accriva Diagnostics, Inc. | 2019-11-22 |
| EXPD 4343P, EXPD 3643P (K193031) | DRTECH Corporation | 2019-11-22 |
| LZI Cotinine II Enzyme Immunoassay (K192299) | Lin-Zhi International, Inc. | 2019-11-21 |
| Axis Plating System (K192592) | Extremity Medical, LLC | 2019-11-21 |
| SAM IO Intraosseous Access System (K191488) | Sam® Medical Products, Inc. | 2019-11-21 |
| M. Blue Adjustable Shunt System (K192266) | Aesculap, Inc. | 2019-11-21 |
| Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories (K192124) | Us Medical Innovations, LLC | 2019-11-21 |
| Asahi PTCA Guide Wire Asahi SION Series (K191464) | Asahi Intecc Co., Ltd. | 2019-11-21 |
| Torpedo Gelatin Foam (K192480) | Biosphere Medical, S.A. | 2019-11-21 |
| Engage™ Partial Knee System (K190439) | Engage Uni, LLC | 2019-11-21 |
| CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839) | Oralabs, Inc. | 2019-11-21 |
| SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO (K192061) | Siemens Medical Solutions USA, Inc. | 2019-11-21 |
| PG Pro Microcatheter (K192625) | MicroVention, Inc. A TERUMO Group Company | 2019-11-21 |
| Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool (K192996) | Biotronik, Inc. | 2019-11-21 |
| FUJIFILM Endoscope Model EC-760Z-V/L (K192664) | Fujifilm Corporation | 2019-11-20 |
| SmartLite Pro Modular LED Curing Light (K191865) | Dentsply Sirona | 2019-11-20 |
| Penumbra LP Coil System (K192955) | Penumbra, Inc. | 2019-11-20 |
| AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (K192281) | Medos International SARL | 2019-11-20 |
| TranS1 AxiaLIF Plus System (K192792) | Trans1 | 2019-11-20 |
| SDS1.2 dental implant (K181953) | Sds Swiss Dental Solutions AG | 2019-11-20 |
| Ziehm 8000 (K190497) | Ziehm Imaging GmbH | 2019-11-20 |
| uPMR 790 (K192672) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 |
| EchoTip Insight Portosystemic Pressure Gradient Measuring System (DEN180062) | Cook Ireland, Ltd. | 2019-11-20 |
| Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, (K192204) | Valencia Naturals, Inc. | 2019-11-19 |
| IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 (K182979) | Philips Medizin Systeme Boeblingen GmbH | 2019-11-19 |
| RSI-MRI+ (K191278) | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019-11-19 |
| Dannik Laparoscopic Suction Irrigation System (K192643) | Dannik | 2019-11-19 |
| L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable (K192292) | Stryker | 2019-11-19 |
| Vial Adapter Ø20 mm , Vial Adapter Ø13 mm (K190816) | Avenir Performance Europeenne Medical (Apem) | 2019-11-19 |
| TwinScan 808/755 Laser System (K192269) | Gme German Medical Engineering GmbH | 2019-11-19 |
| Dolphin Medical Imaging USB Ultrasound System (K192573) | Dolphin Medical Imaging, LLC | 2019-11-19 |
| Digital Thermometer (K183393) | Joytech Healthcare Co. , Ltd. | 2019-11-18 |
| JTL-250-01 (K182732) | Jointechlabs, Inc. | 2019-11-18 |
| FluoroCal (K182917) | Bisco, Inc. | 2019-11-18 |
| CLEARFIL MAJESTY ES Flow (K191980) | Kuraray Noritake Dental, Inc. | 2019-11-18 |
| Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) (K190797) | Reed Medical (Zhejiang) Co., Ltd. | 2019-11-18 |
| Impella CP Introducer (K192769) | Abiomed, Inc. | 2019-11-18 |
| PolyLock Small Bone Plating System (K192323) | Fusion Orthopedics, LLC | 2019-11-18 |
| 3M Comply Hydrogen Peroxide Chemical Indicator (K192937) | 3M Company | 2019-11-16 |
| ROSA Bracket (K182672) | Gni Co., Ltd. | 2019-11-15 |
| CoolTone (K192940) | Zimmer Medizinsysteme GmbH | 2019-11-15 |
| Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397) | Immunalysis Corporation | 2019-11-15 |
| Gabriel Feeding Tube with Balloon, and EnFit Connector (K191784) | Syncro Medical Innovations, Inc. | 2019-11-15 |
| KeyPrint KeySplint Soft (K183598) | Keystone Industries | 2019-11-15 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K192174) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-11-15 |
| Arcus Head Fixation Frame (K191701) | Mri Interventions, Inc. | 2019-11-15 |
| DRSplus (K192113) | Centervue S.P.A. | 2019-11-15 |
| TDM Plate and Screw Systems (K190391) | Tdm Co., Ltd. | 2019-11-15 |
| CAPERE Thrombectomy System (K192935) | Vascular Medcure, Inc. | 2019-11-15 |