| Fidmi Low Profile Enteral Feeding Device (K191844) | Fidmi Medical, Ltd. | 2019-09-30 |
| Visalys Tooth Primer (K191524) | Kettenbach GmbH & Co. KG | 2019-09-29 |
| Sorrento Bone Graft Substitute (K191074) | Xenco Medical, LLC | 2019-09-27 |
| MiniMAX (K192352) | Medacta International S.A. | 2019-09-27 |
| ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (K192050) | Biomerieux S.A. | 2019-09-27 |
| XLR8 Abdominal Wound Dressing Kit (K182722) | Genadyne Biotechnologies | 2019-09-27 |
| FUJIFILM Duodenoscope Model ED-580XT (K191747) | Fujifilm Corporation | 2019-09-27 |
| Precision Spine Navigation Instrumentation (K181606) | Precision Spine, Inc. | 2019-09-27 |
| CATSmart (K192368) | Fresenius Kabi AG | 2019-09-27 |
| Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076) | Cepheid | 2019-09-27 |
| CEREC Guides (K190059) | Dentsply Sirona | 2019-09-27 |
| Radiance 330 Proton Beam Therapy System (K191521) | Protom International Holding Corporation | 2019-09-27 |
| Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (K191444) | Medtronic, Inc. | 2019-09-27 |
| ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (K192129) | Clearlab SG Pte, Ltd. | 2019-09-27 |
| EpiFaith Syringe (K192421) | Flat Medical Co., Ltd. | 2019-09-27 |
| Smart-C (K190024) | Turner Imaging Systems, Inc. | 2019-09-27 |
| Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (K180001) | Embla Systems | 2019-09-27 |
| FlexBand Plus (K192112) | International Life Sciences | 2019-09-27 |
| Dia-Proseal (K182009) | DiaDent Group International | 2019-09-26 |
| PRECICE System (K191336) | Nuvasive Specialized Orthopedics, Inc. | 2019-09-26 |
| eCarbon IBDs (K191537) | Back 2 Basics Direct, LLC | 2019-09-26 |
| SepaSperm Washing Solution, SepaSperm Solution (K190199) | Kitazato Corporation | 2019-09-26 |
| NuVasive NuvaLine (K192435) | Nu Vasive, Incorporated | 2019-09-26 |
| GXR-Series Diagnostic X-Ray System (K192364) | DRGEM Corporation | 2019-09-26 |
| Sterile Dilator (K192195) | Galt Medical Corp. | 2019-09-26 |
| BioZorb SP Marker (K192371) | Focal Therapeutics | 2019-09-26 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff (K190454) | Hartalega NGC Sdn. Bhd. | 2019-09-26 |
| Exogenesis Hernia Mesh (K191545) | Exogenesis Corporation | 2019-09-26 |
| Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (K190029) | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2019-09-26 |
| PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate (K190466) | Shen Wei USA, Inc. | 2019-09-26 |
| Spectralis HRA+OCT and Variants (K192391) | Heidelberg Engineering GmbH | 2019-09-26 |
| StoneChecker (K191530) | Imaging Biometrics, LLC | 2019-09-26 |
| Genesys Spine Sacroiliac Joint Fusion System (K191748) | Genesys Spine | 2019-09-26 |
| ARIES MRSA Assay (K191742) | Luminex Corporation | 2019-09-25 |
| EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (K190875) | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019-09-25 |
| PhoeniX (K192011) | Sedecal., Sa. | 2019-09-25 |
| TranS1 Interbody Fusion System (K191791) | Trans1 | 2019-09-25 |
| SafeBreath Filter Mouthpiece (K190022) | MD Diagnostics Limited | 2019-09-25 |
| OMNI TiN Coated Apex Knee™ System (K191765) | Omni Life Science, Inc. | 2019-09-25 |
| NuStat (K183190) | Beeken Biomedical, LLC | 2019-09-25 |
| Thermoplastic Masks (K192102) | Aktina Medical Corporation | 2019-09-25 |
| Aloe Glide Lubricant (K190323) | Desert Harvest, Inc. | 2019-09-25 |
| LifeWindow LW8 Lite (K183687) | Digicare Biomedical Technology, Inc. | 2019-09-25 |
| Mediracer NCS (K190536) | Mediracer OY | 2019-09-25 |
| 3D Visualization System (K183675) | Scivita Medical Technology Co., Ltd. | 2019-09-25 |
| CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (K191212) | Medos International SARL | 2019-09-24 |
| Novidia Universal Bond (K183391) | Nobio , Ltd. | 2019-09-24 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| SmoothSkin BARE+ (K192010) | Cyden Limited | 2019-09-24 |
| EasiSlush (K191006) | Bridge TO Life, Ltd. | 2019-09-24 |
| Mako Total Hip Application, Mako Total Knee Application (K191998) | Mako Surgical Corp. | 2019-09-24 |
| Innovasis Gibralt Spine System (K192354) | Innovasis, Inc. | 2019-09-24 |
| Buhlmann fCAL turbo and CALEX Cap (K191718) | Buhlmann Laboratories AG | 2019-09-24 |
| USTAR II System (K190100) | United Orthopedic Corporation | 2019-09-23 |
| SPIRA Open Matrix ALIF and LLIF (K190483) | Camber Spine Technologies | 2019-09-23 |
| T-Stat 2.0 Microvascular Tissue Oximeter (K192322) | Spectros Corporation | 2019-09-23 |
| Medi-Direct TENS Pen (K182671) | Jkh USA, LLC | 2019-09-21 |
| ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath (K192332) | Inari Medical | 2019-09-20 |
| SeeFactorCT3 (K190856) | Epica International, Inc. | 2019-09-20 |
| Merge Cardio (K192276) | Merge Healthcare Incorporated | 2019-09-20 |
| CivaDerm (K191324) | Civatech Oncology, Inc. | 2019-09-20 |
| Omnipod DASH Insulin Management System with interoperable technology (K191679) | Insulet Corporation | 2019-09-20 |
| Philips IntelliSite Pathology Solution (K192259) | Philips Electronics Nederland B.V. | 2019-09-20 |
| INTAI Surgery Navigation System (K180523) | Intai Technology Corporation | 2019-09-20 |
| Medtronic 6F Taiga Guiding Catheter (K192296) | Medtronic Vascular | 2019-09-20 |
| Supercath 5 (K190001) | Togo Medikit Co., Ltd. | 2019-09-20 |
| BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (K192301) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 |
| Hinged Laminoplasty System (K191927) | Life Spine, Inc. | 2019-09-20 |
| Clyra Wound Irrigation Solution (K181428) | Clyra Medical Technologies, Inc. | 2019-09-20 |
| syngo.CT Extended Functionality (K192402) | Siemens Medical Solutions USA, Inc. | 2019-09-20 |
| High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526) | CarboFix Orthopedics , Ltd. | 2019-09-19 |
| GEHC DXA Bone Densitometers with enCORE version 18 (K191112) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 |
| SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) (K182631) | Eurogreen International, Inc. | 2019-09-19 |
| Sapphire NC Plus Coronary Dilatation Catheter (K192344) | Orbusneich Medical Trading, Inc. | 2019-09-19 |
| ProPerformance Recovery System (K192252) | Menlo Brands, LLC | 2019-09-19 |
| RS80 EVO Diagnostic Ultrasound System (K192030) | Samsung Medison Co., Ltd. | 2019-09-19 |
| HardyDisk AST Lefamulin 20µg (LMU20) (K192326) | Hardy Diagnostics | 2019-09-19 |
| Dornier MINNOW Ureteral Catheter (K191187) | Dornier Medtech America, Inc. | 2019-09-18 |
| Syngo.Via RT Image Suite (K192065) | Siemens Medical Solutions USA, Inc. | 2019-09-18 |
| Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663) | Canon Medical Systems Corporation | 2019-09-18 |
| EMS Belt (Model MC0485) (K183103) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | 2019-09-18 |
| VORTRAN APM-Plus (K182292) | Vortran Medical Technology 1, Inc. | 2019-09-18 |
| AccuCath Ace Intravascular Catheter (K191232) | C.R. Bard, Inc. | 2019-09-18 |
| Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant (K190858) | United Consortium | 2019-09-18 |
| geko T-2 and geko T-3 Neuromuscular Stimulators (K191113) | Firstkind Limited | 2019-09-18 |
| GM501 Mineral Oil (K191552) | Hamilton Thorne, Inc. | 2019-09-18 |
| BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (K191457) | Med-El Elektromedizinische Geraete GmbH | 2019-09-18 |
| HEDRON Lumbar Spacers (K191391) | Globus Medical, Inc. | 2019-09-18 |
| InnoSight Diagnostic Ultrasound System (K192254) | Qisda Corporation | 2019-09-18 |
| OraCure (K183436) | Tbm Corporation | 2019-09-18 |
| 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage (K190563) | Solco Biomedical Co., Ltd. | 2019-09-18 |
| Flexible HD Cysto-Urethroscope System (K191357) | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 |
| Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) (K190308) | Amd Medicom, Inc. | 2019-09-17 |
| Sapphire Dorsal Comfort Fit (K181416) | Crane Dental Laboratory, Inc. | 2019-09-17 |
| VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord (K191947) | Maquet Cardiovascular, LLC | 2019-09-17 |
| UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K191929) | Unicon Optical Co., Ltd. | 2019-09-17 |
| iNSitu Bipolar Hip System (K191297) | Theken Companies, LLC | 2019-09-17 |
| Bio Guard Air/Water & Suction Valves (K192059) | United States Endoscopy Group, Inc. | 2019-09-17 |
| Poly Clear (K183708) | Medtek Skincare, LLC | 2019-09-17 |
| HEDRON Cervical Spacers (K191243) | Globus Medical, Inc. | 2019-09-17 |