| Masimo Centroid System (K191882) | Masimo Corporation | 2020-04-22 |
| FAICO CMF System (K191997) | Faico Medical, LLC | 2020-04-22 |
| Acuson SC2000 Diagnostic Ultrasound System (K200585) | Siemens Medical Solutions USA, Inc. | 2020-04-22 |
| Infrared Forehead Thermometer (K190984) | Xiamen Ants Bro Technology Co., Ltd. | 2020-04-22 |
| Psychemedics Microplate EIA for Cotinine in Hair (K192517) | Psychemedics Corporation | 2020-04-22 |
| SYLFIRM X (K200185) | VIOL Co., Ltd. | 2020-04-22 |
| Indigo Aspiration System Lightning Aspiration Tubing (K200771) | Penumbra, Inc. | 2020-04-22 |
| Bevel Up Holder (K193074) | Nsp Tech Pte, Ltd. | 2020-04-21 |
| Lariat, Hot/Cold Snare (K200745) | United States Endoscopy Group, Inc. | 2020-04-21 |
| Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162) | Wuhan Greentek Pty , Ltd. | 2020-04-21 |
| Droplet Pen Needle 34G (K192082) | Htl-Strefa S.A | 2020-04-21 |
| Instylla Microcatheter (K200744) | Instylla, Inc. | 2020-04-21 |
| Globalcare Blood Pressure Monitor (K192609) | Globalcare Medical Technology Co., Ltd. | 2020-04-21 |
| NinesAI (K193351) | Nines, Inc. | 2020-04-21 |
| EL CAPITAN Anterior Lumber Interbody System (K192492) | Astura Medical, LLC | 2020-04-21 |
| Galileo Vertebral Body Replacement Device (K192145) | Bright Spine | 2020-04-21 |
| Pristine Scope (K193161) | Pristine Surgical | 2020-04-21 |
| HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (K192034) | Pathway, LLC | 2020-04-21 |
| DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (K200053) | Dannik | 2020-04-21 |
| DIBS (Digital Indirect Bonding System) (K192701) | Orthoselect, LLC | 2020-04-21 |
| QuickClear Mechanical Thrombectomy System (K193197) | Volcano Atheromed, Inc. | 2020-04-20 |
| uMR 570 (K200024) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-04-20 |
| Sentinel (K200600) | C-Rad Positioning AB | 2020-04-20 |
| CapKlenZ (K192382) | Star Mountain Medical, Inc. | 2020-04-20 |
| Rio Vial-to-Bag Drug Reconstitution Device (K192154) | Icu Medical | 2020-04-20 |
| KY Grosz Liquid (K193032) | Rb Health (Us), LLC | 2020-04-20 |
| CarpX (K200559) | Pavmed, Inc. | 2020-04-20 |
| MOTO PFJ System (K200122) | Medacta International S.A. | 2020-04-20 |
| Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) (K193343) | Vitalconnect, Inc. | 2020-04-20 |
| Route 92 Medical 088 Access System, 110 cm (K200121) | Route 92 Medical, Inc. | 2020-04-18 |
| S4 Screw System (K191995) | Subchondral Solutions, Inc. | 2020-04-18 |
| Rumble Tuff Electric Breast Pump (K200712) | A Cute Baby, Inc. | 2020-04-17 |
| Irradiation Cosmetic Device (K192552) | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-04-17 |
| SI-Restore Sacroiliac Joint Fixation System (K200868) | Biofusion Medical | 2020-04-17 |
| BRUIS Software Suite (K191720) | Mechanodontics, Inc. | 2020-04-17 |
| WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K200257) | Boston Scientific Corporation | 2020-04-17 |
| Kyocera Bipolar Hip System (K200709) | Kyocera Medical Technologies, Inc. | 2020-04-17 |
| LOGIQ E10 (K200158) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2020-04-17 |
| ProLift Lateral Fixated (K200338) | Life Spine, Inc. | 2020-04-17 |
| Opticross 35 15 MHz Peripheral Imaging Catheter (K200733) | Boston Scientific Corporation | 2020-04-17 |
| Diode Laser Therapy Device (K200118) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-04-17 |
| Traxcess 14 SELECT Guidewire (K200547) | MicroVention, Inc. | 2020-04-16 |
| HydroCision SpineJet System (K200729) | Hydrocision, Inc. | 2020-04-16 |
| DD Contrast (K193588) | Dental Direkt GmbH | 2020-04-16 |
| EON Portable RO Water Purification System (K200670) | Mar Cor Purification, Inc. | 2020-04-16 |
| Unicel DxH 800 Coulter Cellular Analysis System (K193124) | Beckman Coulter | 2020-04-16 |
| SIGMA High Performance (HP) Partial Knee System (K193549) | Depuy Ireland UC | 2020-04-16 |
| Philips Biosensor BX100 (K192875) | Philips Medical Systems | 2020-04-16 |
| MyCare Psychiatry Clozapine Assay Kit (DEN190028) | Saladax Biomedical, Inc. | 2020-04-16 |
| Caption Guidance (K200755) | Caption Health | 2020-04-16 |
| ARTIS Icono (K193326) | Siemens Medical Solutions USA, Inc. | 2020-04-16 |
| Molekule Air Pro RX (K200500) | Molekule, Inc. | 2020-04-15 |
| Comprehensive® Reverse Shoulder (K193373) | Biomet, Inc. | 2020-04-15 |
| 7 mm Extended Length Endoscope (K191930) | Maquet Cardiovascular, LLC | 2020-04-15 |
| 3MTM AttestTM Mini Auto-reader 490M (K200092) | 3M | 2020-04-15 |
| Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K193561) | Weihai Xingtai Packaging Products Co., Ltd. | 2020-04-15 |
| Serranator PTA Serration Balloon Catheter (K193181) | Cagent Vascular, LLC | 2020-04-15 |
| Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200181) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020-04-15 |
| AS-10 (K200887) | Canon, Inc. | 2020-04-15 |
| G-EYE System (K192588) | Smart Medical Systems , Ltd. | 2020-04-15 |
| I-View Gold and Imagen Gold Dental Sensors (K200625) | Trident S.R.L | 2020-04-15 |
| Monarch Platform (K193534) | Auris Health, Inc. | 2020-04-15 |
| ACUSON Sequoia Diagnostic Ultrasound System (K200707) | Siemens Medical Solutions USA, Inc. | 2020-04-15 |
| Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613) | Stryker Corporation | 2020-04-15 |
| Dermapose Refresh (K193363) | Puregraft, LLC | 2020-04-14 |
| COMET Lumbar Interbody Fusion Cage (K191353) | Baui Biotech Co., Ltd. | 2020-04-14 |
| Stat Profile Prime Plus Analyzer System (K200403) | Nova Biomedical Corporation | 2020-04-14 |
| Orthopedic Fixation Pin (K191803) | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| JiveX (K200703) | Visus Health IT GmbH | 2020-04-14 |
| UroLift System Procedure Kit Sterilization Tray (K192781) | Neotract, Inc. | 2020-04-14 |
| Solax Powered Wheelchair (Models: S7101, S7103) (K182400) | Dongguan Prestige Sporting Goods Co., Ltd. | 2020-04-14 |
| Vapocoolshot Mist (K193349) | Vapocoolshot, Inc. | 2020-04-14 |
| Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector (K200388) | Ga Health Company Limited | 2020-04-14 |
| Xelis Dental 2.0 (K193369) | Infinitt Healthcare Co., Ltd. | 2020-04-14 |
| KY Grosz UltraGel (K192982) | Rb Health (Us), LLC | 2020-04-14 |
| SILICONE Personal Lubricant (K191654) | Bath Concept Cosmetics (Dongguan) Co., Ltd. | 2020-04-14 |
| AcuityPDR (K200726) | Radmedix, LLC | 2020-04-13 |
| ND:YAG Laser (K193464) | Beijing Superlaser Technology Co., Ltd. | 2020-04-13 |
| ADVIA Centaur CEA Assay (K200215) | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 |
| CuraRad-ICH (K192167) | Curacloud Corp. | 2020-04-13 |
| VivAer Stylus (K200300) | Aerin Medical, Inc. | 2020-04-13 |
| Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K192850) | Qura S.R.L | 2020-04-13 |
| Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (K192838) | Spectrum Medical , Ltd. | 2020-04-13 |
| s-Clean SQ-SL Implant System Mini (K200099) | Dentis Co., Ltd. | 2020-04-13 |
| VERASENSE for Stryker Triathlon (K200665) | Orthosensor, Inc. | 2020-04-12 |
| Nerve and Muscle Stimulator (K193275) | Shenzhen Xft Medical Limited | 2020-04-11 |
| OrthAlign Plus System (K200642) | Orthalign, Inc. | 2020-04-10 |
| KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (K200072) | Kimberly-Clark Corporation | 2020-04-10 |
| VARO Plan (K200078) | 3D Industrial Imaging Co., Ltd. | 2020-04-10 |
| ACUSON Freestyle Diagnostic Ultrasound System (K200644) | Siemens Medical Solutions USA, Inc. | 2020-04-10 |
| Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (K190353) | Residential Home Sleep Services | 2020-04-10 |
| Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (K193573) | Molnlycke Health Care Us, LLC | 2020-04-10 |
| SkinStylus SteriLock MicroSystem (K200044) | Esthetic Education, LLC | 2020-04-10 |
| SIGNA Premier (K193282) | Ge Healthcare (Ge Medical Systems, LLC) | 2020-04-10 |
| Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use (K192679) | Gemtier Medical (Shanghai), Inc. | 2020-04-10 |
| DR-ID 1200SDK System (K200668) | Fujifilm Corporation | 2020-04-10 |
| Zimmer Hip Joint Replacement (K200112) | Zimmer GmbH | 2020-04-10 |
| Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) | Philips Medical Systems Nederland B.V. | 2020-04-10 |
| Rejuvapen NXT (K192138) | Refine USA, LLC | 2020-04-09 |
| i-STAT CG4+ Cartridge with the i-STAT 1 System (K200492) | Abbott Point of Care, Inc. | 2020-04-09 |