| UNiTi ACDF Implant System (K200301) | Pressio, Inc. | 2021-02-03 |
| Medical Face Masks (K202627) | Guilin Hbm Sanitary Protections, Inc. | 2021-02-03 |
| Arthrex Pilon Fusion System (K203294) | Arthrex, Inc. | 2021-02-03 |
| Smart SPACE Shoulder System (K202151) | Techmah Medical, LLC | 2021-02-03 |
| AXUS ES-5 Electro-Acupuncture Device (K200636) | Lhasa Oms, Inc. | 2021-02-03 |
| Easydrip Pen Needle, Easydrip Plus Pen Needle (K193422) | Sandstone Medical (Suzhou), Inc. | 2021-02-02 |
| 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On (K202096) | Ecoguard, Inc. | 2021-02-02 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553) | Canon Medical Systems Corporation | 2021-02-02 |
| Medical Face Mask (K202331) | Gemtier Medical (Shanghai), Inc. | 2021-02-02 |
| EzRay M (Model: VMX-P300) (K203667) | VATECH Co., Ltd. | 2021-02-02 |
| Disposable Medical Surgical Mask (K202511) | Improve Medical (Hunan) Co., Ltd. | 2021-02-02 |
| Fundus Camera (K202097) | Huvitz Co., Ltd. | 2021-02-02 |
| BioPoly Great Toe Hemiarthroplasty Implant (K203634) | BioPoly, LLC | 2021-02-02 |
| INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers (K203278) | Globus Medical, Inc. | 2021-02-02 |
| CellFX System (K203299) | Pulse Biosciences, Inc. | 2021-02-02 |
| Disposable Medical Surgical Masks (K202323) | Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. | 2021-02-02 |
| CTxx85 CT Scanner (K201231) | Analogic Corporation | 2021-02-02 |
| Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (K203537) | Sedecal., Sa. | 2021-02-01 |
| Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K203483) | Guilin Hbm Health Protections, Inc. | 2021-02-01 |
| FAST-FIX FLEX (K203393) | Smith & Nephew, Inc. | 2021-02-01 |
| Monopolar Hook (K203603) | Human Xtensions , Ltd. | 2021-02-01 |
| HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture (K203794) | Medos International SARL | 2021-02-01 |
| Hoffmann LRF System (K203568) | Stryker GmbH | 2021-02-01 |
| E-connect S Endo Motor with built-in Apex Locator (K201993) | Changzhou Sifary Medical Technology Co., Ltd. | 2021-01-29 |
| XYPAN Expandable Lumbar Cage System (K203531) | Aegis Spine, Inc. | 2021-01-29 |
| Prase-AP Anterior Cervical Plate System (K202878) | Gbs Commonwealth Co., Ltd. | 2021-01-29 |
| Luna® G3 BPAP 25A (K201620) | 3B Medical, Inc. | 2021-01-29 |
| Protective Face Mask for Medical Use (K202358) | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2021-01-29 |
| Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (K202310) | Wildcat Ppe, LLC | 2021-01-29 |
| VX650 (K202221) | Luneau Technology Operations | 2021-01-29 |
| Sunset Heated CPAP Tube (K201418) | Sunset Healthcare Solutions, Inc. | 2021-01-29 |
| MAGIC Infusion Catheter (K202366) | Balt USA, LLC | 2021-01-29 |
| BEE Cages (K200429) | NGMedical GmbH | 2021-01-29 |
| PediFlex Flexible Nail System (K201838) | OrthoPediatrics Corp. | 2021-01-29 |
| Ti3Z Cervical Interbody System (K202398) | Zavation Medical Products, LLC | 2021-01-29 |
| i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650) | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2021-01-29 |
| Neodent Implant System - Zirconia Implant System (K202282) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-01-29 |
| DEX Device (K191878) | Dex Surgical | 2021-01-29 |
| cobas BKV (K203220) | Roche Molecular Systems, Inc. | 2021-01-29 |
| Rapid Acoustic Pulse Device (K201801) | Soliton, Inc. | 2021-01-29 |
| EndoClot (K190677) | Endoclot Plus Co., Ltd. | 2021-01-29 |
| Visage Breast Density (K201411) | Visage Imaging GmbH | 2021-01-29 |
| Disposable Pre-calibrated Suction (K201752) | Brainlab AG | 2021-01-29 |
| Ventway Sparrow (K202970) | Inovytech Medical Solutions , Ltd. | 2021-01-29 |
| Vitality® Spinal Fixation System (K203507) | Zimmer Biomet Spine, Inc. | 2021-01-28 |
| LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) (K201016) | Huizhou Foryou Medical Devices Co., Ltd. | 2021-01-28 |
| MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (K202754) | Eresearchtechnology GmbH | 2021-01-28 |
| Michler-Kapp Cardiovascular Vent Catheter (K200289) | Kapp Surgical Instrument, Inc. | 2021-01-28 |
| GenesisZr UHT700 Zirconia (K201608) | United Dental Resources Corporation | 2021-01-28 |
| Biomet Microfixation RibFix Advantage System (K203474) | Biomet Micofixation | 2021-01-28 |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K203223) | Steris | 2021-01-28 |
| HipXpert 3D Display and Anchoring Application (K200384) | Surgical Planning Associates, Inc. | 2021-01-28 |
| BOSS 8F Balloon Guide Catheter (K203840) | Marblehead Medical, LLC | 2021-01-28 |
| Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (K202892) | Edan Instruments, Inc. | 2021-01-28 |
| Standard Sterilizable Tray (K202524) | Implant Direct Sybron Manufacturing, LLC | 2021-01-28 |
| EVOS Large Fragment Plating System (K203405) | Smith & Nephew, Inc. | 2021-01-27 |
| Wrist Electronic Sphygmomanometer (K193386) | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 |
| Vivo 45 LS (K193586) | Breas Medical AB | 2021-01-27 |
| Arm Electronic Sphygmomanometer (K193387) | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 |
| Airway Mobilescope (K201300) | Olympus Medical Systems Corp. | 2021-01-26 |
| General Radiography CXDI-CS01 (K203849) | Canon, Inc. | 2021-01-26 |
| Altus Spine HA Pedicle Screw System (K200922) | Altus Partners, LLC | 2021-01-26 |
| IBM iConnect Access (K203104) | Merge Healthcare Incorporated | 2021-01-26 |
| BTL-899ST (K202199) | Btl | 2021-01-26 |
| Blood Pressure Monitor (K202934) | Bioland Technology, Ltd. | 2021-01-26 |
| VASOBand Vascular Compression Device (K203803) | Vasoinnovations, Inc. | 2021-01-26 |
| M.U.S.T. Pedicle Screw Extension and Long Tab Implants (K203482) | Medacta International S.A. | 2021-01-26 |
| Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 (K202856) | Edan Instruments, Inc. | 2021-01-25 |
| Non-Contact Forehead Thermometer (Models UT306H & UT308H) (K203747) | Uni-Trend Technology (China) Co., Ltd. | 2021-01-25 |
| Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (K202742) | Viasonix , Ltd. | 2021-01-25 |
| VERTACONNECT TLIF Cage (K203327) | Signus Medizintechnik | 2021-01-25 |
| vatech A9 (Model : PHT-30CSS) (K203797) | VATECH Co., Ltd. | 2021-01-25 |
| Pulse Oximeter (K201468) | Shenzhen Creative Industry Co., Ltd. | 2021-01-25 |
| BD Hypodermic Syringe (K203453) | Becton, Dickinson and Company | 2021-01-25 |
| Patient Monitor (K202336) | Edan Instruments, Inc. | 2021-01-23 |
| Cytoplast Titanium-Reinforced PTFE Membranes (K201187) | Osteogenics Biomedical, Inc. | 2021-01-23 |
| Surgical Mask (K202640) | Jiangsu Medpure Biological Technology Co., Ltd. | 2021-01-22 |
| ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length (K201696) | Ethicon Endo-Surgery, LLC | 2021-01-22 |
| BRIUS Clear Aligners (K202792) | Brius Technologies, Inc. | 2021-01-22 |
| Non-Contact Forehead Thermometer (UT30H) (K203656) | Uni-Trend Technology (China) Co., Ltd. | 2021-01-22 |
| VirtueRF (K202415) | ShenB Co., Ltd. | 2021-01-22 |
| Platinum dRF Imaging System (K203010) | Apelem-Dms Group | 2021-01-22 |
| Flex-ThreadTM Distal Fibula Intramedullary Nail System (K202858) | Conventus Orthopaedics, LLC | 2021-01-22 |
| ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K201066) | Ethicon Endo-Surgery, LLC | 2021-01-22 |
| SPRINT PNS System (K202660) | Spr Therapeutics, Inc. | 2021-01-22 |
| MIIN (K193266) | Medico USA, Inc. | 2021-01-22 |
| Advanced Research Medical Trident SI Screw System (K203373) | Advanced Research Medical, LLC | 2021-01-22 |
| Nerivio, FGD000075-4.7 (K203181) | Theranica Bioelectronics , Ltd. | 2021-01-22 |
| Simply Iconic Implants (K201553) | Implant Direct Sybron Manufacturing, LLC | 2021-01-22 |
| ClearPoint Array System (K202575) | ClearPoint Neuro, Inc. | 2021-01-22 |
| NuFace Trinity Plus Device (K201782) | Carol Cole Company Dba Nuface | 2021-01-22 |
| EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform (K203131) | Edwards Lifesciences, LLC | 2021-01-22 |
| Piccolo Medical SmartPICC System (K200037) | Piccolo Medical, Inc. | 2021-01-22 |
| Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask (K202595) | Premier Guard USA, LLC | 2021-01-21 |
| Forwarts (K201366) | Pronova Laboratories BV | 2021-01-21 |
| EEA Circular Stapler with Tri-Staple Technology (K202507) | Covidien | 2021-01-21 |
| cobas CTNG for use on cobas 6800/8800 systems (K202408) | Roche Molecular Systems, Inc. | 2021-01-21 |
| Surgical Face Mask (K202904) | Jiangxi Feilikang Medical Technology Co., Ltd. | 2021-01-21 |
| EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 (K201758) | Olympus Medical Systems Corp. | 2021-01-21 |
| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |