| HALO (K211788) | Nicolab B.V. | 2021-07-08 |
| SurroundScope System (K210104) | 270surgical , Ltd. | 2021-07-08 |
| Straumann RidgeFit Implants (K211052) | Institut Straumann AG | 2021-07-08 |
| END 200 Endoscopic Tubeset (K202922) | Palliare , Ltd. | 2021-07-08 |
| Grappler Suture Anchor System (K211002) | Paragon 28, Inc. | 2021-07-07 |
| Arterial Catheter (K201726) | Haolang Medical USA Corporation | 2021-07-07 |
| Surgical Mask (K210524) | Changzhou Holymed Products Co., Ltd. | 2021-07-07 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K211818) | Hyperfine, Inc. | 2021-07-07 |
| Axium Detachable Coil; Axium Prime Detachable Coil (K203432) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 |
| ONE Planner Hip (K210653) | Orthosoft D/B/A Zimmer Cas | 2021-07-07 |
| Infrared Forehead Thermometer (K202741) | Shenzhen Combei Technology Co., Ltd. | 2021-07-07 |
| SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (K210497) | SeaSpine Orthopedics Corporation | 2021-07-07 |
| Pantheon IBFD (K203003) | Pantheon Spinal | 2021-07-07 |
| Surgical Gowns (K210215) | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2021-07-07 |
| Hydrozid (K201740) | Medilink A/S | 2021-07-07 |
| KARL STORZ Metal Sterilization Trays (K203198) | Karl Storz Endoscopy America, Inc. | 2021-07-06 |
| DEKA Motus AZ (K211821) | El.En Electronic Engineering Spa | 2021-07-06 |
| SafeCross Transseptal Puncture and Introducer (TSP/I) System (K203459) | East End Medical I, LLC | 2021-07-06 |
| AcuPebble SA (K210480) | Acurable Limited | 2021-07-06 |
| TRIOCLEAR System (K193622) | Perfection Aligner System Hong Kong Limited | 2021-07-06 |
| NUVO CF Implant System (K203309) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021-07-06 |
| LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (K202241) | Hamilton Thorne, Inc. | 2021-07-02 |
| The Alma Hybrid Laser System (K203441) | Alma Lasers , Ltd. | 2021-07-02 |
| SyntrFuge System (K203800) | Syntr Health Technologies, Inc. | 2021-07-02 |
| Selethru(TM) NC PTCA Balloon Dilatation Catheter (K211393) | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 |
| Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (K211422) | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021-07-02 |
| LX9max (K203498) | Daesung Maref Co., Ltd. | 2021-07-02 |
| Insulin Syringe, Insulin Syringe with Safety Retractable (K202570) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-07-02 |
| Estar-Z (K210097) | Osstem Implant Co., Ltd. | 2021-07-02 |
| RICOH MEG (K210199) | Ricoh Company, Ltd. | 2021-07-02 |
| Disposable Surgical Mask (K202954) | Xiamen Probtain Medical Techology Co., Ltd. | 2021-07-02 |
| Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask (K203347) | Suzhou Yuyue Medical Technology Co., Ltd. | 2021-07-02 |
| iQ200 System, iChemVELOCITY Automated Urine Chemistry System (K210127) | Beckman Coulter, Inc. | 2021-07-02 |
| Single-use Medical Face Mask (K203591) | Conod Medical Co., Limited | 2021-07-02 |
| ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256) | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 |
| ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (K211782) | Controlrad, Inc. | 2021-07-01 |
| Cannula for Organ Perfusion (K203262) | Bridge TO Life, Ltd. | 2021-07-01 |
| Avance Solo Negative Pressure Wound Therapy (NPWT) System (K203369) | Molnlycke Health Care Us, LLC | 2021-07-01 |
| DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K211337) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-07-01 |
| GlidePath Retro Long-Term Hemodialysis Catheter (K203575) | C.R. Bard, Inc. | 2021-07-01 |
| Pulmogine Vibrating Mesh Nebulizer (K202171) | Hcmed Innovations Co., Ltd. | 2021-07-01 |
| Bravo G4 Chamber Autoclave (K210326) | Scican , Ltd. | 2021-07-01 |
| EZ-TRAXTM Persona Knee Containment Device (K211007) | K1 Medical, LLC | 2021-07-01 |
| Snore Bandit (K210910) | Snorebandit, LLC | 2021-07-01 |
| decimal Bolus (K211511) | .Decimal, LLC | 2021-07-01 |
| Penumbra System (RED 68 Reperfusion Catheter) (K211411) | Penumbra, Inc. | 2021-07-01 |
| MAZIC Claro CAD and MAZIC Claro Press (K203672) | Vericom Co., Ltd. | 2021-07-01 |
| MAGNETOM Free.Max (K210611) | Siemens Medical Solutions USA, Inc. | 2021-07-01 |
| Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (K210560) | Philips Medical Systems | 2021-06-30 |
| Quantum Perfusion Arterial Cannula Graft (K203057) | Qura S.R.L | 2021-06-30 |
| LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE (K211768) | Waldemar Link GmbH & Co. KG | 2021-06-30 |
| Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (K203717) | Fujifilm Corporaton | 2021-06-30 |
| Pivot Breath Sensor (K201206) | Carrot, Inc. | 2021-06-30 |
| LUMINELLE DTx System (K210512) | Uvision360, Inc. | 2021-06-30 |
| Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (K210044) | Spinal Elements, Inc. | 2021-06-30 |
| Oral/Enteral Syringe with ENFit connector (K211025) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 |
| KardiaMobile 6L (K210753) | AliveCor, Inc. | 2021-06-30 |
| Stryker iBur hubs and cutting accessories (K210377) | Stryker Corporation | 2021-06-30 |
| aprevo Transforaminal IBF (K210542) | Carlsmed, Inc. | 2021-06-30 |
| Metapaste Plus (K210904) | Meta Biomed Co., Ltd. | 2021-06-30 |
| Standard Bougie, 38 Fr. (K210437) | Standard Bariatrics | 2021-06-29 |
| Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 (K203645) | Supersonic Imagine | 2021-06-29 |
| Biophotas Celluma RESTORE (K211038) | Biophotas, Inc. | 2021-06-29 |
| 12MP Color Digital Mammography LCD Monitor CL-S1200 (K203733) | Jvckenwood Corporation | 2021-06-29 |
| RayStation 10.1 (K210645) | RaySearch Laboratories AB (PUBL) | 2021-06-29 |
| Nordiwell Surprotect Face Mask (K210445) | Changzhou Combat Protective Equipment Co., Ltd. | 2021-06-29 |
| Smith & Nephew Plates and Screws (K210837) | Smith & Nephew, Inc. | 2021-06-29 |
| STAGE (K210843) | Spintech, Inc. | 2021-06-29 |
| Synergy (K210954) | Yrs Group, Inc. | 2021-06-29 |
| Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K210587) | Onetexx Sdn Bhd | 2021-06-28 |
| Diafil & Diafil Capsule (K210421) | DiaDent Group International | 2021-06-28 |
| White Nitrile Powder Free Patient Examination Glove, Non Sterile (K210775) | Onetexx Sdn Bhd | 2021-06-28 |
| CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353) | Centermed, Inc. | 2021-06-28 |
| Phantom Hindfoot TTC/TC Nail System (K210869) | Paragon 28, Inc. | 2021-06-28 |
| ENFit Disposable Enteral Syringe (K203410) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 |
| Apache Ultrasound System (K211232) | Aco Healthcare Co., Ltd. | 2021-06-25 |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (K211238) | Stryker Instruments | 2021-06-25 |
| Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (K201228) | Psychemedics Corporation | 2021-06-25 |
| BD Prevue II Peripheral Vascular Vascular Access System (K211193) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 |
| Scooter (Model: FDB01) (K201196) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2021-06-25 |
| Safety Winged Blood Collection Sets (K211293) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-06-25 |
| iTind System (K210138) | Medi-Tate , Ltd. | 2021-06-25 |
| iLab Polaris Multi-Modality Guidance System (K210889) | Boston Scientific Corporation | 2021-06-25 |
| PuraStat-GI (K210098) | 3-D Matrix, Inc. | 2021-06-25 |
| Vu-Path Ultrasound System (K203657) | Crystalline Medical | 2021-06-25 |
| 3D Echo v1.1 (K211656) | Jointvue, LLC | 2021-06-25 |
| Nitrile Glove (K211252) | Jiangsu Dihong Industry and Trade Co., Ltd. | 2021-06-25 |
| Perfit FS Dental Zirconia Fully Sintered Block (K203590) | Vatech Acucera, Inc. | 2021-06-24 |
| easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use (K210909) | Ezisurg Medical Co., Ltd. | 2021-06-24 |
| THD Procto Software System (K211623) | Thd Spa | 2021-06-24 |
| BioFire RP2.1/RP2.1plus Control Panel M441 (K202196) | Maine Molecular Quality Controls, Inc. | 2021-06-24 |
| Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand (K210423) | ArthroCare Corporation | 2021-06-24 |
| Natural Cycles (K202897) | Natural Cycles Nordic AB | 2021-06-24 |
| Virtual C DRF Digital Imaging System (K211191) | Portavision Medical, LLC | 2021-06-24 |
| Renamel Bulkfill (K211259) | Cosmedent, Inc. | 2021-06-24 |
| Cor-Knot Micro (K202551) | Lsi Solutions, Inc. | 2021-06-24 |
| ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (K210656) | Careplus (M) Sdn Bhd | 2021-06-24 |
| RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System (K210959) | Samsung Medison Co., Ltd. | 2021-06-24 |
| SMARTRELEASE Endoscopic Soft Tissue Release System (K211297) | Microaire Surgical Instruments | 2021-06-24 |
| OVOMotion Reverse Shoulder Arthroplasty System (K203375) | Arthrosurface, Inc. | 2021-06-24 |