| Surgical Face Mask (K213617) | Megasoft (China) Co., Ltd. | 2022-02-11 |
| NPseal (K212971) | Guard Medical, Inc. | 2022-02-10 |
| Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters (K211327) | CathRx, Ltd. | 2022-02-10 |
| Instylla Delivery Kit (K213632) | Instylla, Inc. | 2022-02-10 |
| Action Trackchair Hawk (K202728) | Action Manufacturing, Inc. | 2022-02-10 |
| Micro Catheter (K202926) | Shanghai Heartcare Medical Technology Co., Ltd. | 2022-02-10 |
| NervAlign Nerve Cuff (K202234) | Renerve, Ltd. | 2022-02-10 |
| Zeolite Hemostatic Gauze (K211570) | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2022-02-10 |
| GPC Intraheal Intramedullary Nailing System (K203811) | Gpc Medical Limited | 2022-02-10 |
| Pure-Vu EVS System (K220007) | Motus GI Medical Technologies , Ltd. | 2022-02-10 |
| Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (K212211) | Vascular Solutions, LLC | 2022-02-09 |
| SDC4K Information Management System with Device and Voice Control Package (K220108) | Stryker Endoscopy | 2022-02-09 |
| Actively Trying Personal Lubricant Unfragrance (K212705) | CC Wellness, LLC | 2022-02-09 |
| PELNAC Wound Matrix (K213573) | Gunze Limited | 2022-02-09 |
| CloudCath Peritoneal Dialysis Drain Set Monitoring System (K212658) | Cloudcath | 2022-02-09 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) | Cepheid | 2022-02-09 |
| Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers (K214011) | Medtronic Sofamor Danek USA, Inc. | 2022-02-09 |
| Redline (K213297) | Johns Dental Laboratories | 2022-02-09 |
| DeGen Navigated Instrumentation (K213918) | Degen Medical | 2022-02-09 |
| Veinoflow SCD (Model: LBTK-M-I 5006) (K213313) | Dalian Labtek Science & Development Co., Ltd. | 2022-02-09 |
| Infrascanner (K211617) | Infrascan, Inc. | 2022-02-09 |
| Lucy Breast Pump (K213311) | Willow Innovations, Inc. | 2022-02-09 |
| R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (K212167) | Vascular Solutions, LLC | 2022-02-09 |
| Rapid (K213165) | Ischemaview, Inc. | 2022-02-08 |
| AcQCross Qx Integrated Transseptal Dilator/Needle (K220047) | Acutus Medical, Inc. | 2022-02-08 |
| O'Star Nitrile Examination Gloves Powder Free (K213058) | Star Investment and Trade Joint Stock Company | 2022-02-08 |
| PathBuilder Steerable Introducer (K211530) | Shanghai Microport EP Medtech Co., Ltd. | 2022-02-08 |
| ELEC-LED (K201191) | Micro-Nx Co., Ltd. | 2022-02-07 |
| Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431) | Biomet, Inc. | 2022-02-07 |
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |
| Veuron-Brain-pAb2 (K213801) | Heuron Co., Ltd. | 2022-02-04 |
| Revolution Ascend (K213938) | Ge Healthcare Japan Corporation | 2022-02-04 |
| HOLLYWOOD SPECTRA Laser System (K213569) | Lutronic Corporation | 2022-02-04 |
| F3D-C2 Cervical Stand-Alone System (K211417) | Corelink, LLC | 2022-02-04 |
| Magnifico Open, Magnifico MSK (K212419) | Esaote, S.p.A. | 2022-02-04 |
| Radialis PET Camera (K214062) | Radialis, Inc. | 2022-02-04 |
| MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070) | CooperVision, Inc. | 2022-02-04 |
| Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (K220053) | Fujifilm Corporation | 2022-02-04 |
| Micro C Medical Imaging System, M01 (K212654) | Oxos Medical, Inc. | 2022-02-04 |
| Noris Medical Dental Implants System (K210356) | Noris Medical , Ltd. | 2022-02-04 |
| smart-sync (K212271) | Northh Medical GmbH | 2022-02-04 |
| BD Vacutainer UltraTouch Push Button Blood Collection Set (K212724) | Becton, Dickinson and Company | 2022-02-04 |
| Cryo 7 (K220020) | Zimmer Medizinsysteme GmbH | 2022-02-04 |
| Digital Radiography CXDI-Pro, Digital Radiography D1 (K220098) | Canon, Inc. | 2022-02-04 |
| VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) (K212849) | Biomérieux, Inc. | 2022-02-04 |
| Stryker Resorbable Fixation System (K213777) | Stryker Leibinger Micro Implants | 2022-02-04 |
| Genex Bone Graft Substitute (K212721) | Biocomposites, Ltd. | 2022-02-04 |
| Healing Abutment, Cover Screw (K210826) | Megagen Implant Co., Ltd. | 2022-02-03 |
| Ambu® aScope™ Gastro, Ambu® aBox™2 (K212382) | Ambu A/S | 2022-02-03 |
| LifePath Remote Patient Monitoring Platform (K211822) | Elastic Care Incorporated | 2022-02-03 |
| Soniquence Reusable Neutral Plate (K220071) | Soniquence, LLC | 2022-02-03 |
| MectaScrew Extension (K203335) | Medacta International S.A. | 2022-02-03 |
| Contour ProtégéAI (K213976) | Mim Software, Inc. | 2022-02-03 |
| Sonopet iQ Ultrasonic Aspirator System (K213824) | Stryker Corporation | 2022-02-03 |
| EVOCLEAN CLEANsert Ultrasonic Insert (K210832) | Ttbio Corp. | 2022-02-02 |
| NATtrol BD MAX Vaginal Panel External Controls (K201403) | Zeptometrix | 2022-02-02 |
| Viveve 2.0 System (K213814) | Viveve, Inc. | 2022-02-02 |
| TeesuVac Breast Biopsy Device Mark 1 (K212079) | Teesuvac Aps | 2022-02-02 |
| EndoSerter-PL (K203586) | Corneagen, Inc. | 2022-02-02 |
| Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211603) | Pegavision Corporation | 2022-02-02 |
| Rosso (K211228) | Quanta System Spa | 2022-02-02 |
| Sentient Manufacturing Laser Fiber (K213554) | Sentient Manufacturing , LLC | 2022-02-02 |
| PALACOS MV pro (K213812) | Heraeus Medical GmbH | 2022-02-02 |
| Exeter® X3® RimFit® Cup (K213701) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium (K212410) | Shenzhen Vitavitro Biotech Co., Ltd. | 2022-02-01 |
| HotDog Warming Mattress + Return Electrode (K210727) | Augustine Temperature Management, LLC | 2022-02-01 |
| CO2 Laser Equipment (K212611) | Beijing Globalipl Development Co., Ltd. | 2022-02-01 |
| Home use hair removal device, model: Precise Touch Pro (K213830) | Iluminage Beauty Co., Limited | 2022-02-01 |
| JETi AIO Peripheral Thrombectomy System (K213565) | Walk Vascular, LLC | 2022-02-01 |
| X-Guide® Surgical Navigation System (K211701) | X-Nav Technologies, LLC | 2022-02-01 |
| Permadyne (K220257) | 3M Deutschland GmbH | 2022-02-01 |
| Infinity Acute Care System (IACS) Monitoring System (K203088) | Draeger Medical Systems, Inc. | 2022-02-01 |
| Alltest Pregnancy Rapid Combo Test Cassette (K203272) | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| 8mm Monopolar Curved Scissors (K220023) | Intuitive Surgical, Inc. | 2022-01-31 |
| MIS Precision Chevron Bunion System (K211628) | Relja Innovations, LLC | 2022-01-31 |
| DIAPLUS Universal (K213401) | DiaDent Group International | 2022-01-31 |
| SKR 3000 (K213908) | Konica Minolta, Inc. | 2022-01-31 |
| Primary Relief (K213188) | Dyansys, Inc. | 2022-01-31 |
| SyntheCel Dura Repair (K212943) | Synthes (USA) Products, LLC | 2022-01-28 |
| Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs (K213325) | Anhui Xinyisheng Medical Technology Co.,Ltd | 2022-01-28 |
| Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U (K212341) | Qura S.R.L | 2022-01-28 |
| Optiflow Oxygen Kit (K211096) | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 |
| Surgical Masks (K212120) | Hubei Xinxin Non-Woven Co., Ltd. | 2022-01-28 |
| ShinEvac Smoke Evacuation Pencil (K213317) | Shining World Health Care Co., Ltd. | 2022-01-28 |
| Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution (K213142) | Shen Wei USA, Inc. | 2022-01-28 |
| Platform treatment system (K203395) | Shanghai Apolo Medical Technology Co., Ltd. | 2022-01-28 |
| BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants (K212533) | Institut Straumann AG | 2022-01-28 |
| QuikPass Catheter (K214106) | Traverse Vascular, Inc. | 2022-01-28 |
| Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 (K213082) | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-01-28 |
| iHealth infrared Ear thermometer PT5 (K212598) | Andon Health Co, Ltd. | 2022-01-28 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |
| STEP-1 PumEtch (K213093) | Rounding Third, LLC | 2022-01-28 |
| syngo.CT Brain Hemorrhage (K203260) | Siemens Medical Solutions USA, Inc. | 2022-01-28 |
| X-CUBE i8, X-CUBE i9 (K213523) | Alpinion Medical Systems Co., Ltd. | 2022-01-28 |
| SmartAdjust technology (K203774) | Insulet Corporation | 2022-01-27 |
| Intermittent Catheter (Not Finalized) (K211436) | Hollister Incorporated | 2022-01-27 |
| Sim&Size (K212373) | Sim&Cure | 2022-01-27 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (K211589) | Remington Medical, Inc. | 2022-01-27 |
| Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (K213489) | Wishbone Medical, Inc. | 2022-01-27 |
| RA-T59 Wrist blood pressure monitor (K212312) | Lotusnine Medical Limited | 2022-01-27 |