| 091 Balloon Guide Catheter (K220331) | Inneuroco, Inc. | 2022-07-29 |
| Injection Needle (K213914) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 |
| NobelProcera Zirconia N1 Base (K220048) | Nobel Biocare Services AG | 2022-07-29 |
| S-Core Implant System (K220901) | Subchondral Solutions, Inc. | 2022-07-29 |
| Tablo Hemodialysis System (K211370) | Outset Medical, Inc. | 2022-07-29 |
| Bodyport Cardiac Scale (K211585) | Bodyport, Inc. | 2022-07-29 |
| Dental Handpiece, Model CA160, CA160L, and CA500L (K220577) | Micro-Nx Co., Ltd. | 2022-07-29 |
| Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K221242) | Hunan Vsmile Biotechnology Co., Ltd. | 2022-07-29 |
| Deep Learning Image Reconstruction (K220961) | Ge Healthcare Japan Corporation | 2022-07-29 |
| Catapult Guide Sheath (K221914) | Contract Medical International, GmbH | 2022-07-29 |
| Vascette HP (hemostatic pad) (K220566) | Koag, LLC | 2022-07-29 |
| ABMD Software (K213760) | HeartLung Corporation | 2022-07-29 |
| Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) (K221251) | Guangzhou Huakai Electronic Technology Co., Ltd. | 2022-07-29 |
| EleGARD (K221901) | Advancedcpr Solutions, LLC | 2022-07-29 |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System (K221259) | Dexcom, Inc. | 2022-07-29 |
| Microstream CO2 NanoPod (K213911) | Covidien, LLC | 2022-07-29 |
| neXus Ultrasonic Surgical Aspirator System (K221235) | Misonix, Inc. | 2022-07-28 |
| TRON (K221230) | Xoran Technologies, LLC | 2022-07-28 |
| Gastrointestinal Boundary Identifier (GIBI HD) (K221898) | Reshape Lifesciences | 2022-07-28 |
| MagXtract Collection Tube (K212113) | Magbio Genomics, Inc. | 2022-07-28 |
| INERTIA CONNEXX Modular Pedicle Screw System (K221905) | Nexxt Spine, LLC | 2022-07-28 |
| Trinias (K221922) | Shimadzu Corporation Medical Systems Division | 2022-07-28 |
| Biotres (K222017) | Biotricity | 2022-07-28 |
| Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm (K221945) | Conmed Corporation | 2022-07-28 |
| Swoop Portable MR Imaging System (K221923) | Hyperfine, Inc. | 2022-07-28 |
| BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (K214122) | Becton, Dickinson and Company | 2022-07-28 |
| EXALT Model B Single-Use Bronchoscope (K222014) | Boston Scientific Corporation | 2022-07-28 |
| cvi42 Auto Imaging Software Application (K213998) | Circle Cardiovascular Imaging, Inc. | 2022-07-28 |
| OsteoCentric Spine MIS Pedicle Fastener System (K221332) | OsteoCentric Technologies | 2022-07-28 |
| Single Use Cytology Brush (K220063) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 |
| OTC DDR (K221853) | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 |
| Real Intelligence Cori (K220958) | Blue Belt Technologies, Inc. | 2022-07-27 |
| Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (K221271) | Shandong Maida Medical Technology Co., Ltd. | 2022-07-27 |
| AOK 95A Medical Mask (20200049) (K220876) | Aok Tooling Limited | 2022-07-27 |
| KeriFlex® MCP and PIP Finger Joint Prostheses (K211385) | Keri Medical SA | 2022-07-27 |
| Hummingbird Tympanostomy Tube System (K221254) | Preceptis Medical, Inc. | 2022-07-27 |
| DeepRhythmAI (K210822) | Medicalgorithmics S.A. | 2022-07-27 |
| EliA Ro52, EliA Ro60 (K210902) | Phadia AB | 2022-07-27 |
| Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (K220922) | Cochlear Americas | 2022-07-27 |
| Pegasus-X Expandable PLIF System (K221687) | GS Medical Co., Ltd. | 2022-07-27 |
| Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269) | Better Care Plastic Technology Co., Ltd. | 2022-07-27 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |
| Dornier Thulio (K213252) | Dornier Medtech America, Inc. | 2022-07-27 |
| Upper Arm Type Blood Pressure Monitor (K220886) | Shenzhen Jamr Technology Co., Ltd. | 2022-07-27 |
| CorPath GRX System (K221464) | Corindus, Inc. | 2022-07-27 |
| TransLoc 3D (K211496) | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2022-07-27 |
| AquaA (K213507) | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| reVive Light Therapy LED Cleansing System (K221430) | Led Technologies, Inc. | 2022-07-27 |
| HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (K214007) | Owens & Minor (O&M) Halyard, Inc. | 2022-07-27 |
| Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221404) | Conformis, Inc. | 2022-07-26 |
| Parcus Synd-EZ SS (K221502) | Parcus Medical, LLC | 2022-07-26 |
| Cemented Round Patella with JRNY Pegs (K221939) | Smith & Nephew, Inc. | 2022-07-26 |
| LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (K221567) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-07-26 |
| AccuMeasure System (DEN210032) | RQMIS, Inc. | 2022-07-26 |
| VyPlate Anterior Cervical Plate System (K221572) | Vy Spine, LLC | 2022-07-26 |
| LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) | DiaSorin, Inc. | 2022-07-26 |
| Gastric Lightguide (GLG) (K212407) | Naser Dib Gabinet Lekarksi Nasmed | 2022-07-26 |
| Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112) | Medela AG | 2022-07-26 |
| Viz SDH (K220439) | Viz. Ai, Inc. | 2022-07-25 |
| Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 (K220606) | Ambu A/S | 2022-07-25 |
| Paneffort 3-ply Surgical and Procedural Masks (K221409) | Paneffort, LLC | 2022-07-25 |
| Tigertriever 13 Revascularization Device (K220808) | Rapid Medical Ltd. | 2022-07-25 |
| BioFire COVID-19 Test 2 (K221460) | Biofire Defense, LLC | 2022-07-25 |
| Powder-Free Nitrile Examination Glove, Non-Sterile (K221877) | Goodgloves Industries Sdn Bhd | 2022-07-23 |
| EchoPAC Software Only, EchoPAC Plug-in (K220940) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-22 |
| BLUE 400 (K211346) | Carl Zeiss Meditec, AG | 2022-07-22 |
| TargetCool (K221234) | Recensmedical, Inc. | 2022-07-22 |
| Kentrospine PSS Pedicle Screw System (K220486) | Rivarp Medical Private Limited | 2022-07-22 |
| 10HQ701G-B (K221461) | Lg Electronics.Inc | 2022-07-22 |
| DM Converter - TiN coated (K211891) | Medacta International S.A. | 2022-07-22 |
| AI4CMR v1.0 (K220624) | Ai4medimaging Medical Solutions S.A. | 2022-07-22 |
| SECURE-LOCK (K220906) | Xiros, Ltd. | 2022-07-22 |
| C-Stem AMT LE Prosthesis (K220216) | Depuy Ireland UC | 2022-07-22 |
| Disposable Medical Face Mask (ear loop) (K221196) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-07-22 |
| Align Lumbar Interbody Fusion System (K221535) | Acuity Surgical Devices, LLC | 2022-07-22 |
| MedWand (K212975) | Medwand Solutions, Inc. | 2022-07-22 |
| Sterile Level 3 Surgical Gown (K211399) | Barco Tekstil Sanayi VE Ticaret A.S. | 2022-07-22 |
| Vivid E80, Vivid E90, Vivid E95 (K220882) | Ge Medical Systems Ultrasound And | 2022-07-22 |
| PreXion3D Explorer PRO (K221525) | Prexion Corporation | 2022-07-22 |
| BioFire JI Control Panel M420 (K203680) | Maine Molecular Quality Controls, Inc. | 2022-07-22 |
| DuraFuse Clip and Applier System (K213813) | Neuramedica, Inc. | 2022-07-22 |
| FX SPS (K213922) | Pixee Medical | 2022-07-22 |
| Synergy Marble (Model: Opasm) (K220064) | Yrs Group, Inc. | 2022-07-22 |
| 14HQ701G-B (K221394) | Lg Electronics.Inc | 2022-07-22 |
| Manual Wheelchair (K220671) | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. | 2022-07-21 |
| Life Scope PT BSM-1700 Series Bedside Monitor (K220976) | Nihon Kohden Corporation | 2022-07-21 |
| Cionic Neural Sleeve NS-100 (K221823) | Cionic | 2022-07-21 |
| Celerity Incubator (K213881) | STERIS Corporation | 2022-07-21 |
| Syringe with permanently attached needle (K213158) | Berpu Medical Technology Co., Ltd. | 2022-07-21 |
| Pump Alignment Syringe (K220184) | Jiangsu Caina Medical Co.,Ltd | 2022-07-21 |
| Wei Nasal Jet Tube (K211543) | Well Lead Medical Co., Ltd. | 2022-07-21 |
| BTI Interna Narrow/Plus Dental Implant System UnicCa (K211952) | B.T.I. Biotechnology Institute, Sl. | 2022-07-21 |
| Insufflation Retention Device (K213773) | Bpendo, LLC | 2022-07-21 |
| AutoSeg (K220039) | Ai Medic, Inc. | 2022-07-20 |
| Pediatric Nailing Platform Femur (K220679) | OrthoPediatrics Corp. | 2022-07-20 |
| AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (K213060) | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 |
| Root Apex Locator (K212178) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 |
| AF Laser (K221363) | ShenB Co., Ltd. | 2022-07-20 |
| Biofeedback Nerve and Muscle Stimulator (K220161) | Shenzhen Konmed Technology Co., Ltd. | 2022-07-20 |
| Pentaflush (K214080) | Pentaferte Italia S.R.L. | 2022-07-20 |