| FDA Decision Data | Product | Manufacturer |
| 11/1/2022 | System, Test, Automated Blood Grouping And Antibody: DG Gel 8 Neutral | Diagnostic Grifols, S. A. |
| 11/1/2022 | Pose™ Health Care Surgical Mask | America’s Supply Chains |
| 11/1/2022 | Current Health System | Current Health Ltd. |
| 11/1/2022 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. |
| 11/1/2022 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. |
| 11/1/2022 | Klarity SRS Baseplate, Klarity Promise Baseplate | Klarity Medical & Equipment (GZ) Co., Ltd. |
| 11/1/2022 | Dolphin Blue Imaging | Patterson Dental Supply, Inc. |
| 11/1/2022 | Back 3 COLOR / Electrosurgical cutting and coagulation device and accessories | SWIMS America Corp |
| 11/1/2022 | Sterilization Process Indicator | 3M Company |
| 11/2/2022 | Manual Surgical Instrument For General Use | Asahi Polyslider Co., Ltd. |
| 11/2/2022 | Ophthalmic Laser | Ellex Medical Pty Ltd |
| 11/2/2022 | Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill | Bien-Air Surgery SA |
| 11/3/2022 | Posterior Cervical Screw System | Osseus Fusion Systems |
| 11/3/2022 | Intervertebral Body Fusion Device | Aegis Spine, Inc. |
| 11/3/2022 | Stethoscope | Sound Land Corp. |
| 11/3/2022 | Blood Lancets | Owen Mumford Ltd |
| 11/3/2022 | Electrosurgical Cutting And Coagulation Device And Accessories | Cutera Inc. |
| 11/3/2022 | Orthodontic plastic bracket | Graphy Inc. |
| 11/3/2022 | Intravascular Administration Set | NP Medical |
| 11/3/2022 | Ophthalmic Photocoagulator | Vortex Surgical Inc |
| 11/3/2022 | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | CellReturn Co., LTD. |
| 11/3/2022 | Piston Syringe | Berpu Medical Technology Co., Ltd |
| 11/4/2022 | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis | United Orthopedic Corporation |
| 11/4/2022 | C-reactive protein immunological test system | Procise Diagnostics |
| 11/4/2022 | Digital Therapy Device For Amblyopia | Luminopia, Inc. |
| 11/4/2022 | Single/Multiple Component Metallic Bone Fixation Appliances And Accessories | Auxein Medical Private Limited |
| 11/4/2022 | Disposable Medical Face Mask | Wellmed Dental Medical Supply Co., Ltd. |
| 11/4/2022 | Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | Roche Molecular Systems, Inc. |
| 11/4/2022 | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories; Smooth or Threaded Metallic Bone Fixation Fastener | Acuitive Technologies, Inc./BioVera, Inc. |
| 11/4/2022 | Glucose test system | Apex BioTechnology Corp. |
| 11/4/2022 | Bone Cutting Instrument and Accessories | Neocis Inc. |
| 11/4/2022 | Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis | Signature Orthopaedics Pty Ltd. |
| 11/4/2022 | Radiation therapy beam-shaping block | VHA Dean |
| 11/4/2022 | Piston Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
| 11/4/2022 | Cutaneous Electrode | Guangdong Comytens Medical Technology Co., Ltd |
| 11/4/2022 | Percutaneous Catheter | Penumbra, Inc |
| 11/4/2022 | Intervertebral Body Fusion Device | Vy Spine, LLC |
| 11/4/2022 | Smooth Or Threaded Metallic Bone Fixation Fastener | Medartis Inc. |
| 11/4/2022 | Assisted Reproduction Accessories | TMRW Life Sciences, Inc |
| 11/4/2022 | Powered inflatable tube massager | Aquilo SPorts LLC |
| 11/4/2022 | Piston syringe | Medwell Technology Ltd |
| 11/5/2022 | Cytomegalovirus Nucleic Acid Detection Device For Congenital Cytomegalovirus Infection | DiaSorin Molecular LLC |
| 11/7/2022 | Dental Handpiece And Accessories | Lares Research |
| 11/7/2022 | AJK Engineering, Inc. | |
| 11/7/2022 | Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation |
| 11/7/2022 | HemoSphere Advanced Monitor | Edwards Life Sciences LLC |
| 11/7/2022 | Impression Material | HDI, Inc. |
| 11/8/2022 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. |
| 11/8/2022 | Endoscope and accessories | Diversatek Healthcare |
| 11/8/2022 | Percutaneous Cathete | Medtronic |
| 11/8/2022 | Unipolar Endoscopic Coagulator-Cutter and Accessories | Gynesonics, Inc. |
| 11/8/2022 | Medical image management and processing system | Qingdao Hisense Medical Equipment Co., Ltd |
| 11/8/2022 | Radiological Computer Aided Triage And Notification Software | Ever Fortune AI Co., Ltd. |
| 11/8/2022 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, INC. |
| 11/9/2022 | Optical Coherence Tomography | Optovue, Inc. |
| 11/9/2022 | Spinal Intervertebral Body Fixation Orthosis | CTL Medical Corporation |
| 11/9/2022 | Radionuclide brachytherapy source | GT Medical Technologies |
| 11/9/2022 | Bone Plate | Stryker Leibinger GmbH & Co. KG |
| 11/9/2022 | Newborn screening test for severe combined immunodeficiency disorder (SCID) | PerkinElmer Inc |
| 11/9/2022 | Endoscope and Accessories | Shanghai AnQing Medical Instrument Co., Ltd |
| 11/9/2022 | Endosseous Dental Implant | Southern Implants (Pty) Ltd |
| 11/9/2022 | Ultrasonic pulsed doppler imaging system | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
| 11/9/2022 | Ophthalmic Laser | Iridex Corporation |
| 11/9/2022 | Ultrasonic pulsed doppler imaging system | Exo Imaging Inc. |
| 11/10/2022 | Amphetamine test system | Vivachek Biotech (Hangzhou) Co., Ltd |
| 11/10/2022 | Bone Plate | Microware Precision Co., Ltd. |
| 11/10/2022 | Cortical Electrode | Spes Medica SRL |
| 11/10/2022 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. |
| 11/10/2022 | Infusion Pump | Amsino International Inc. |
| 11/10/2022 | Thyroid Stimulating Hormone Test System | Beckman Coulter, Inc. |
| 11/10/2022 | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Tentech Co. Ltd. |
| 11/10/2022 | Embolectomy Catheter | DeVoro Medical, Inc |
| 11/10/2022 | Endosseous Dental Implant Abutment | MegaGen Implant Co., Ltd. |
| 11/10/2022 | Medical image management and processing system | FUJIFILM Corporation |
| 11/10/2022 | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea | Solbaro Co., Ltd |
| 11/10/2022 | Surgical Apparel | Entreprise Premont Inc. |
| 11/10/2022 | Surgical Apparel | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri |
| 11/10/2022 | Endoscope And Accessories | GA Health Company Limited |
| 11/10/2022 | Denture Relining, Repairing, Or Rebasing Resin | SprintRay Inc. |
| 11/10/2022 | Endoscope And Accessories | Karl Storz Endoscopy America, Inc. |
| 11/10/2022 | Bronchoscope (flexible or rigid) and accessories | FUJIFILM Corporaton |
| 11/10/2022 | High permeability hemodialysis system | Quanta Dialysis Technologies Ltd |
| 11/10/2022 | Shoulder joint metal/polymer semi-constrained cemented prosthesis | Catalyst OrthoScience, Inc. |
| 11/10/2022 | Campylobacter Fetus Serological Reagent | Meridian Bioscience Israel Ltd. |
| 11/10/2022 | Hypodermic Single Lumen Needle | Bard Access Systems |
| 11/10/2022 | Medical image management and processing system | Coreline Soft Co.,Ltd |
| 11/10/2022 | Suprapubic urological catheter and accessories | Boston Scientific Corporation |
| 11/10/2022 | Retinal Diagnostic Software Device | AEYE Health, Inc. |
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