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.
|
