15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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icobrain aria
FDA 510(k)
FDA Class 2
·Radiology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025026·R65 Trolley
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016142·
Tiger Shark System
FDA UDI
Choice Spine, LP·00840996166003·TIGER SHARK,STERILE,STR,9X24X7,12 DEG
AIR SAFETY HEPA, MODEL 3500
FDA 510(k)
FDA Class 2
·Anesthesiology
Rumble Tuff Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·September 9, 2011
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·July 22, 2013
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
FDA Enforcement
Class II
·Ongoing·North American Rescue LLC.·October 8, 2025
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014