16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CATS®-D Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114339·FLEXIBLE IRIS RETRACTORS 1 PK of 5
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113653·SUB-TENONS CANNULA 19GA 25MM
Fujifilm Ultrasonic Processor
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYDNEY IVF EMBRYO BIOPSY MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MONOJECT SYRINGE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·June 10, 2022
AGX
FDA UDI
Widex A/S·05706069749861·Audigy AGXWU-IP (Dark brown S-110 ) Right
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code LKK·July 3, 2013
M2A MAGNUM SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 6, 2017
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021