12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Contour Light CL-100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112908·CORNEAL TREPHINE BLADE7.25MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112489·BARRON VACUUM TREPHINE 7.25MM
EMPIRE N BLOOD PRESSURE MANOMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
AMEDICA DRUG SCREEN THC TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 12, 2011
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013
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