12 results · 21ms · Sources: EU EUDAMED, 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