15 results · 29ms · Sources: EU EUDAMED, US FDA

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Veuron-Brain-mN1

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)

36M - Navajo Tribal Utility Authority

FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

FDA 510(k)
FDA Class 2 ·Immunology

GLUCOLEADER VALUE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RADIAL JAW 3 BIOPSY FORCEPS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·October 17, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025