9 results · 18ms · Sources: EU EUDAMED, US FDA

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DIAGNOSTIC ULTRASOUND UFS 1005

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPORTSFRAME REGULAR BLACK - 902408

Device
EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

RHYTHM OF LIFE, MODEL R0901-05

FDA 510(k)
FDA Class 2 ·Cardiovascular

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code GAM·June 30, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·November 18, 2010

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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