14 results · 21ms · Sources: EU EUDAMED, US FDA

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MERIDIAN GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO-LOGIC SLEEPSCAN NETLINK

FDA 510(k)
FDA Class 2 ·Neurology

RENEGADE STC 18 MICROCATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 6, 2013

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 16, 2014

LEVEEN NEEDLE ELECTRODE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GEI·May 18, 2011

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 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

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018