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

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TERRAQUANT MQ2000 LASER THERAPY DEVICE

FDA 510(k)
FDA Class 2 ·Physical Medicine

APOLLO Ankle Fracture Plating System

FDA UDI
Glw, Inc.·18435711004198·APOLLO Ankle Fracture Plates / 4.3mm / Non-Lock...

IBP adapter cable (12-pin to 6-pin)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904086842·

THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 21, 2016

IBP ELB INT. ULNA LRG RGT LNG STM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDC·June 24, 2016

BD INTIMA II¿ IV CATHETER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·May 16, 2019

BD INTIMA-II Y 26GAX0.56IN PRN SLM PVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 7, 2024

MEDRAD VERIS MR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·MEDRAD, INC.·Product code MWI·March 7, 2013

HUDSON HEATED-WIRE VENTILATOR CIRCUIT, DUALLIMB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BZO·February 23, 2011

FINELINE II

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

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