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