12 results
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35ms
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Sources: EU EUDAMED, US FDA
HALUX IRIS EXAMINATION AND SURGICAL LAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809841923·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE FU...
CONMED
FDA UDI
Conmed Corporation·10845854003855·12 X 30 X 0.25MM MICRO-AIRE SAGITAL BLADE REPLA...
CHAD THERAPEUTICS SAGE
FDA 510(k)
FDA Class 2
·Anesthesiology
VIVO 200 DPS VIVOSCAN
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PROFILE BIABUT 4.0 -Ø5.5
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
PIN LINER CONST NEUT 50ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code KWZ·April 11, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·March 16, 2011
G2 FILTER SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 28, 2008
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014