13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GALEMED NEB-EASY NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496021742·SOLIDEA LEG, SIZE L, NOISETTE, MICRO-MASSAGING ...
RESUSCI INFLATE-A-SHIELD CPR BARRIER
FDA 510(k)
FDA Class 2
·Anesthesiology
TEETHMATE F-1
FDA 510(k)
FDA Class 2
·Dental
INCLUSIVE TAPERED IMPLANT 4.7 MMD X 10 MML X 4.5 MMP
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 5, 2024
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·March 26, 2013
DEPUY
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code JWH·March 14, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008
EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 3, 2025
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014