15 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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FRAXEL III SR LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071051·MISS RELAX 70 SHEER, SIZE XL, SABBIA, GRADUATED...
NA
FDA UDI
KEY SURGICAL, INC.·00849771052296·K-Wire and Steinmann Pin Dispensers, No Dispen...
ANNULOFLO SYSTEM, MITRAL MODEL AR700
FDA 510(k)
FDA Class 2
·Cardiovascular
RX EVEREST
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2021
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 22, 2013
EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·April 27, 2011
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2019
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
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017