17 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LACTOSORB TIBIAL L-15 SCREW AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033233·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
FDA 510(k)
FDA Class 1
·General Hospital
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014
D903 DIDECO AVANT 2 VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 9, 2024
IT PADOVA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013
D903 DIDECO AVANT VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013
RENEGADE? HI-FLO? FATHOM? KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·April 3, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MND·March 30, 2011
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 25, 2014
C20441 IL HAIFA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024