16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
FDA 510(k)
FDA Class 2
·Cardiovascular
ETEST LINEZOLID
FDA 510(k)
FDA Class 2
·Microbiology
VAMOS ANESTHETIC GAS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
INFINION 16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 11, 2023
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 29, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 25, 2008
PROPEX
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·April 27, 2011
IMPL TAPERED SP 3.7MM 10M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 27, 2023
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 3, 2023
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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