11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORIAN DRILLABLE
FDA 510(k)
FDA Class 2
·Orthopedic
NORIAN DRILLABLE INJECT 10CC-STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018
IM-5B MICROINJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 18, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 28, 2024
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 23, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 1, 2011
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
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