13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-use Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRA HIGH PRESSURE INJECTOR LINES
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSCARE, MODEL TENS XL-2
FDA 510(k)
FDA Class 2
·Neurology
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
ENDOSCOPIC MULTIFEED STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 27, 2014
SYNCHROMED EL
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 14, 2023
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 13, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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