10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Oral-B Dry Mouth Oral Rinse
FDA 510(k)
FDA Unclassified
·Unknown
LSI Silver Self Adhesive, Disposable Electrodes
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007872·3" Round Foam
SERENOCEM, MODEL BC 010
FDA 510(k)
FDA Class 2
·Dental
STAT PROFILE PHOX PLUS L ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 17, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013
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