12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MARK I THERMAL IMAGER
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751026·Sterile Single Use Burs - ISO Code 801-016M
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365106538·
BD SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·January 16, 2024
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·March 27, 2013
DISPOSABLE SUTURE PLACEMENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FHQ·March 18, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·April 4, 2008
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 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