17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
M1 Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM
!NSURE FECAL OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
PORTA OPTIMUM SOLDER 710
FDA 510(k)
FDA Class 2
·Dental
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·October 6, 2024
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·March 5, 2024
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·March 5, 2024
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DRE·August 5, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2013
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 5, 2018
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·May 1, 2024
UNK - IMPLANT
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·November 26, 2025
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·October 6, 2024
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