17 results · 25ms · Sources: EU EUDAMED, US FDA

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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