20 results · 19ms · Sources: EU EUDAMED, US FDA

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HYPODERMIC SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704292978·

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771012733·K-Wires, Double diamond, .028-inch (.7mm) diame...

NA

FDA UDI
KEY SURGICAL, INC.·10849771049354·K-Wires, Double diamond, .028-inch (.7mm) diame...

Curve Disposable Sterile Monitor Drapes

FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250676739872·77 cm x 47 cm (32" Display) 30 pcs...

NA

FDA UDI
Zimmer, Inc.·00889024132047·

DYNATECH JD7/JD7P COLPOSCOPE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CEMENT CHISELS

FDA 510(k)
FDA Class 1 ·Orthopedic

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 24, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·October 3, 2012

ACCU-CHEK ADVANTAGE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·February 18, 2008

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·February 2, 2023

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

FDA Enforcement
Class II ·Terminated·CryoLife, Inc.·July 19, 2017

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

FDA Enforcement
Class II ·Terminated·American Optisurgical Inc·June 19, 2013