19 results · 21ms · Sources: EU EUDAMED, US FDA

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WowGoHealth Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Dandy Clear Aligners

FDA UDI
Orthly, Inc.·00860006891206·

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704294194·

NA

FDA UDI
KEY SURGICAL, INC.·10849771050268·Steinmann Pins, Single trocar threaded, 5/32-in...

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771015765·Steinmann Pins, Single trocar threaded, 5/32-in...

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018692·Obturator 4.0 x 175mm pyramid tip

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018708·Arthroscope shaft 2.7mm, 2 rigid stop cocks

HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

FREEDOM(R) STEMMED TIBIAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 22, 2011

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024

SOLITAIRE FR2

FDA Adverse Event
Death ·COVIDIEN (IRVINE)·Product code NRY·September 29, 2017

PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019

SCEPTER XC

FDA Adverse Event
Malfunction ·MICROVENTION, INC.·Product code DQY·December 6, 2023

SOLITAIRE FR2

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code NRY·September 29, 2017

PEDICLE SCREW 6X45

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021