21 results · 22ms · Sources: EU EUDAMED, US FDA

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MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II

StaClear Syringe

FDA 510(k)
FDA Class 2 ·General Hospital

MICRO TYING FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084711·MICRO TYING FORCEPS WITH PLATFORM STRAIGHT TUNG...

Drill Guide

FDA UDI
Treace Medical Concepts, Inc.·00810111223591·Drill Guide - 15.5MM

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159007558·Lambert-Kay Anastomosis Clamp

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319742488·Dunning Elevator and Curette 8-1/4" (20.6cm), b...

Stealth Abutment

FDA UDI
BICON, LLC·00813110021328·5.0 x 6.0mm 10° Stealth Abutment - 2.0mm Post

ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE

FDA 510(k)
FDA Class 2 ·Orthopedic

EMULATE FAST SET AND EMULATE REGULAR SET

FDA 510(k)
FDA Class 2 ·Dental

FUSION QUATTRO EXTRACTION BALLOON

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024

RS GLENOID PLATE EXT CAG +10MM CAGE PEG

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·July 17, 2023

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·August 11, 2011

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

ACESSA PROVU HANDPIECE

FDA Adverse Event
Injury ·ACESSA HEALTH INC.·Product code HFG·November 8, 2021

FUSION QUATTRO EXTRACTION BALLOON

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024

Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

FDA Enforcement
Class II ·Terminated·Hill-Rom, Inc.·November 9, 2016

Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

FDA Recall
Terminated ·Hill-Rom, Inc.·Product code FSA·August 9, 2016

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014