11 results · 27ms · Sources: EU EUDAMED, US FDA

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OXY-ONE

FDA 510(k)
FDA Class 1 ·Anesthesiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111222863·GUYON SOUND W/THREAD 23FR

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110209·

uCentum

FDA UDI
Ulrich GmbH & Co. KG·04052536052929·Pedicle probe with ball handle, lumbar, length ...

ATLANTIS Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

VITALITY

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010

7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LGTH

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·November 30, 2012

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

FDA Enforcement
Class I ·Terminated·GE Healthcare, LLC·July 30, 2014