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