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

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LUNG AEROSOL UNIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

TLX

FDA UDI
Nuvasive, Inc.·00887517741028·TLX Tamp

AirLife™

FDA UDI
VYAIRE MEDICAL, INC.·10190752176393·Arterial Blood Sampler

BaseVac

FDA UDI
R. E. Morrison Equipment Inc·D13028000230·1.5 User All-In-One Vacuum w/ Integrated Air Wa...

Trimline

FDA UDI
ORMCO CORPORATION·00889989051278·UPPER LEFT FIRST MOLAR TRIMLINE BAND SIZE 23

Mini Standard Edgewise

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746113635·DB BKT MINI STANDARD EDGEWISE UNIV CUSP 022 T=0...

Rampart O

FDA UDI
SPINEOLOGY INC.·M7402800023·9x35mm Trial

MODIFICATION TO: SPIRIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

FRIENDLY LIGHT ER:YAG PULSED LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ANALYTICAL E MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 8, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 17, 2012

RESTORE PRIME ADVANCED

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2010

LINER FOR METAL BACK GLENOID SMALL-R 2

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020

SMR HUMERAL EXTENSION + 9 MM

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code KWS·September 28, 2018

EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

FDA Enforcement
Class II ·Terminated·Dako North America Inc.·November 11, 2015

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025