25 results · 20ms · Sources: EU EUDAMED, US FDA

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Viz RV/LV

FDA 510(k)
FDA Class 2 ·Radiology

RUSCH

FDA UDI
TELEFLEX INCORPORATED·14026704624659·RUSCH Traditional Guedel Airway Length 100mm Tr...

SPERMCARE Upper Layer - Gradient System

FDA UDI
INVITROCARE, INCORPORATED·00859268006190·SPERMCARE Upper Layer - Gradient System is a 45...

10.5mm CANNULATED ENTRY REAMER

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665032321·

Pomee

FDA UDI
POMEE CORPORATION·G15772211000·Operating scissor straight sharp/sharp

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522211000·

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR74802211001·Buccal tube Edgew./Ricketts .022" f. weld. mand...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702602067·Elvarex Forte 3/Thigh High/Slant-Open Toe-Eleph...

Stryker Performance Series

FDA UDI
STRYKER CORPORATION·04546540605665·Stryker Performance Series Sagittal Blade

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

300 PV COMPLETE ELECTROTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

VITEK 2 AST STREPTOCOCUS VANCOMYCIN

FDA 510(k)
FDA Class 2 ·Microbiology

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 28, 2017

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 23, 2011

MAILBU/SOVEREIGN (INCL DIGNITY)

FDA Adverse Event
Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code ILM·July 5, 2013

BELOTERO BALANCE

FDA Adverse Event
Injury ·ANTEIS S.A.·Product code LMH·May 11, 2021

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

FDA Enforcement
Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025