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

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PIEZOSURGERY DEVICE

FDA 510(k)
FDA Class 2 ·Dental

LEONE SPA

FDA UDI
LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

Equinoxe

FDA UDI
Exactech, Inc.·10885862610904·Baseplate Trial, 8 Deg R Post Aug

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

AT HOME DRUG TEST, MODEL 9079

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CT CORD IQ OPTION 1.0

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 16, 2023

CATH CARD PUD W/BA

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES INC.·Product code JXG·August 5, 2005

GRAFTON PLUS¿ DBM

FDA Adverse Event
Malfunction ·Product code NUN·August 28, 2020

GRAFTON PLUS¿ DBM

FDA Adverse Event
Malfunction ·Product code NUN·August 28, 2020

MERIDIAN FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 11, 2013

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·March 15, 2011

CONTAK RENEWAL 4 RF

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012