16 results · 23ms · Sources: EU EUDAMED, US FDA

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LIGHTSPEED 4.0 CT SCANNER SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
Smith & Nephew, Inc.·23596010091134·BONE TUNNEL PLUG NON-CANNULATED, ...

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033508718·

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033508701·

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033508695·

VERDICT -II BAR/BZO

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700

FDA 510(k)
FDA Class 2 ·Anesthesiology

OSSEOTITE® CERTAIN® IMPLANT 3.25 X 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 2, 2022

VALIANT THORACIC STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 20, 2013

APEXPRO TELEMETRY SYSTEM

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·February 3, 2011

GEM III AT

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·March 10, 2008

SHELL POROUS WITH CLUSTER HOLES

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020

ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023

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

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014