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

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NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O

FDA 510(k)
FDA Class 1 ·General Hospital

EYE SENTIAL

FDA UDI
FGX INTERNATIONAL INC.·00193033444597·

SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ELS CANNULA (KIT), MODEL M1210-88,M1510-88

FDA 510(k)
FDA Class 2 ·Cardiovascular

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022

XPS® BUR - STYLUS TRANSNASAL

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017

11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 1, 2013

SECURE 2 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 3, 2011

ZODIAC PEDICLE SCREW SYSTEM

FDA Adverse Event
Malfunction ·ALPHATEC SPINE, INC.·Product code MNI·March 12, 2008

Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

FDA Recall
Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

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