18 results · 22ms · Sources: EU EUDAMED, US FDA

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SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

FDA 510(k)
FDA Class 2 ·Neurology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496013488·MARILYN 30 SHEER, SIZE M, NERO, GRADUATED COMPR...

OPHELIA ROE

FDA UDI
FGX INTERNATIONAL INC.·00708820706262·

OPHELIA ROE

FDA UDI
FGX INTERNATIONAL INC.·00193033500354·

Navagio

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

ATAC PAK AST REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNCHRON CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·March 20, 2013

COULTER® LH700 SERIES RETIC PAK

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code GGK·March 10, 2011

MARQUIS DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code LWS·March 10, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

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