10 results · 29ms · Sources: EU EUDAMED, US FDA

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PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517320841·CoRoent® LO Ti, 13x10x40mm 5°

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014600222·Disposable Richards Slotted Headrest, Extended

STACKABLE CAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 2, 2026

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 26, 2013

XACT CAROTID STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR GALWAY·Product code NIM·July 24, 2008

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 21, 2011

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