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

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N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

FDA 510(k)
FDA Class 2 ·Immunology

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776291990·Iris Scissors

NA

FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312357·

NA

FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312340·

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

FDA 510(k)
FDA Class 2 ·Orthopedic

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

FDA 510(k)
FDA Class 3 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

ZOOM CRITICAL CARE BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013

ASKU

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·April 13, 2011

DLC FLEX DRILL SHAFT

FDA Adverse Event
Death ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 22, 2008

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