11 results · 20ms · Sources: EU EUDAMED, US FDA

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EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER

FDA 510(k)
FDA Class 2 ·Orthopedic

145-DEG PE 36MM HUM LINER +0

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·December 10, 2024

Victoria Klein

FDA UDI
Diversified Products, Inc.·00842894127131·

SYNTHES SYNMESH SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ASTRALIS 10, MODELS # 559588, 561859

FDA 510(k)
FDA Class 2 ·Dental

LIFEPAK CR(R) PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

COULTER® LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 6, 2013

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDARY OF ICAD·Product code JAD·September 16, 2014

7MM EXTENDED LENGTH ENDOSCOPE

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR·Product code GCJ·April 14, 2011

NUVASIVE HELIX ACP SYSTEM

FDA Adverse Event
Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

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