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

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ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450509708·

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)

FDA 510(k)
FDA Class 2 ·Cardiovascular

CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·May 6, 2013

UNKNOWN_CORK_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·September 16, 2014

ARTISAN

FDA Adverse Event
Death ·HANSEN MEDICAL·Product code DXX·May 3, 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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024