10 results · 23ms · Sources: EU EUDAMED, US FDA

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BONE GRAFT SYRINGE, MODEL 8600-00X0

FDA 510(k)
FDA Class 2 ·General Hospital

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

SEE H10

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

KYPHON XPANDER II EU

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·March 27, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011

COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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

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

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021