9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
AFGA VIDEO IMAGER, VARIOUS MODELS
FDA 510(k)
FDA Class 2
·Radiology
SOLID STATE X-RAY IMAGING DEVICES
FDA 510(k)
FDA Class 2
·Radiology
1.5T OPTIMA MR430S
FDA 510(k)
FDA Class 2
·Radiology
BD PLASTIPAK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 10, 2019
VANG SSK PSC TIB BRG 12X71/75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 30, 2014
APOGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 2, 2013
ULTIMA COLL STM, 10/12 SZ 1M
FDA Adverse Event
Injury
·DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS·Product code KWL·November 12, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, 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