12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HELIOSIT
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Zimmer, Inc.·00889024144873·
ACUMED
FDA UDI
Acumed LLC·10806378103421·Small Fragment Base Set Lid, VA
NA
FDA UDI
Zimmer, Inc.·00889024144880·
SD CHECK GOLD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2014
NUT
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTN·October 24, 2012
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 17, 2010
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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