9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HAND PERCUSSOR CUP #65210
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182147·
ABX MICROS CRP
FDA 510(k)
FDA Class 2
·Hematology
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
E1 VNGD PS TIBIAL BEARING 79/83X10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 9, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 24, 2012
TANDEMRX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GCJ·August 17, 2010
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