9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE GAS LINE FILTER
FDA 510(k)
FDA Class 1
·Cardiovascular
Sphero Block
FDA UDI
Preat Corporation·00842092175347·Sphero Block Abutment Straumann BLT 3.3 x 4mm (...
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
FDA 510(k)
FDA Class 2
·Anesthesiology
OBC-096 BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·May 9, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 24, 2012
G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 9, 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