11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SALEM/RESCE INTUBATION GUIDE
FDA 510(k)
FDA Class 1
·Anesthesiology
Bardia® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741018367·Bardia® Urethral Catheter - Red Rubber
GOLDEN-RULE SCALING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IBA PROTON THERAPY SYSTEM- PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
RESOLUTE INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·October 24, 2012
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
LUMINOS AGILE
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code JAA·May 26, 2015
IVAC
FDA Adverse Event
Malfunction
·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·October 30, 1998
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, 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