11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ORTHO H FILM
FDA 510(k)
FDA Class 1
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293906·
Hermes Medical Imaging Suite v5.7
FDA 510(k)
FDA Class 2
·Radiology
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
FDA 510(k)
FDA Class 2
·Hematology
START-X TIP EMS INSERT 3
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·November 21, 2023
START-X TIP SATELEC INSERT 3
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·October 24, 2022
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·October 4, 2012
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 14, 2015
QUANTUM MAVERICK BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 27, 2010
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024