13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LOW TRAUMA ARTERIAL FILTER H-640
FDA 510(k)
FDA Class 2
·Cardiovascular
GN Otometrics A/S
FDA UDI
NATUS MANUFACTURING LIMITED·05713315003561·Silicone Eartip, 11 mm semi gray, mushroom
ANTIGEN CONTROL CELLS
FDA 510(k)
FDA Class 2
·Microbiology
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FLOEY CATHETER W TEMP
FDA Adverse Event
Injury
·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 14, 2012
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2015
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024