9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
uDR 380i Pro
FDA 510(k)
FDA Class 2
·Radiology
HEALIX TRANSTEND ORTHOCORD PERCANNULA
FDA UDI
Medos International Sàrl·10886705023813·HEALIX TRANSTEND DS (PEEK/1) Implant System (1)...
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 16, 2020
TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Molekule Air Mini, Molekule Air Mini +
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014
CONTOUR TS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 15, 2011
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013