10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
FDA 510(k)
FDA Unclassified
·Unknown
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708720931·FILE, PULP CANAL, ENDODONTIC
PRISMAFLEX SYSTEM, VERSION 3.20
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Reprocessed Covidien Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
M2A MAGNUM MODULAR HD COCR 46MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 13, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 14, 2010
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 13, 2012
10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 24, 2018
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019