27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BCI 3403 SLEEP SCREENING PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
9616240-2006-00341
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
9616240-2006-00332
FDA Adverse Event
Other
·Product code FII·June 1, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
9616240-2006-00339
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
9616240-2006-00340
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
SMARTMONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014
9616240-2006-00350
FDA Adverse Event
Malfunction
·Product code FII·June 23, 2006
9616240-2006-00345
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·April 10, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 6, 2011
REDDICH
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR INC·Product code GBZ·June 10, 2008
SMARTMONITOR 2 PROFESSIONAL SERIES
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·May 1, 2019