9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DIMERTEST LATEX
FDA 510(k)
FDA Class 2
·Hematology
JULIET PO
FDA 510(k)
FDA Class 2
·Orthopedic
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
VCF 4FR 65CM CATHETER
FDA Adverse Event
Injury
·COOK MEDICAL·Product code DYB·April 14, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 1, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 8, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2010
TRULIANT TIB IMP PS INSERT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 21, 2023
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
FDA Enforcement
Class II
·Terminated·GE Healthcare·April 1, 2015