26 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TABLE TILT DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033316·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
OTI CERAMIC FEMORAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SICKLE-CHEX
FDA 510(k)
FDA Class 2
·Hematology
PERIPHERAL NERVE BLOCK SUPPORT TRAY
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code CAZ·October 1, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 3, 2013
E360 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 21, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·January 15, 2008
CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 2, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 3, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 1, 2014
PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·May 12, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER
FDA Adverse Event
Malfunction
·HALYARD HEALTH - IRVINE·Product code CAZ·November 8, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·July 1, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011
Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011