27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NXSTAGE PUREFLOW SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033386·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
FDA 510(k)
FDA Class 1
·General Hospital
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
FDA 510(k)
FDA Class 2
·Radiology
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 29, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 24, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015
BD VACUTAINER® SINGLE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017
UNKNOWN DEPUY BEARING POLYETHYLENE
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 3, 2013
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·March 22, 2011
ETHICON ENDO-SURGERY, INC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. , JOHNSON AND JOHNSON·Product code IZH·April 23, 2008
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 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
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT 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 different 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·November 11, 2011