22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
FDA 510(k)
FDA Class 2
·Dental
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126940·
RONGEUR STELLBRINK 17 CM SLIGHT CURVE 2MM
FDA UDI
W.H. Holden, Inc.·D928100825600·
GE LOGIQ A100 MP, MODEL 2272413
FDA 510(k)
FDA Class 2
·Radiology
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
FDA 510(k)
FDA Class 2
·Immunology
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013
E.COM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 29, 2013
ALARIS PUMP MODULE IV ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·April 27, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 23, 2008
E.CAM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013
SHELL IMPACTION PLATFORM
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 13, 2019
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Enforcement
Class II
·Ongoing·Cytocell Ltd.·July 26, 2023
CFF71, 12X150 KII FIOS ADVFIX 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·January 7, 2019
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014