27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Premier K-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053293·FILES PKG 6 31MM 15
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053293·NIGHT WELLNESS 70, SIZE S, ROSA, GRADUATED COMP...
EXCITE DSC
FDA 510(k)
FDA Class 2
·Dental
NIPRO HYPODERMIC NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 20, 2016
VG DA 360 O/S TIB TRAY COCR 63
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2016
VG DA360 TIB BRG ARCM 71/75X24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 79/83 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 6, 2016
VG DA 360 O/S TIB TRAY COCR 71
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 1, 2016
BALLOON
FDA Adverse Event
Injury
·EXTERNAL MANUFACTURER·Product code DYB·April 11, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
FOUNDATION KNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·May 28, 2008
VG DA 360 O/S TIB TRAY COCR 67
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 3, 2018
VANGUARD DA360 TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 14, 2017
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 6, 2017
VG DA 360 TIB BRG ARCM 79/83X14
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 19, 2016
VANGUARD DA360 TIBIAL BEARING 63/67X18
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016