42 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medtronic O-arm O2 Imaging System
FDA 510(k)
FDA Class 2
·Radiology
38 MM MODULAR HEAD PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304003163·
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRIMUS AESTHETIC PLATFORM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
FDA 510(k)
FDA Class 2
·Radiology
PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019
M2A 38MM NON-FLARED ONE-PIECE CUP 39MM I.D. X 52MM O.D / POROUS COATED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 7, 2016
M2A 1 PC SHELL 38MMX52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 6, 2019
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 17, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 25, 2008
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 1, 2020
MLRY-HD POR FMRL 11X160MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 27, 2020
TAPERLOC POR LAT FMRL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 22, 2017
M2A 1 PC SHELL 38MMX52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 3, 2019
MLRY-HD LAT POR FMRL 11X160MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2019
UNKOWN M2A 38 HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 27, 2013
M2A-38 CUP 56MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 27, 2018
M2A-38 NON FLARED ONE-PIECE CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 8, 2017
M2A-38 CUP NON FLARED SIZE 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 16, 2017