21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: OASYS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
OXF TWIN PEG CMNTLS FMRL SM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 7, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
FIBERED IDC OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·June 27, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·August 2, 2011
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
OSS-K DIAPHYSEAL SEGMENT 4CM W/SCREWS
FDA Adverse Event
Injury
·.·Product code JDI·May 5, 2017
OSS POROUS COATED BOWED IM STEM W/SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS POROUS COATED BOWED IM STEM W/SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS FEMORAL BUSHINGS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS 16MM TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS TIBIAL BUSHING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS-K 67 MM MODULAR POROUS COATED W/PLUG TIBIAL BASE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS POROUS COATED IM STEM W/SCREW - 11.5 MM X 90 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS LOCKING PIN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS SEGMENTAL FEMORAL - LEFT 7 CM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OXF ANAT BRG RT SM SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 7, 2020
OSS TM YOKE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017