13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLAVICLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776362881·Oral Elevator, #40,
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028428·
CRYER ELEVATOR #40L
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code EMJ·September 18, 2019
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
FDA 510(k)
FDA Class 2
·Immunology
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 11, 2025
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015