13 results · 21ms · Sources: EU EUDAMED, 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