38 results · 22ms · Sources: EU EUDAMED, US FDA

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DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

FDA 510(k)
FDA Class 2 ·Radiology

Altus Spine Cervical Interbody Fusion System

FDA UDI
Altus Spine, LLC·00843210131054·ALR Sizer W/Tab

n/a

FDA UDI
Ortho Development Corporation·00822409088959·Modular Stem Inserter Threaded

Zavation

FDA UDI
Zavation LLC·00842166182110·Double Set Screw Inserter

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193107929·HA PEEK EVOS Straight, ,8mmx8mmx 26mm , FLAT 0...

Cutimed® Sorbion®

FDA UDI
BSN medical GmbH·04042809703184·CUTIMED SORBION BORDER SACRUM STERILE 19.5X22CM 10

OsteoMed

FDA UDI
OSTEOMED LLC·00845694054713·PrimaLIF Tissue Shim

CARDO MEDICAL CERAMIC HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

FDA 510(k)
FDA Class 2 ·General Hospital

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

BD NEEDLE ECLIPSE SMARTSLIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 16, 2025

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

FDA Recall
Terminated ·OrthoPediatrics Corp·Product code MBI·June 5, 2020

OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

FDA Recall
Terminated ·OrthoPediatrics Corp·Product code MBI·June 5, 2020

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2011

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 17, 2025

OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

FDA Enforcement
Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020