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

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PATHWAY

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605531·MAQUET 1130 ORTHOPEDIC 3.25" DELUXE GEL

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450573334·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450160688·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197500692·VATS MICS Chest Tube Passer WL 280...

NA

FDA UDI
STRYKER CORPORATION·07613327052701·Insert, Tapered Bullet Dissector

WALLSTENT ENTERNAL PROSTHESIS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP

FDA 510(k)
FDA Class 3 ·Cardiovascular

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 5, 2023

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

FDA Adverse Event
Injury ·BARD SHANNON LIMITED·Product code FTL·April 24, 2013

STANDARD EXPANSION CLIP MARK III

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 6, 2011

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 22, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014