16 results · 29ms · Sources: EU EUDAMED, US FDA

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TINA-QUANT APOLIPOPROTEIN VER.2

FDA 510(k)
FDA Class 2 ·Immunology

MedStream

FDA UDI
MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472101225·DRESSING CHANGE KIT - CUSTOM

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

STEVE MADDEN

FDA UDI
FGX INTERNATIONAL INC.·00193033471159·

CCO/SvO2 update kit(international)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904085913·

PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228

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

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

MAXIM INTERLOK PS FEMORAL 75 LEFT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 20, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 6, 2011

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·H10·Product code KWP·April 4, 2013

SINGLE USE BIOPSY VALVE (STERILE)

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code EOQ·July 26, 2021

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

FDA Enforcement
Class II ·Terminated·Vision RT Ltd·October 10, 2018

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014