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

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CURVE IMAGE

FDA 510(k)
FDA Class 2 ·Radiology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450201251·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450312964·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450299562·

BD LOGIC BLOOD GLUCOSE MONITOR

FDA Adverse Event
Other ·BECTON DICKINSON·Product code CFR·July 29, 2003

ZURICH DISTRACTION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 24, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 24, 2024

ENDOTAK RELIANCE G

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 17, 2022

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·July 30, 2014

ANGIOJET SOLENT PROXI THROMBECTOMY SET

FDA Adverse Event
Other ·BAYER INTERVENTIONAL·Product code DXE·July 30, 2013

FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 13, 2013

OSCILL-SAW-ATTACHM F/532.001 532.010 532

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·September 23, 2014

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·May 19, 2011

BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 26, 2018

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·January 24, 2024

Spectral CT. Computed tomography X-ray system.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 2, 2025