70 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

FDA 510(k)
FDA Class 2 ·Cardiovascular

STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

FDA Adverse Event
Other ·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010

VANGUARD REPROCESSED PULSE OXIMETER SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

2520274-2013-02245

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·April 29, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2011

TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·July 23, 2008

H 105700#TUBING SET

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015

HQV 32902#INTEGRATED ADULT PACK

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022

GLIDESHEATH

FDA Adverse Event
Death ·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020