13 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PTFE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131257703·H15, BTE 13 WL 100 CBE
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
BLOCK SCR F/IMPL F/TRANSPALATAL DISTRACT
FDA Adverse Event
Malfunction
·SYNTHES (USA) WEST CHESTER, PA·Product code MQN·May 29, 2013
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·June 13, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 21, 2008
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018