12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
FDA 510(k)
FDA Class 1
·Anesthesiology
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
FDA 510(k)
FDA Class 2
·Anesthesiology
S12 Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
HETTICH CENTRIFUGE
FDA Adverse Event
Malfunction
·ANDREAS HETTICH GMBH & CO. KG·Product code GKG·May 13, 2014
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 9, 2013
MEDFUSION 3010A SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·January 3, 2011
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 2014
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024