8 results
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17ms
·
Sources: EU EUDAMED, US FDA
PHENCYCLIDINE EIA ASSAY, MODIFICATION
FDA 510(k)
FDA Unclassified
·Unknown
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
ORACAM
FDA 510(k)
FDA Class 1
·Dental
FUJIFILM Endoscope Model EB-710P
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·January 17, 2013
PROTIME MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·November 10, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 9, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024