10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
FDA 510(k)
FDA Class 1
·General Hospital
CS 7600 Smart Plate
FDA UDI
CARESTREAM DENTAL LLC·40192155942514·CSD SMART PLATE SIZE 0 V2 - 4 PCS
icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm
FDA UDI
icotec AG·07640164848341·icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm
icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm
FDA UDI
icotec AG·07640140433967·icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm
U50 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TRANSVENOUS
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVN·February 4, 2013
FR2
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 23, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024