10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRU® Waxing Screw NP Short
FDA UDI
STERNGOLD DENTAL LLC·00841549117435·.050" Hex. Cylindrical stainless steel pins thr...
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 5, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 5, 2024
QUIDEL CHLAMYDIA TEST
FDA 510(k)
FDA Class 1
·Microbiology
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·May 23, 2014
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·January 4, 2013
REGENEREX RINGLOC 62MM MULTI HOLE ACETABULAR CUP SIZE 25
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 22, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024