10 results · 19ms · Sources: EU EUDAMED, US FDA

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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